- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00798668
The Body's Response to Food Intake in Trained, Older Adults
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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-
Indiana
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West Lafayette, Indiana, Estados Unidos, 47907
- Purdue University
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
All subjects must meet the following eligibility criteria:
- Age range: 60 years and older
- Body mass index between 20-29 kg/m2
- Weight stable (< 2 kg weight change within last 6 months)
- Non-smoking
- Constant habitual activity patterns within last 3 months
- Clinically normal blood profiles (specifically, normal liver and kidney function; normal complete blood count (non-anemic); fasting blood glucose <110 mg/dl)
- Not taking medications known to influence appetite or metabolism
- Non-diabetic
- Confirmation of acceptability of eating the study test foods (solids and fluids)
Trained subjects (Recruiting 36; N-25) must meet the following eligibility criteria:
- Resistive exercise training (≥ 2 times a week) based on reported physical activity levels (questionnaire)
- Active fitness level (≥ 2, 30-minute aerobic exercise sessions/week)
Sedentary subjects (Recruiting 36; N-25) must meet the following eligibility criteria:
- Resistive exercise training (≤ 1 time a week) based on reported physical activity levels (questionnaire)
- Active fitness level (≤ 2, 30-minute aerobic exercise sessions/week)
Exclusion Criteria:
All subjects will be excluded based on the following exclusionary criteria:
- Age: <60 years
- Body mass index: outside of the 20-29 kg/m2 range
- Gained or lost > 4.5 kg within the last 6 months
- Smoker (currently or within the last year)
- Intermittently been involved in a diet and/or exercise program within the last 3 months
- Clinically abnormal blood profiles as identified by our study physician, Arthur Rosen, MD
- Taking medications (currently or within the last 3 months) known to influence appetite or metabolism
- Abnormal heart function (interpreted by a cardiologist) and assessed (for study exclusion) by our study physician, Arthur Rosen, MD
- Clinically diagnosed as diabetic
- Study foods are found to be unacceptable for consumption by the subject
- Clinically diagnosed osteoporosis
Trained subjects will be excluded based on the following exclusionary criteria:
- Did not perform resistive exercise training (currently or within the last 3 months) based on reported physical activity levels (questionnaire)
- Perform ≤ 1, 30-minute aerobic exercise session/week (currently or within the last 3 months) based on physical activity levels questionnaire)
Sedentary subjects will be excluded based on the following exclusionary criteria:
- Performed resistive exercise training (currently or within the last 3 months) based on reported physical activity levels (questionnaire)
- Perform > 2, 30-minute aerobic exercise sessions/week (currently or within the last 3 months) based on physical activity levels questionnaire)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 1
participants continue current exercise and take liquid supplement
|
Liquid supplement that provides 12.5% of the subjects total energy requirement.
|
|
Experimental: 2
Participants continue current exercise and take solid supplement
|
Solid supplement that provides 12.5% of the subjects total energy requirement.
|
|
Experimental: 3
Participants continue current sedentary behavior and take liquid supplements
|
Liquid supplement that provides 12.5% of the subjects total energy requirement.
|
|
Experimental: 4
Participants continue current sedentary behavior and take solid supplements
|
Solid supplement that provides 12.5% of the subjects total energy requirement.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Quantify the acute effects of fluid and solid foods on post-prandial (post-meal) appetite and food intake at the next eating occasion in trained and untrained, elderly people.
Periodo de tiempo: 6 weeks
|
6 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Quantify the contribution of selected satiety factors (glucose, insulin, CCK, ghrelin, and GLP-1) and gastrointestinal transit time, to the differential appetitive responses to fluid versus solid foods in trained and untrained, elderly people
Periodo de tiempo: 6 weeks
|
6 weeks
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 0607004184
- NIH R01 AG021911-0102
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