Energy Expenditure and Substrate Utilization During Acute Under- and Over-feeding
29 novembre 2012 mis à jour par: University of North Carolina, Chapel Hill
This study will determine the impact of 24, 48 and 72 hours of over and underfeeding on energy expenditure as measured in the metabolic chamber at the UNC Chapel Hill Nutrition Research Institute (UNC NRI).
Aperçu de l'étude
Description détaillée
Subjects will complete a baseline eucaloric study day.
Following this, subjects will be randomized to complete 3 days of overfeeding (150% of baseline eucaloric energy requirements) or 3 days of underfeeding (50% of baseline eucaloric energy requirements).
After completing one of these study arms, subjects will cross-over and complete the second arm.
All study arms will be separated by two weeks.
24-hour energy expenditure will be measured 3 times during each of 3 day periods.
We hypothesize that the impact of over or underfeeding on EE will be evident after 24-hours and will be comparable to 72 hour EE.
Type d'étude
Interventionnel
Inscription (Réel)
7
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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North Carolina
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Kannapolis, North Carolina, États-Unis, 28081
- UNC Chapel Hill Nutrition Research Institute
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
50 ans à 65 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Femelle
La description
Inclusion Criteria:
- Woman
- Postmenopausal
- Aged 50-65 years
- BMI 25-35kg/m2
- Not taking blood pressure or anti-inflammatory medications or any other medications that may impact the results
- Thyroid hormone profile within the normal reference range
- No medical condition which may impact the results (e.g. diabetes)
- Accustomed to eating regular meals including breakfast
Exclusion Criteria:
- Smoker
- Heavy exerciser (defined as >150 minutes/week for more than 3 months)
- Abuses alcohol or drugs
- Vegetarian
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Eucaloric Feeding
Subjects will complete an initial eucaloric feeding study day.
During this study day, subjects will receive 100% of their calorie requirements.
24-hour energy expenditure will be measured.
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To assess 24-hour energy expenditure and substrate utilization subjects will spend 23 hours and 15 minutes each day in the metabolic chamber at the UNC NRI.
Subjects will be requested to arrive at the study center each morning following a 10hour overnight fast.
During each study day, subjects remained sedentary.
All meals were provided and were tailored to each subject's specific energy requirements and the study protocol (i.e.
50% or 150% of calorie requirements).
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Expérimental: Underfeeding
Following the eucaloric feeding study day, subjects will undergo the underfeeding and overfeeding arms in random order.
During the underfeeding study arm, subjects will receive 50% of their calorie requirements (as determined during the initial eucaloric study day) for 3 days.
24-hour energy expenditure will be measured.
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To assess 24-hour energy expenditure and substrate utilization subjects will spend 23 hours and 15 minutes each day in the metabolic chamber at the UNC NRI.
Subjects will be requested to arrive at the study center each morning following a 10hour overnight fast.
During each study day, subjects remained sedentary.
All meals were provided and were tailored to each subject's specific energy requirements and the study protocol (i.e.
50% or 150% of calorie requirements).
|
|
Expérimental: Overfeeding
Following the eucaloric feeding study day, subjects will undergo the underfeeding and overfeeding arms in random order.
During the overfeeding study arm, subjects will receive 150% of their calorie requirements (as determined during the initial eucaloric study day) for 3 days.
24-hour energy expenditure will be measured.
|
To assess 24-hour energy expenditure and substrate utilization subjects will spend 23 hours and 15 minutes each day in the metabolic chamber at the UNC NRI.
Subjects will be requested to arrive at the study center each morning following a 10hour overnight fast.
During each study day, subjects remained sedentary.
All meals were provided and were tailored to each subject's specific energy requirements and the study protocol (i.e.
50% or 150% of calorie requirements).
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Energy Expenditure
Délai: 24-hour energy expenditure will be assessed
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24-hour energy expenditure will be assessed using the metabolic chamber at UNC NRI.
Energy expenditure will be measured during eucaloric feeding (subjects will receive 100% of calorie requirements), as well as during 24, 48 and 72 hours of under and overfeeding.
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24-hour energy expenditure will be assessed
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Whole blood transcriptomics
Délai: Fasting a.m. sample, before lunch, and at 0.5, 2, and 4.5 hours post lunch
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RNA will be extracted from whole blood.
Transcriptomic profile will be assessed by microarray
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Fasting a.m. sample, before lunch, and at 0.5, 2, and 4.5 hours post lunch
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Plasma metabolomics
Délai: Fasting a.m. sample, before lunch, and at 0.5, 2, and 4.5 hours post lunch
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Plasma metabolomic profile will be assessed using GC/MS and LC/MS platforms.
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Fasting a.m. sample, before lunch, and at 0.5, 2, and 4.5 hours post lunch
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Les enquêteurs
- Chercheur principal: Andrew G Swick, PhD, UNC Chapel Hill Nutrition Research Institute
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 mai 2012
Achèvement primaire (Réel)
1 octobre 2012
Achèvement de l'étude (Réel)
1 octobre 2012
Dates d'inscription aux études
Première soumission
18 novembre 2012
Première soumission répondant aux critères de contrôle qualité
29 novembre 2012
Première publication (Estimation)
4 décembre 2012
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
4 décembre 2012
Dernière mise à jour soumise répondant aux critères de contrôle qualité
29 novembre 2012
Dernière vérification
1 novembre 2012
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 12-0681
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 .