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NCT Number: NCT01740765

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

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).

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

50 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UNC Chapel Hill Nutrition Research Institute

Kannapolis, North Carolina, 28081, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

24-hour energy expenditure

Other

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Dec 4, 2012
Registry last updated
Dec 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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