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El impacto del patrón dietético en la función eréctil (ERECTION)

22 de julio de 2026 actualizado por: Montefiore Medical Center

El impacto de una dieta basada en plantas frente a una dieta basada en animales sobre la función eréctil en hombres sanos con función eréctil normal: el estudio ERECTION

El objetivo de este estudio es determinar si la función eréctil se ve afectada por los patrones dietéticos en hombres sanos con una función eréctil normal.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Descripción detallada

Visita 1:

Después de revisar y firmar el consentimiento, los sujetos serán evaluados. La proyección consistirá en:

Complete IIEF (Índice Internacional de Función Eréctil) y un cuestionario de frecuencia de alimentos.

Registrar el historial médico, los medicamentos. Medir la altura y el peso. Signos vitales. Extraer sangre para determinar la testosterona total, la globulina fijadora de hormonas sexuales y la TSH (hormona estimulante de la tiroides). Se preguntará a los sujetos sobre la presencia de erupciones o lesiones genitales.

Si la puntuación del IIEF es anormal, se recomendará a los sujetos que se comuniquen con el PCP (proveedor de atención primaria).

Los sujetos serán contactados con los resultados de las pruebas de laboratorio. Si es anormal, se recomendará al sujeto que se comunique con el PCP.

Si el sujeto no tiene PCP, se proporcionará la información de contacto de un PCP. Los sujetos que cumplan con los criterios de inclusión y exclusión serán aleatorizados en la secuencia uno o en la secuencia dos. Una vez inscritos, los sujetos no modificarán los hábitos dietéticos durante la duración del estudio, excepto durante las dos noches y los dos días completos en los que se proporciona comida (ver más abajo).

Secuencia uno:

Visita 2:

Los sujetos regresan al centro de estudio por la mañana después de haber ayunado (aparte de consumir agua) desde las 23:00 horas de la noche anterior. Los sujetos no se cepillarán los dientes ni usarán enjuague bucal u otros refrescantes del aliento esa mañana. Se realizarán registros antropomórficos, de presión arterial y de frecuencia cardiaca. Se extraerá sangre y se almacenará. La orina será recolectada y almacenada. A los sujetos se les enseñará cómo usar el dispositivo Rigiscan™. Los sujetos recibirán una cena a base de plantas. Luego, los sujetos abandonarán el centro de estudio y consumirán la dieta habitual hasta las 5:00 p. m. Durante el resto de la noche hasta las 23:00, los sujetos consumirán solo la cena proporcionada. El agua será la única bebida permitida después de las 5:00 p. m. La cena debe consumirse a las 8:30 p. m., EST (hora estándar del este). Los sujetos enviarán imágenes de todo lo que se consume (comer o beber) después de las 5:00 p. m. al IP o a un representante del estudio. Un miembro del equipo del estudio tendrá contacto verbal o de texto con el sujeto al menos una vez esa noche. Los sujetos ayunarán aparte del agua después de las 11 p.m. Esa noche, los sujetos harán una evaluación Rigiscan™ durante la noche en casa. Se debe registrar la hora a la que el sujeto se acuesta y la hora a la que se despierta para el día. El sujeto acepta estar en la cama con Rigiscan™ activado (excepto en casos de emergencia o necesarios para ir al baño) durante al menos siete horas.

Visita 3:

Los sujetos regresan al centro de estudio la mañana después de la evaluación Rigiscan™ y traen el dispositivo Rigiscan™. Los sujetos habrán estado en ayunas que no hayan bebido agua desde las 11 p. m. de la noche anterior. Los sujetos no se cepillarán los dientes ni usarán enjuague bucal u otros refrescantes del aliento esa mañana. Se realizarán registros antropomórficos, de presión arterial y de frecuencia cardiaca. Se extraerá sangre y se almacenará. La orina será recolectada y almacenada. Luego, los sujetos recibirán un día completo de comidas a base de plantas. Se alentará a los sujetos a desayunar en el centro de estudio después de que se realicen las medidas antropomórficas iniciales, se extraiga sangre y se recolecte la orina. Los sujetos enviarán por mensaje de texto imágenes de todo lo que se consume durante ese día al PI y/o a un representante del estudio y un miembro del equipo de estudio tendrá contacto verbal o de texto con el sujeto al menos dos veces durante ese día. La cena debe consumirse a las 8:30 p. m., EST. Los sujetos ayunarán aparte del agua después de las 11 p.m. Esa noche, los sujetos harán una evaluación Rigiscan™ durante la noche en casa. El café solo y/o el té solo están permitidos antes del mediodía. Se debe registrar la hora a la que el sujeto se acuesta y la hora a la que se despierta para el día. El sujeto acepta estar en la cama con Rigiscan™ activado (excepto en casos de emergencia o necesarios para ir al baño) durante al menos siete horas.

Visita 4:

Los sujetos regresan al centro de estudio la mañana después de la evaluación Rigiscan™ y traen el dispositivo Rigiscan™. Los sujetos no se cepillarán los dientes ni usarán enjuague bucal u otros refrescantes del aliento esa mañana. Se realizarán registros antropomórficos, de presión arterial y de frecuencia cardiaca. Se extraerá sangre y se almacenará. La orina será recolectada y almacenada. Luego habrá un período de lavado de 8 a 12 días y se indicará a los sujetos que vuelvan a sus hábitos dietéticos habituales durante este período de lavado.

Visita 5:

Después del período de lavado, los sujetos regresan al centro de estudio por la mañana después de haber ayunado (aparte de consumir agua) desde las 11:00 p. m. de la noche anterior. Los sujetos no se cepillarán los dientes ni usarán enjuague bucal u otros refrescantes del aliento esa mañana. Se realizarán registros antropomórficos, de presión arterial y de frecuencia cardiaca. Se extraerá sangre y se almacenará. La orina será recolectada y almacenada. Los sujetos recibirán una cena basada en animales. Luego, los sujetos abandonarán el centro de estudio y consumirán la dieta habitual hasta las 5:00 p. m. Durante el resto de la noche hasta las 23:00, los sujetos consumirán solo la cena proporcionada. El agua será la única bebida consumida después de las 17:00 horas. La cena debe consumirse a las 8:30 p. m., EST. Los sujetos enviarán imágenes de todo lo que se consume (comer o beber) después de las 5:00 p. m. al IP o a un representante del estudio y un miembro del equipo del estudio tendrá contacto verbal o de texto con el sujeto al menos una vez esa noche. Los sujetos ayunarán aparte del agua después de las 11 p.m. Esa noche, los sujetos harán una evaluación Rigiscan™ durante la noche en casa. Se debe registrar la hora a la que el sujeto se acuesta y la hora a la que se despierta para el día. El sujeto acepta estar en la cama con Rigiscan™ activado (excepto en casos de emergencia o necesarios para ir al baño) durante al menos siete horas.

Visita 6:

Los sujetos regresan al centro de estudio la mañana después de la evaluación Rigiscan™ y traen el dispositivo Rigiscan™. Los sujetos no se cepillarán los dientes ni usarán enjuague bucal u otros refrescantes del aliento esa mañana. Se realizarán registros antropomórficos, de presión arterial y EndoPAT™. La saliva se almacenará. Se extraerá sangre y se almacenará. Luego, los sujetos recibirán un día completo de comidas basadas en animales. Se alentará a los sujetos a desayunar en el centro de estudio después de que se realicen las medidas antropomórficas iniciales, se obtenga saliva y se extraiga sangre. Los sujetos enviarán por mensaje de texto imágenes de todo lo que se consume durante ese día al PI y/o a un representante del estudio y el equipo del estudio tendrá contacto verbal o de texto con el sujeto al menos dos veces durante ese día. La cena debe consumirse a las 8:30 p. m., EST. Los sujetos ayunarán aparte del agua después de las 11 p.m. Esa noche, los sujetos harán una evaluación Rigiscan™ durante la noche en casa. El café solo y/o el té solo están permitidos antes del mediodía. Se debe registrar la hora a la que el sujeto se acuesta y la hora a la que se despierta para el día. El sujeto acepta estar en la cama con Rigiscan™ activado (excepto en casos de emergencia o necesarios para ir al baño) durante al menos siete horas.

Visita 7 (fin del estudio):

Los sujetos regresan al centro de estudio la mañana después de la evaluación Rigiscan™ y traen el dispositivo Rigiscan™. Los sujetos no se cepillarán los dientes ni usarán enjuague bucal u otros refrescantes del aliento esa mañana. Se realizarán registros antropomórficos, de presión arterial y de frecuencia cardiaca. Se extraerá sangre y se almacenará. La orina será recolectada y almacenada.

Secuencia dos:

La Secuencia dos es idéntica a la Secuencia uno, excepto que se proporcionan comidas a base de animales en lugar de comidas a base de plantas. Para los sujetos asignados al azar a comidas de origen animal en la Secuencia Uno y la Secuencia Dos, será idéntico excepto que se proporcionarán comidas de origen vegetal en lugar de comidas de origen animal.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

46

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

    • New York
      • The Bronx, New York, Estados Unidos, 10467
        • Reclutamiento
        • Montefiore Medical Center, Department of Medicine, Division of Cardiology
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

14 años a 25 años (Adulto)

Acepta Voluntarios Saludables

Descripción

Criterios de inclusión:

  • El sujeto proporciona el consentimiento informado por escrito y la autorización HIPAA en inglés antes de realizar cualquier procedimiento del estudio;
  • Sin terapia médica (aparte de MDI prn (inhaladores de dosis medida) y sin cambios en los suplementos, si corresponde)
  • Puntaje IIEF mayor o igual a 22
  • El sujeto habrá tenido sexo pene-vaginal dentro de las 4 semanas posteriores a la inscripción. La puntuación del IIEF utilizada se valida en función de esta ventana de tiempo.
  • Hombre de 18 a 29 años
  • Vive a poca distancia del sistema de salud de Montefiore
  • La pareja del sujeto (si corresponde) acepta apoyar al sujeto durante el estudio
  • El sujeto acepta fotografiar y compartir todos los artículos consumidos/bebidos durante la intervención dietética
  • El sujeto acepta evitar todas las drogas ilícitas, AINE y alcohol durante al menos dos días antes de la grabación con Rigiscan™ y en los días y noches de la grabación con Rigiscan™
  • El sujeto acepta abstenerse de actividad sexual durante al menos 36 horas antes de la colocación de Rigiscan™ y no tener actividad sexual en los días y noches de grabación de Rigiscan™.
  • El sujeto acepta no ver, leer o consumir material erótico o pornográfico durante al menos 36 horas antes de los días y noches de grabación Rigiscan™ y en los días y noches de grabación Rigiscan™
  • El sujeto acepta venir a Montefiore para someterse a la formación Rigiscan™
  • El sujeto acepta consumir/beber únicamente alimentos/bebidas permitidas.
  • El sujeto acepta asistir a todas las visitas en persona en Montefiore, comenzar a ayunar a las 11 p. m. la noche anterior a cada visita y someterse a todas las extracciones de sangre, saliva u otras pruebas.
  • El sujeto acepta no usar enjuagues bucales o enjuagues bucales ni escupir intencionalmente durante toda la duración del estudio. Se les pedirá a los sujetos que se abstengan de usar enjuague bucal durante al menos 2 días antes de la inscripción. El sujeto acepta no cepillarse los dientes en la mañana del día de cada visita de estudio. De lo contrario, se permite el cepillado de dientes.
  • IMC menor a 30, IMC mayor o igual a 18.5, peso mayor a 110 lbs.
  • El sujeto acepta cumplir con los procedimientos y visitas del estudio.
  • Ejercicios de sujetos durante al menos 15 minutos al menos dos veces por semana. El sujeto acepta evitar el ejercicio el día anterior y el día de las mediciones Rigiscan™

Criterio de exclusión:

  • Alergia dietética relevante
  • Patrón dietético vegetariano o vegano
  • Antecedentes de un trastorno alimentario; evidencia de adicción a la comida
  • Hipertensión o antecedentes de hipertensión con o sin tratamiento médico
  • IMC mayor o igual a 30, IMC menor a 18.5 o peso menor o igual a 110 libras
  • Enfermedad médica crónica conocida distinta de la enfermedad musculoesquelética no inflamatoria y el asma
  • Antecedentes de enfermedad renal o hiperpotasemia
  • El sujeto ha recibido un fármaco en investigación dentro de los 30 días anteriores a la firma del consentimiento
  • Disfunción eréctil
  • Tiene cualquier condición (p. ej., enfermedad psiquiátrica) o situación que, en opinión del investigador, pueda confundir los resultados del estudio o pueda interferir significativamente con la capacidad del paciente para cumplir con los procedimientos del estudio.
  • Actualmente en tratamiento para la enfermedad de Peyronie
  • Nivel anormal de testosterona o hormona estimulante de la tiroides
  • Hipogonadismo o hipotiroidismo tratados
  • Viajes planificados durante el estudio.
  • Historial de abuso de sustancias en los últimos 12 meses
  • Uso de drogas ilícitas, fumar o vapear dentro de las 4 semanas
  • Enfermedad de las vías respiratorias superiores dentro de las dos semanas posteriores a la detección
  • Si la profesión requiere estar de guardia, no debe pasar la noche o estar de guardia durante el estudio.
  • Cualquier enfermedad transmisible de la piel o venérea. El sujeto informa sarpullido o lesiones en el pene o el área circundante. Se le preguntará al sujeto: "¿Tiene un sarpullido o una lesión en el pene o en el área circundante?"

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Brazo a base de plantas
El brazo basado en plantas consta de 3 visitas al centro de investigación clínica, siguiendo una dieta basada en plantas y utilizando el dispositivo Rigiscan™ para medir la frecuencia, la rigidez y la duración de las erecciones nocturnas.
Los alimentos serán proporcionados por Montefiore-Einstein Food Services
Comparador activo: Brazo basado en animales
El grupo basado en animales consta de 3 visitas al centro de investigación clínica, siguiendo una dieta basada en animales y utilizando el dispositivo Rigiscan™ para medir la frecuencia, la rigidez y la duración de las erecciones nocturnas.
Los alimentos serán proporcionados por Montefiore-Einstein Food Services

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percent of time ≥60% erect during overnight Rigiscan™ use after 4 meals.
Periodo de tiempo: During overnight Rigiscan™ use directly after consuming the 4 meals. (The second night of Rigiscan™ use).
The first 5 minutes of Rigiscan™ recording is discarded. Erection time is the total time (in minutes) when penile rigidity is ≥ 60% at both the tip and base of the penis with a concurrent increase in penile tumescence at both the tip and base of the penis compared to baseline tumescence as measured by Rigiscan™ during overnight Rigiscan™ use, divided by the total time (in minutes) of overnight Rigiscan™ use. Overnight Rigiscan™ use time is defined as starting 5 minutes after the start of the Rigiscan™ recording and the end of Rigiscan™ use is defined as the last time the tip or base was >=10% rigid with a corresponding concurrent increase in penile tumescence at the tip or base compared to baseline tumesence. This total time window from start to end is the Rigiscan™ use time.
During overnight Rigiscan™ use directly after consuming the 4 meals. (The second night of Rigiscan™ use).

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percent of time ≥60% erect during overnight Rigiscan™ use after 1 meal.
Periodo de tiempo: During overnight Rigiscan™ use directly after consuming 1 meal. (The first night of Rigiscan™ use).
The first 5 minutes of Rigiscan™ recording is discarded. Erection time is the total time (in minutes) when penile rigidity is ≥ 60% at both the tip and base of the penis with a concurrent increase in penile tumescence at both the tip and base of the penis compared to baseline tumescence as measured by Rigiscan™ during overnight Rigiscan™ use, divided by the total time (in minutes) of overnight Rigiscan™ use. Overnight Rigiscan™ use time is defined as starting 5 minutes after the start of the Rigiscan™ recording and the end of Rigiscan™ use is defined as the last time the tip or base was >=10% rigid with a corresponding concurrent increase in penile tumescence at the tip or base compared to baseline tumesence. This total time window from start to end is the Rigiscan™ use time
During overnight Rigiscan™ use directly after consuming 1 meal. (The first night of Rigiscan™ use).
Percent of time ≥60% erect during overnight Rigiscan™ use after 4 meals, where each erection lasts >=5 minutes as measured by Rigiscan™
Periodo de tiempo: During overnight Rigiscan™ use directly after consuming 4 meals. (The second night of Rigiscan™ use).
The first 5 minutes of Rigiscan™ recording is discarded. Erection time is the total time (in minutes) when penile rigidity is ≥ 60% at both the tip and the base of the penis with a concurrent increase in penile tumescence at both the tip and base of the penis compared to baseline tumescence, and the erection lasts >= 5 minutes, as measured by Rigiscan™ during overnight Rigiscan™ use, divided by the total time (in minutes) of overnight Rigiscan™ use. Overnight Rigiscan™ use time is defined as starting 5 minutes after the start of the Rigiscan™ recording and the end of Rigiscan™ use is defined as the last time the tip or base was >=10% rigid with a corresponding concurrent increase in penile tumescence at the tip or base compared to baseline tumesence. This total time window from start to end is the Rigiscan™ use time.
During overnight Rigiscan™ use directly after consuming 4 meals. (The second night of Rigiscan™ use).
Percent of time ≥60% erect during overnight Rigiscan™ use after 1 meal, where each erection lasts >=5 minutes as measured by Rigiscan™
Periodo de tiempo: During overnight Rigiscan™ use directly after consuming 1 meal. (The first night of Rigiscan™ use).
The first 5 minutes of Rigiscan™ recording is discarded. Erection time is the total time (in minutes) when penile rigidity is ≥ 60% at both the tip and the base of the penis with a concurrent increase in penile tumescence at both the tip and base of the penis compared to baseline tumescence, and the erection lasts >= 5 minutes, as measured by Rigiscan™ during overnight Rigiscan™ use, divided by the total time (in minutes) of overnight Rigiscan™ use. Overnight Rigiscan™ use time is defined as starting 5 minutes after the start of the Rigiscan™ recording and the end of Rigiscan™ use is defined as the last time the tip or base was >=10% rigid with a corresponding concurrent increase in penile tumescence at the tip or base compared to baseline tumesence. This total time window from start to end is the Rigiscan™ use time.
During overnight Rigiscan™ use directly after consuming 1 meal. (The first night of Rigiscan™ use).

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Heart rate
Periodo de tiempo: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing heart rate by dietary pattern at both time points (after overnight Rigiscan™ use after consuming the 1 meal and after overnight Rigiscan™ use after consuming the 4 meals) and compared to its respective baseline in beats/minute. Definition: In regard to the following anthropometric, vital sign, and laboratory data (blood, urine, and saliva) pre-specified outcomes included in this pre-specified outcomes section, at "both time points" is defined as in the sentence above and "respective baseline" refers to either visit 2 or visit 5, as visit 2 is the baseline for one dietary arm (plant or animal) and visit 5 is the baseline for the other dietary arm (plant or animal).
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Blood Pressure
Periodo de tiempo: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing blood pressure by dietary pattern at both time points and compared to its respective baseline in mmHg
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Weight
Periodo de tiempo: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing weight by dietary pattern at both time points and compared to its respective baseline
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Fibrinogen
Periodo de tiempo: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in mg/dL
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
D-dimer
Periodo de tiempo: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in ng/mL
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Total cholesterol
Periodo de tiempo: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in mg/dL
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
HDL cholesterol
Periodo de tiempo: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in mg/dL
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
HDL efflux capacity
Periodo de tiempo: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline.
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
LDL cholesterol
Periodo de tiempo: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in mg/dL
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Triglyceride
Periodo de tiempo: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in mg/dL
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Oxidized LDL cholesterol
Periodo de tiempo: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in U/L
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Free Fatty Acids
Periodo de tiempo: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in micromoles
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Myeloperoxidase
Periodo de tiempo: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in ug/L
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Factor VII
Periodo de tiempo: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in percentage.
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
lysolecithin
Periodo de tiempo: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in mg/mL
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Apolipoprotein B
Periodo de tiempo: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in mg/dL
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Omega 3 index
Periodo de tiempo: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in percentage of erythrocyte fatty acid
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Lipoprotein-associated phospholipase-A2 (Lp PLA2) activity
Periodo de tiempo: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in nmol/min/mL
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Lipoprotein (a)
Periodo de tiempo: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in nmol/L
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Homocysteine
Periodo de tiempo: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in umol/L
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
methylmalonic acid (MMA)
Periodo de tiempo: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in umol/L
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Asymmetric Dimethylarginine (ADMA)
Periodo de tiempo: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in umol/L
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
symmetric dimethylarginine (SDMA)
Periodo de tiempo: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in mg/dL
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Total testosterone
Periodo de tiempo: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in mg/dL
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Sex Hormone Binding Globulin
Periodo de tiempo: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in nmol/L
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
cystatin C
Periodo de tiempo: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in mg/dL
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
remnant cholesterol particles
Periodo de tiempo: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in mg/dL
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
uric acid
Periodo de tiempo: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in mg/dL
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
interleukin 1
Periodo de tiempo: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in pg/mL
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
interleukin 6
Periodo de tiempo: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in pg/mL
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
hsCRP
Periodo de tiempo: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in mg/L
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Blood Urea Nitrogen (BUN)
Periodo de tiempo: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in mg/dL
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Carbon Dioxide (CO2)
Periodo de tiempo: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in mmol/L
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
creatinine
Periodo de tiempo: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in mg/dL
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
glucose
Periodo de tiempo: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in mg/dL
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
serum chloride
Periodo de tiempo: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in meq/L
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
serum potassium
Periodo de tiempo: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in meq/L
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
serum sodium
Periodo de tiempo: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in meq/L
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
alanine aminotransferase (ALT)
Periodo de tiempo: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in units/L
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
aspartate aminotransferase (AST)
Periodo de tiempo: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in units/L
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
estimated glomerular filtration rate (eGFR)
Periodo de tiempo: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in mL/min/1.73m2
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
vitamin c
Periodo de tiempo: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in mg/dL
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
reduced glutathione
Periodo de tiempo: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in umol/L
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
superoxide dismutase
Periodo de tiempo: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in ng/mL
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
vitamin e
Periodo de tiempo: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in mg/L
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
selenium
Periodo de tiempo: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in ng/mL
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
malondialdehyde
Periodo de tiempo: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in umol/L
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
non coding RNA
Periodo de tiempo: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in copies/mL
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
micro RNA
Periodo de tiempo: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in copies/mL
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Lnc RNA
Periodo de tiempo: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in copies/mL
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
trimethylamine-N-oxide (TMAO)
Periodo de tiempo: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in umol/L
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
phenylacetylglutamine (PAG)
Periodo de tiempo: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in uM (micrometers)
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing urine albumin-to-creatinine ratio (UACR)
Periodo de tiempo: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in mg/g
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing salivary nitrite level as a correlate of plasma nitric oxide (NO) level
Periodo de tiempo: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in micromoles/L
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing salivary nitrate level in as a correlate of plasma nitric oxide (NO) level
Periodo de tiempo: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in micromoles/L
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Platelets
Periodo de tiempo: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in cells/ul.
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
FIB-4 Index
Periodo de tiempo: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Percent of time ≥50% erect during overnight Rigiscan™ use after the 4 meals.
Periodo de tiempo: During overnight Rigiscan™ use directly after consuming the 4 meals. (The second night of Rigiscan™ use).
The first 5 minutes of Rigiscan™ recording is discarded. Erection time is the total time (in minutes) when penile rigidity is ≥ 50% at both the tip and base of the penis with a concurrent increase in penile tumescence at both the tip and base of the penis compared to baseline tumescence as measured by Rigiscan™ during overnight Rigiscan™ use, divided by the total time (in minutes) of overnight Rigiscan™ use. Overnight Rigiscan™ use time is defined as starting 5 minutes after the start of the Rigiscan™ recording and the end of Rigiscan™ use is defined as the last time the tip or base was >=10% rigid with a corresponding concurrent increase in penile tumescence at the tip or base compared to baseline tumesence. This total time window from start to end is the Rigiscan™ use time.
During overnight Rigiscan™ use directly after consuming the 4 meals. (The second night of Rigiscan™ use).
Percent of time ≥50% erect during overnight Rigiscan™ use after 1 meal.
Periodo de tiempo: During overnight Rigiscan™ use directly after consuming 1 meal. (The first night of Rigiscan™ use)
The first 5 minutes of Rigiscan™ recording is discarded. Erection time is the total time (in minutes) when penile rigidity is ≥ 50% at both the tip and base of the penis with a concurrent increase in penile tumescence at both the tip and base of the penis compared to baseline tumescence as measured by Rigiscan™ during overnight Rigiscan™ use, divided by the total time (in minutes) of overnight Rigiscan™ use. Overnight Rigiscan™ use time is defined as starting 5 minutes after the start of the Rigiscan™ recording and the end of Rigiscan™ use is defined as the last time the tip or base was >=10% rigid with a corresponding concurrent increase in penile tumescence at the tip or base compared to baseline tumesence. This total time window from start to end is the Rigiscan™ use time
During overnight Rigiscan™ use directly after consuming 1 meal. (The first night of Rigiscan™ use)
Percent of time ≥70% erect during overnight Rigiscan™ use after 4 meals.
Periodo de tiempo: During overnight Rigiscan™ use directly after consuming the 4 meals. (The second night of Rigiscan™ use).
The first 5 minutes of Rigiscan™ recording is discarded. Erection time is the total time (in minutes) when penile rigidity is ≥ 70% at both the tip and base of the penis with a concurrent increase in penile tumescence at both the tip and base of the penis compared to baseline tumescence as measured by Rigiscan™ during overnight Rigiscan™ use, divided by the total time (in minutes) of overnight Rigiscan™ use. Overnight Rigiscan™ use time is defined as starting 5 minutes after the start of the Rigiscan™ recording and the end of Rigiscan™ use is defined as the last time the tip or base was >=10% rigid with a corresponding concurrent increase in penile tumescence at the tip or base compared to baseline tumesence. This total time window from start to end is the Rigiscan™ use time
During overnight Rigiscan™ use directly after consuming the 4 meals. (The second night of Rigiscan™ use).
Percent of time ≥70% erect during overnight Rigiscan™ use after 1 meal.
Periodo de tiempo: During overnight Rigiscan™ use directly after consuming 1 meal. (The first night of Rigiscan™ use).
The first 5 minutes of Rigiscan™ recording is discarded. Erection time is the total time (in minutes) when penile rigidity is ≥ 70% at both the tip and base of the penis with a concurrent increase in penile tumescence at both the tip and base of the penis compared to baseline tumescence as measured by Rigiscan™ during overnight Rigiscan™ use, divided by the total time (in minutes) of overnight Rigiscan™ use. Overnight Rigiscan™ use time is defined as starting 5 minutes after the start of the Rigiscan™ recording and the end of Rigiscan™ use is defined as the last time the tip or base was >=10% rigid with a corresponding concurrent increase in penile tumescence at the tip or base compared to baseline tumesence. This total time window from start to end is the Rigiscan™ use time
During overnight Rigiscan™ use directly after consuming 1 meal. (The first night of Rigiscan™ use).
Percent of time ≥70% erect during overnight Rigiscan™ use after 4 meals versus after 1 meal by dietary pattern.
Periodo de tiempo: During overnight Rigiscan™ use directly after consuming the 4 meals versus overnight Rigiscan™ use directly after consuming the 1 meal by dietary pattern, for each dietary pattern.
The first 5 minutes of Rigiscan™ recording is discarded. Erection time is the total time (in minutes) when penile rigidity is ≥ 70% at both the tip and base of the penis with a concurrent increase in penile tumescence at both the tip and base of the penis compared to baseline tumescence as measured by Rigiscan™ during overnight Rigiscan™ use, divided by the total time (in minutes) of overnight Rigiscan™ use. Overnight Rigiscan™ use time is defined as starting 5 minutes after the start of the Rigiscan™ recording and the end of Rigiscan™ use is defined as the last time the tip or base was >=10% rigid with a corresponding concurrent increase in penile tumescence at the tip or base compared to baseline tumesence. This total time window from start to end is the Rigiscan™ use time.
During overnight Rigiscan™ use directly after consuming the 4 meals versus overnight Rigiscan™ use directly after consuming the 1 meal by dietary pattern, for each dietary pattern.
Percent of time ≥60% erect during overnight Rigiscan™ use after 4 meals versus after 1 meal by dietary pattern.
Periodo de tiempo: During overnight Rigiscan™ use directly after consuming the 4 meals versus overnight Rigiscan™ use directly after consuming the 1 meal by dietary pattern, for each dietary pattern.
The first 5 minutes of Rigiscan™ recording is discarded. Erection time is the total time (in minutes) when penile rigidity is ≥ 60% at both the tip and base of the penis with a concurrent increase in penile tumescence at both the tip and base of the penis compared to baseline tumescence as measured by Rigiscan™ during overnight Rigiscan™ use, divided by the total time (in minutes) of overnight Rigiscan™ use. Overnight Rigiscan™ use time is defined as starting 5 minutes after the start of the Rigiscan™ recording and the end of Rigiscan™ use is defined as the last time the tip or base was >=10% rigid with a corresponding concurrent increase in penile tumescence at the tip or base compared to baseline tumesence. This total time window from start to end is the Rigiscan™ use time.
During overnight Rigiscan™ use directly after consuming the 4 meals versus overnight Rigiscan™ use directly after consuming the 1 meal by dietary pattern, for each dietary pattern.
Percent of time ≥50% erect during overnight Rigiscan™ use after 4 meals versus after 1 meal by dietary pattern.
Periodo de tiempo: During overnight Rigiscan™ use directly after consuming the 4 meals versus overnight Rigiscan™ use directly after consuming the 1 meal by dietary pattern, for each dietary pattern.
The first 5 minutes of Rigiscan™ recording is discarded. Erection time is the total time (in minutes) when penile rigidity is ≥ 50% at both the tip and base of the penis with a concurrent increase in penile tumescence at both the tip and base of the penis compared to baseline tumescence as measured by Rigiscan™ during overnight Rigiscan™ use, divided by the total time (in minutes) of overnight Rigiscan™ use. Overnight Rigiscan™ use time is defined as starting 5 minutes after the start of the Rigiscan™ recording and the end of Rigiscan™ use is defined as the last time the tip or base was >=10% rigid with a corresponding concurrent increase in penile tumescence at the tip or base compared to baseline tumesence. This total time window from start to end is the Rigiscan™ use time.
During overnight Rigiscan™ use directly after consuming the 4 meals versus overnight Rigiscan™ use directly after consuming the 1 meal by dietary pattern, for each dietary pattern.
Percent of time ≥70% erect during overnight Rigiscan™ use after 4 meals, where each erection lasts >=5 minutes as measured by Rigiscan™
Periodo de tiempo: During overnight Rigiscan™ use directly after consuming 4 meals. (The second night of Rigiscan™ use).
The first 5 minutes of Rigiscan™ recording is discarded. Erection time is the total time (in minutes) when penile rigidity is ≥ 70% at both the tip and the base of the penis with a concurrent increase in penile tumescence at both the tip and base of the penis compared to baseline tumescence, and the erection lasts >= 5 minutes, as measured by Rigiscan™ during overnight Rigiscan™ use, divided by the total time (in minutes) of overnight Rigiscan™ use. Overnight Rigiscan™ use time is defined as starting 5 minutes after the start of the Rigiscan™ recording and the end of Rigiscan™ use is defined as the last time the tip or base was >=10% rigid with a corresponding concurrent increase in penile tumescence at the tip or base compared to baseline tumesence. This total time window from start to end is the Rigiscan™ use time.
During overnight Rigiscan™ use directly after consuming 4 meals. (The second night of Rigiscan™ use).
Percent of time ≥70% erect during overnight Rigiscan™ use after 1 meal, where each erection lasts >=5 minutes as measured by Rigiscan™
Periodo de tiempo: During overnight Rigiscan™ use directly after consuming 1 meal. (The first night of Rigiscan™ use).
The first 5 minutes of Rigiscan™ recording is discarded. Erection time is the total time (in minutes) when penile rigidity is ≥70% at both the tip and the base of the penis with a concurrent increase in penile tumescence at both the tip and base of the penis compared to baseline tumescence, and the erection lasts >= 5 minutes, as measured by Rigiscan™ during overnight Rigiscan™ use, divided by the total time (in minutes) of overnight Rigiscan™ use. Overnight Rigiscan™ use time is defined as starting 5 minutes after the start of the Rigiscan™ recording and the end of Rigiscan™ use is defined as the last time the tip or base was >=10% rigid with a corresponding concurrent increase in penile tumescence at the tip or base compared to baseline tumesence. This total time window from start to end is the Rigiscan™ use time.
During overnight Rigiscan™ use directly after consuming 1 meal. (The first night of Rigiscan™ use).
Percent of time ≥50% erect during overnight Rigiscan™ use after 4 meals, where each erection lasts >=5 minutes as measured by Rigiscan™
Periodo de tiempo: During overnight Rigiscan™ use directly after consuming 4 meals. (The second night of Rigiscan™ use).
The first 5 minutes of Rigiscan™ recording is discarded. Erection time is the total time (in minutes) when penile rigidity is ≥ 50% at both the tip and the base of the penis with a concurrent increase in penile tumescence at both the tip and base of the penis compared to baseline tumescence, and the erection lasts >= 5 minutes, as measured by Rigiscan™ during overnight Rigiscan™ use, divided by the total time (in minutes) of overnight Rigiscan™ use. Overnight Rigiscan™ use time is defined as starting 5 minutes after the start of the Rigiscan™ recording and the end of Rigiscan™ use is defined as the last time the tip or base was >=10% rigid with a corresponding concurrent increase in penile tumescence at the tip or base compared to baseline tumesence. This total time window from start to end is the Rigiscan™ use time.
During overnight Rigiscan™ use directly after consuming 4 meals. (The second night of Rigiscan™ use).
Percent of time ≥50% erect during overnight Rigiscan™ use after 1 meal, where each erection lasts >=5 minutes as measured by Rigiscan™
Periodo de tiempo: During overnight Rigiscan™ use directly after consuming 1 meal. (The first night of Rigiscan™ use).
The first 5 minutes of Rigiscan™ recording is discarded. Erection time is the total time (in minutes) when penile rigidity is ≥ 50% at both the tip and the base of the penis with a concurrent increase in penile tumescence at both the tip and base of the penis compared to baseline tumescence, and the erection lasts >= 5 minutes, as measured by Rigiscan™ during overnight Rigiscan™ use, divided by the total time (in minutes) of overnight Rigiscan™ use. Overnight Rigiscan™ use time is defined as starting 5 minutes after the start of the Rigiscan™ recording and the end of Rigiscan™ use is defined as the last time the tip or base was >=10% rigid with a corresponding concurrent increase in penile tumescence at the tip or base compared to baseline tumesence. This total time window from start to end is the Rigiscan™ use time.
During overnight Rigiscan™ use directly after consuming 1 meal. (The first night of Rigiscan™ use).

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Robert Ostfeld, MD, Montefiore Medical Center

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

30 de octubre de 2023

Finalización primaria (Estimado)

1 de diciembre de 2026

Finalización del estudio (Estimado)

1 de diciembre de 2026

Fechas de registro del estudio

Enviado por primera vez

27 de marzo de 2020

Primero enviado que cumplió con los criterios de control de calidad

15 de abril de 2020

Publicado por primera vez (Actual)

16 de abril de 2020

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

24 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

22 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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