Energy Expenditure and Substrate Utilization During Acute Under- and Over-feeding

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Other: 24-hour energy expenditure

• Registration Number: NCT01740765
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Study Start: 2012-05
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2012-11
• Study First Submitted: 2012-11-18
• Study First Submitted QC: 2012-11-29
• Last Update Submitted: 2012-11-29
• Study First Posted: 2012-12-04
• Last Update Posted: 2012-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 7

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

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Exclusion Criteria

• Smoker
• Heavy exerciser (defined as >150 minutes/week for more than 3 months)
• Abuses alcohol or drugs
• Vegetarian

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Eucaloric Feeding	24-hour energy expenditure	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.
Underfeeding	24-hour energy expenditure	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.
Overfeeding	24-hour energy expenditure	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.

Primary Outcome Measures

Name	Time	Method
Energy Expenditure	24-hour energy expenditure will be assessed	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.

Secondary Outcome Measures

Name	Time	Method
Whole blood transcriptomics	Fasting a.m. sample, before lunch, and at 0.5, 2, and 4.5 hours post lunch	RNA will be extracted from whole blood. Transcriptomic profile will be assessed by microarray
Plasma metabolomics	Fasting a.m. sample, before lunch, and at 0.5, 2, and 4.5 hours post lunch	Plasma metabolomic profile will be assessed using GC/MS and LC/MS platforms.

Trial Locations

Locations (1)

UNC Chapel Hill Nutrition Research Institute; 🇺🇸 Kannapolis, North Carolina, United States