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

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ClinicalTrials.gov Identifier: NCT01740765
Recruitment Status : Completed
First Posted : December 4, 2012
Last Update Posted : December 4, 2012
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Obesity Other: 24-hour energy expenditure Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Energy Expenditure and Substrate Utilization During Acute Under- and Over-feeding
Study Start Date : May 2012
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

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.
Other: 24-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).

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.
Other: 24-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).

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.
Other: 24-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).




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.



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Ages Eligible for Study:   50 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01740765


Locations
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United States, North Carolina
UNC Chapel Hill Nutrition Research Institute
Kannapolis, North Carolina, United States, 28081
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
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Principal Investigator: Andrew G Swick, PhD UNC Chapel Hill Nutrition Research Institute
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01740765    
Other Study ID Numbers: 12-0681
First Posted: December 4, 2012    Key Record Dates
Last Update Posted: December 4, 2012
Last Verified: November 2012