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Expression of Longevity Genes in Response to Extended Fasting (FEELGOOD)

18 de abril de 2017 actualizado por: Intermountain Health Care, Inc.
The purpose of this study is to evaluate the effect of fasting on physical changes associated with cardiovascular disease.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Coronary heart disease (CHD) is the largest contributor to morbidity and mortality in the Western world and is associated with high-calorie diet, high body mass, and a variety of other factors. CHD can lead to myocardial infarction (MI) and other embolic events. A growing body of evidence suggests that relatively low caloric intake in the diets of a variety of animals increases longevity and preliminary evidence among humans indicates that such caloric restriction reduces risk factors for CHD, including cholesterol levels, blood pressure, glucose, and obesity. Caloric restriction has also been shown to alter the expression of certain genes, especially the forkhead box (FOX) O and sirtuin (SIRT) genes whose over-expression has been shown to increase longevity in animal models. Extended avoidance of caloric intake, also called fasting or short-term starvation, has been shown to increase expression of the FOXA genes that have similar sequence and function as the FOXO genes and that have been shown to increase longevity among animals regardless of FOXO function. We recently demonstrated that the risk of CHD was significantly lower among patients who reported a history of routine periodic extended fasting. The two primary hypotheses for this observation are that fasting may improve individual ability to control dietary intake or that fasting may initiate a cascade of protective mechanisms that preserve cellular and metabolic health.

Tipo de estudio

Intervencionista

Inscripción (Actual)

30

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

  • Estados Unidos
    • Utah
      • Murray, Utah, Estados Unidos, 84107-5701
        • Intermountain Medical 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

18 años a 70 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. The volunteer (male or non-pregnant female, any ethnicity) must be >18 years of age.
  2. The volunteer must either have a body mass index of 25.0-35.0 kg/m2 or the combination of a body mass index of 18.5-24.9 kg/m2 and two or more previously or currently measured symptoms of the metabolic syndrome (fasting glucose≥110 mg/dL, triglycerides≥150 mg/dL, high-density lipoprotein cholesterol<40 mg/dL in males or <50 mg/dL in females, systolic blood pressure≥130 mmHg or diastolic blood pressure≥85 mmHg, or waist circumference≥40 inches in males or ≥36 inches in females [glucose and cholesterol levels may be self-reported]).
  3. The volunteer has not routinely participated in caloric restriction (deliberate limitation of caloric intake of <80% than the FDA-recommended daily caloric intake) within the last 2 years, has not participated in extended fasting (>12 hours at a time) for at least a year, and does not deliberately skip meals as a routine dietary practice.

Exclusion Criteria:

  1. Body mass index <18.5 or >35 kg/m2.
  2. Current active cancer treatment, treatment with immunosuppressive medications, or solid organ transplantation within 1 year.
  3. Presence of immunosuppressive disease, myocardial infarction, peripheral vascular disease, or stroke within the past year.
  4. Use of insulin.
  5. Although it is unlikely fasting will harm the pregnant or lactating woman, the dietary restrictions placed on the participant for the duration of the study may conflict with dietary recommendations for pregnant or lactating women. Women of child bearing potential, therefore, will meet an exclusion if they become pregnant.

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: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Otro: Fasting Day First
28±4 hours of water-only fasting followed by 28±4 hours fed
Conductual: Fasting First
28±4 hours of water-only fasting followed by 28±4 hours fed
Otro: Fed Day First
28± 4 hours fed followed by 28± 4 hours of fasting
Conductual: Fed First
28± 4 hours fed followed by 28± 4 hours of fasting

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change From Baseline in Participant Glucose When Fasting and Fed
Periodo de tiempo: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Human Growth Hormone (HGH) When Fasting and Fed
Periodo de tiempo: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Insulin When Fasting and Fed
Periodo de tiempo: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) When Fasting and Fed
Periodo de tiempo: Baseline and 3 days
HOMA-IR is used to measure the severity of insulin resistance. Healthy Range: 1.0 (0.5-1.4) Less than 1.0 is optimal Above 1.9 indicates early insulin resistance Above 2.9 indicates significant insulin resistance
Baseline and 3 days
Change From Baseline in Participant Glycogen-Like Protein-1 (GLP-1) When Fasting and Fed
Periodo de tiempo: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Adiponectin When Fasting and Fed
Periodo de tiempo: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Fibroblast Growth Factor-21 (FGF-21) When Fasting and Fed
Periodo de tiempo: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant White Blood Cell Count (WBC) When Fasting and Fed
Periodo de tiempo: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Hemoglobin When Fasting and Fed
Periodo de tiempo: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Red Blood Cell Count (RBC) When Fasting and Fed
Periodo de tiempo: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Hematocrit When Fasting and Fed
Periodo de tiempo: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Platelet Count When Fasting and Fed
Periodo de tiempo: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Mean Corpuscular Volume (MCV) When Fasting and Fed
Periodo de tiempo: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Mean Corpuscular Hemoglobin (MCH) When Fasting and Fed
Periodo de tiempo: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Mean Corpuscular Hemoglobin Concentration (MCHC) When Fasting and Fed
Periodo de tiempo: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Red Cell Distribution Width (RDW) When Fasting and Fed
Periodo de tiempo: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Mean Platelet Volume (MPV) When Fasting and Fed
Periodo de tiempo: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Bicarbonate When Fasting and Fed
Periodo de tiempo: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Sodium When Fasting and Fed
Periodo de tiempo: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Chloride When Fasting and Fed
Periodo de tiempo: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Blood Urea Nitrogen (BUN) When Fasting and Fed
Periodo de tiempo: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Calcium When Fasting and Fed
Periodo de tiempo: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Potassium When Fasting and Fed
Periodo de tiempo: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Creatinine When Fasting and Fed
Periodo de tiempo: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Total Cholesterol (TC) When Fasting and Fed
Periodo de tiempo: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Low-Density Lipoprotein Cholesterol (LDL-C) When Fasting and Fed
Periodo de tiempo: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant High-Density Lipoprotein Cholesterol (HDL-C) When Fasting and Fed
Periodo de tiempo: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Triglycerides When Fasting and Fed
Periodo de tiempo: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant TC/HDL Ratio When Fasting and Fed
Periodo de tiempo: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Weight When Fasting and Fed
Periodo de tiempo: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Waist Circumference When Fasting and Fed
Periodo de tiempo: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Systolic Blood Pressure (SBP), Supine When Fasting and Fed
Periodo de tiempo: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Diastolic Blood Pressure (DBP), Supine When Fasting and Fed
Periodo de tiempo: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant High Sensitivity C-Reactive Protein (hsCRP) When Fasting and Fed
Periodo de tiempo: Baseline and 3 days
Baseline and 3 days

Colaboradores e Investigadores

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

Patrocinador

Intermountain Health Care, Inc.

Investigadores

  • Investigador principal: Benjamin D Horne, PhD, Intermountain 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

1 de enero de 2010

Finalización primaria (Actual)

1 de agosto de 2010

Finalización del estudio (Actual)

1 de octubre de 2010

Fechas de registro del estudio

Enviado por primera vez

28 de enero de 2010

Primero enviado que cumplió con los criterios de control de calidad

29 de enero de 2010

Publicado por primera vez (Estimar)

1 de febrero de 2010

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

17 de julio de 2017

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

18 de abril de 2017

Última verificación

1 de marzo de 2011

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 154-002

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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