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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01740765
Enrollment
7
Registered
2012-12-04
Start date
2012-05-31
Completion date
2012-10-31
Last updated
2012-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

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.

Interventions

OTHER24-hour energy expenditure

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).

Sponsors

University of North Carolina, Chapel Hill
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
50 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Energy Expenditure24-hour energy expenditure will be assessed24-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

MeasureTime frameDescription
Whole blood transcriptomicsFasting a.m. sample, before lunch, and at 0.5, 2, and 4.5 hours post lunchRNA will be extracted from whole blood. Transcriptomic profile will be assessed by microarray
Plasma metabolomicsFasting a.m. sample, before lunch, and at 0.5, 2, and 4.5 hours post lunchPlasma metabolomic profile will be assessed using GC/MS and LC/MS platforms.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026