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Acute Effects of Coffee Beverage on Postprandial Inflammation and Oxidative Stress - A Pilot Study (COF1)

The primary objective is to test if acute supplementation with Coffee would improve antioxidant status, following consumption of a pro-oxidative high carbohydrate, high fat meal in over weight/ obese humans.

Secondary objective is to determine the ability of coffee to modify postprandial inflammation in overweight/ obese humans.

Descripción general del estudio

Descripción detallada

The proposed study is a single-center, placebo-controlled, randomized, 2-arm, 2-sequence, crossover study that characterize the bioavailability and kinetic profile of coffee over 6-hour postprandial day (PPD).

A planned sample size of 10 will be recruited into the study. This study will require one initial screening visit, pre-study visit, and 2 PPDs. This study will take 3-6 weeks per subject to complete.

The trial will initiate with a screening visit, which will last for about 1-1.5 hours where the subjects' height, weight, waist circumference, fasting blood glucose, fasting hs-CRP (high sensitivity C-reactive protein) concentration, blood pressure and heart rate will be measured and a survey related to general eating, health and exercise habits will be completed.

If willing and eligible to participate, a 3-day food record (2 weekdays and 1 weekend) will be given at the screening visit and collected on the following pre-study Visit to assess subject's baseline dietary intake and pattern. Also, subjects will be instructed to follow a relatively low polyphenolic-diet at least 7 days prior to the first PPD and for the duration of the study. Prior to each PPD, a dinner meal will be provided the day before the PPD to control the second meal effect from food and beverage intake of the night before the PPD.

Subjects will arrive at the center in a fasting state for at least 10 hours, well hydrated and rested. Each PPD will require blood draws throughout the visit. After evaluation of subject's health status (via anthropometric, vital sign and blood glucose measurements and in-person interview), a registered nurse will place a catheter in subject's arm for the purpose of multiple blood sample collections and take the initial blood draw in the fasting state. A standard high carbohydrate and high fat test meal with either 1 cup of coffee or 1 cup of hot water will be served. Thereafter, timers will be started and blood sample will be collected at 20, 40, 60, 120, 180, 240, 300, and 360 minutes for assessment of changes in inflammation markers and relative metabolic indices. The sequence of receiving the coffee or hot water treatment at each visit will be randomly assigned based on computer generated sequences: hot water- coffee or coffee-hot water.

Premenopausal female subjects will be studied during the follicular phase of their menstrual cycle because food intake tends to be more stable during the follicular phase (days 1-13) than during the luteal phase (days 14-28) when the rise in progesterone levels decrease satiety and often resulting in increased intake. Both PPD visits will be placed at least 3 days apart as well.

Tipo de estudio

Intervencionista

Inscripción (Actual)

9

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.

Ubicaciones de estudio

    • Illinois
      • Chicago, Illinois, Estados Unidos, 60616
        • Clinical Nutrition Research Center

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

20 años a 45 años (Adulto)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Femenino

Descripción

Inclusion Criteria:

  • Premenopausal women with regular menstrual cycle
  • Aged between 20 to 45 years old
  • Body Mass Index (BMI) range from 25 to 35 kg/m2; exception BMI 23 to 35 kg/m2 for Asian population
  • Fasting blood glucose concentration < 110 mg/dL
  • Fasting hs-CRP >2 mg/dL to < 10 mg/dL
  • Weight stable: not gained or lost weight +/- 5 lbs in previous 3 months
  • No clinical evidence of cardiovascular, metabolic, respiratory, renal, gastrointestinal or hepatic disease
  • Not taking any medications or dietary supplements that would interfere with outcomes of the study, i.e. lipid lowering medications, anti-inflammatory drugs, fish oil, probiotics, grape seed supplement, etc…If anti-inflammation and/or antibiotic medications/supplements are taken, subjects may qualify if go off these medications/supplements 30 days wash-out before entering the study.
  • Able to provide informed consent
  • Able to comply and perform the procedures requested by the protocol

Exclusion Criteria:

  • Men
  • Past smokers: abstinence for less than 2 years
  • Women who smoke
  • Women with known or suspected food intolerance, allergies or hypersensitivity to the study materials or closely related compound or any their stated ingredients.
  • Women known to have/diagnosed with diabetes mellitus
  • Women who have fasting blood glucose concentrations ≥110 mg/dL
  • Women with documented vascular disease, e.g., heart failure, myocardial infarction, stroke, angina, related surgeries.
  • Women with cancer other than non-melanoma skin cancer in previous 5 years.
  • Women who are taking medication or dietary supplements that may interfere with the outcomes of the study; e.g., antioxidant supplements, anti-inflammation, lipid lowering medication. Subjects may choose to go off dietary supplements (requires 30 days washout).
  • Women who are taking blood pressure lowering medication that may interfere with the outcomes of the study; e.g. diuretics.
  • Women who have donated blood within 3 months of the screening visit and blood donors/participants for whom participation in this study will result in having donated more than 1500 milliliters of blood in the previous 12 months.
  • Women who are vegetarians or vegans
  • Substance (alcohol or drug) abuse within the last 2 years.
  • Excessive coffee and tea consumers (> 4 cups/day); berry and grape consumers (>2 cups/day)
  • Women who do excessive exercise regularly or athlete
  • Unstable weight: gained or lost weight +/- 5 lbs in previous 3 months
  • Women who are known to be pregnant or who are intending to become pregnant over the course of the study
  • Women who are lactating

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: Ciencia básica
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador de placebos: Agua
Water
Otros nombres:
  • Comparador de placebos
Comparador activo: Coffee
Coffee Beverage
Coffee Beverage
Otros nombres:
  • Comparador activo

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Changes in plasma inflammation markers over 6 hours after coffee or hot water consumption with a high carbohydrate and high fat meal.
Periodo de tiempo: 6 hours
The influence of coffee consumption on inflammation markers
6 hours

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Changes in plasma metabolic markers over 6 hours after coffee or hot water consumption with a high carbohydrate and high fat meal
Periodo de tiempo: 6 hours
The influence of coffee consumption on metabolic markers
6 hours

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Changes in oxidative stress markers over 6 hours after coffee or hot water consumption with a high carbohydrate and high fat meal
Periodo de tiempo: 6 hours
The influence of coffee consumption on oxidative stress markers
6 hours

Colaboradores e Investigadores

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

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)

15 de junio de 2014

Finalización primaria (Actual)

27 de octubre de 2014

Finalización del estudio (Actual)

16 de diciembre de 2014

Fechas de registro del estudio

Enviado por primera vez

17 de junio de 2014

Primero enviado que cumplió con los criterios de control de calidad

23 de junio de 2014

Publicado por primera vez (Estimar)

25 de junio de 2014

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

28 de enero de 2021

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

26 de enero de 2021

Última verificación

1 de enero de 2021

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 2014-008

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

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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