- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00798668
The Body's Response to Food Intake in Trained, Older Adults
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Indiana
-
West Lafayette, Indiana, États-Unis, 47907
- Purdue University
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: 1
participants continue current exercise and take liquid supplement
|
Liquid supplement that provides 12.5% of the subjects total energy requirement.
|
Expérimental: 2
Participants continue current exercise and take solid supplement
|
Solid supplement that provides 12.5% of the subjects total energy requirement.
|
Expérimental: 3
Participants continue current sedentary behavior and take liquid supplements
|
Liquid supplement that provides 12.5% of the subjects total energy requirement.
|
Expérimental: 4
Participants continue current sedentary behavior and take solid supplements
|
Solid supplement that provides 12.5% of the subjects total energy requirement.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
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.
Délai: 6 weeks
|
6 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
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
Délai: 6 weeks
|
6 weeks
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 0607004184
- NIH R01 AG021911-0102
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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