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

NCT ID: NCT01740765

Last Updated: 2012-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2012-10-31

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

24-hour energy expenditure

Intervention Type: 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).

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.

Group Type: EXPERIMENTAL

24-hour energy expenditure

Intervention Type: 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).

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.

Group Type: EXPERIMENTAL

24-hour energy expenditure

Intervention Type: 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).

Interventions

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).

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew G Swick, PhD

Role: PRINCIPAL_INVESTIGATOR

UNC Chapel Hill Nutrition Research Institute

Locations

UNC Chapel Hill Nutrition Research Institute

Kannapolis, North Carolina, United States

Countries

United States

Other Identifiers

12-0681

Identifier Type: -

Identifier Source: org_study_id