- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01740765
Energy Expenditure and Substrate Utilization During Acute Under- and Over-feeding
November 29, 2012 updated by: 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).
Study Overview
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 Type
Interventional
Enrollment (Actual)
7
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Kannapolis, North Carolina, United States, 28081
- UNC Chapel Hill Nutrition Research Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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).
|
|
Experimental: 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.
|
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).
|
|
Experimental: 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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Energy Expenditure
Time Frame: 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.
|
24-hour energy expenditure will be assessed
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Whole blood transcriptomics
Time Frame: 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
|
Fasting a.m. sample, before lunch, and at 0.5, 2, and 4.5 hours post lunch
|
|
Plasma metabolomics
Time Frame: 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.
|
Fasting a.m. sample, before lunch, and at 0.5, 2, and 4.5 hours post lunch
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Andrew G Swick, PhD, UNC Chapel Hill Nutrition Research Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2012
Primary Completion (Actual)
October 1, 2012
Study Completion (Actual)
October 1, 2012
Study Registration Dates
First Submitted
November 18, 2012
First Submitted That Met QC Criteria
November 29, 2012
First Posted (Estimate)
December 4, 2012
Study Record Updates
Last Update Posted (Estimate)
December 4, 2012
Last Update Submitted That Met QC Criteria
November 29, 2012
Last Verified
November 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- 12-0681
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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