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

NCT01740765 | Completed

• 1 other identifier: 12-0681
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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).

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Energy Expenditure

  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 Outcomes (2)

• Whole blood transcriptomics

  Fasting a.m. sample, before lunch, and at 0.5, 2, and 4.5 hours post lunch

• Plasma metabolomics

  Fasting a.m. sample, before lunch, and at 0.5, 2, and 4.5 hours post lunch

Study Arms (3)

Eucaloric Feeding

EXPERIMENTAL

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

Underfeeding

EXPERIMENTAL

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

Overfeeding

EXPERIMENTAL

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

Interventions

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).

Eucaloric Feeding; Overfeeding; Underfeeding

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

UNC Chapel Hill Nutrition Research Institute

Kannapolis, North Carolina, 28081, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Energy Metabolism

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Metabolism

Study Officials

• Andrew G Swick, PhD

  UNC Chapel Hill Nutrition Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2012
• First Posted: December 4, 2012
• Study Start: May 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: December 4, 2012

Record last verified: 2012-11

Locations

US (1)