SubsTRate OxidatioN in Girls (STRONG)

April 1, 2024 updated by: Eric Ravussin, Pennington Biomedical Research Center

Race Differences in 24-hour Energy Expenditure, Substrate Oxidation, and Appetite in Adolescent Girls

This study will examine race differences in total energy expenditure and respiratory quotient (RQ) during and after exercise, compared to a sedentary control condition, in adolescent girls who are classified as overweight. In addition, subjective appetite and objective energy intake will be measured throughout the assessment periods.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Aim 1: Measure 24-hour energy expenditure and its components (resting, activity, and sleep energy expenditure) and compare differences between African-American and White girls.

Hypothesis: Total, resting, and sleep energy expenditure will be lower in African-American relative to White girls. Activity energy expenditure will be equivalent per the study design.

Aim 2: Measure and compare substrate oxidation and associations with appetite (i.e., hunger, desire to eat) and energy intake between African-American and White girls.

Hypothesis: African-American girls will have a higher RQ at rest, during exercise, and following exercise, and RQ will be positively associated with subjective appetite ratings and energy intake.

Study Type

Interventional

Enrollment (Actual)

14

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

    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pennington Biomedical Research Center

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

13 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Female
  • Age 13-17 years, inclusive
  • Achieved menarche based on parent- and/or self-report
  • Overweight based on BMI percentile for age and sex (≥ 85th and < 95th)
  • Self-identification as non-Hispanic White or African-American
  • Willing to maintain current physical activity, sleep schedule, and dietary habits during the study
  • Willing to comply with study procedures

Exclusion Criteria:

  • Contraindications to exercise testing as defined by the American College of Sports Medicine (i.e., medical history of cardiovascular, pulmonary, or physical conditions that affect the ability to exercise)
  • Food allergies
  • Dietary restrictions
  • Unwilling to consume study foods
  • History of polycystic ovary syndrome (PCOS)
  • Current amenorrhea or other menstrual cycle irregularities
  • Pregnant or currently breastfeeding
  • Current anemia
  • Use of medications affecting metabolism or sleep
  • Inability to properly or safely complete the study procedures per the investigators' discretion

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: Exercise
Participants will complete a prescribed exercise bout.
Participants will complete a morning exercise bout at 70% of their individual maximal aerobic capacity to burn 200 kilocalories above their basal metabolic rate.
No Intervention: Sedentary
Participants will rest quietly in a seated position for the equivalent amount of time prescribed for the exercise condition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exercise Day Energy expenditure
Time Frame: 24 hours on Exercise Day
Total energy expenditure and its components (sleeping, wake [non-exercise], activity) as measured by the metabolic chamber
24 hours on Exercise Day
Sedentary Day Energy expenditure
Time Frame: 24 hours on Sedentary Day
Total energy expenditure and its components (sleeping, wake [non-exercise], activity) as measured by the metabolic chamber
24 hours on Sedentary Day
Exercise Day Substrate oxidation
Time Frame: 24 hours on Exercise Day
Non-protein respiratory quotient (i.e., carbohydrate and fat utilization) as measured by the metabolic chamber
24 hours on Exercise Day
Sedentary Day Substrate oxidation
Time Frame: 24 hours on Sedentary Day
Non-protein respiratory quotient (i.e., carbohydrate and fat utilization) as measured by the metabolic chamber
24 hours on Sedentary Day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exercise Day Appetite
Time Frame: 24 hours on Exercise Day
Overall subjective appetite and its components (hunger, fullness, desire to eat, prospective food consumption, satisfaction, food wanting) assessed by visual analog scales (0-100 mm) during the metabolic chamber assessments
24 hours on Exercise Day
Sedentary Day Appetite
Time Frame: 24 hours on Sedentary Day
Overall subjective appetite and its components (hunger, fullness, desire to eat, prospective food consumption, satisfaction, food wanting) assessed by visual analog scales (0-100 mm) during the metabolic chamber assessments
24 hours on Sedentary Day
Exercise Day Energy Intake
Time Frame: 24 hours on Exercise Day
Objectively measured food intake during the metabolic chamber assessments will be converted to energy intake in kilocalories
24 hours on Exercise Day
Sedentary Day Energy Intake
Time Frame: 24 hours on Sedentary Day
Objectively measured food intake during the metabolic chamber assessments will be converted to energy intake in kilocalories
24 hours on Sedentary Day

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dual-energy x-ray absorptiometry (DXA)
Time Frame: Baseline screening visit
Total body composition (fat, muscle, bone tissue) measured by Hologic Discovery DXA
Baseline screening visit
Body shape
Time Frame: Baseline screening visit
3D optical imaging assessment of body shape by Fit3D scanner
Baseline screening visit
Cardiorespiratory fitness
Time Frame: Baseline screening visit
Maximal aerobic capacity assessed by graded cycle ergometer test to volitional fatigue
Baseline screening visit
Resting metabolic rate
Time Frame: Baseline screening visit
Measured over a 30-minute period by ventilated hood and metabolic cart
Baseline screening visit
Implicit activity preferences
Time Frame: Baseline screening visit
Relative preference for physical versus sedentary activities as assessed by a forced-choice behavioral task
Baseline screening visit
Habitual physical activity
Time Frame: 7 days leading up to Exercise Day and Sedentary Day
Accelerometry measures of usual physical activity before each experimental visit
7 days leading up to Exercise Day and Sedentary Day
Habitual sedentary time
Time Frame: 7 days leading up to Exercise Day and Sedentary Day
Accelerometry measures of usual sedentary time before each experimental visit
7 days leading up to Exercise Day and Sedentary Day
Habitual food intake
Time Frame: 3 days leading up to Exercise Day and Sedentary Day
Food intake diary/dietary record to assist participants in maintaining consistent diet before each experimental visit
3 days leading up to Exercise Day and Sedentary Day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Eric Ravussin, PhD, Professor

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 (Actual)

July 15, 2020

Primary Completion (Actual)

September 2, 2023

Study Completion (Actual)

October 20, 2023

Study Registration Dates

First Submitted

July 14, 2020

First Submitted That Met QC Criteria

July 20, 2020

First Posted (Actual)

July 23, 2020

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PBRC 2020-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

De-identified IPD will be housed indefinitely on secure digital servers as part of the Pennington Biomedical Clinical Database. De-identified IPD may be made available to other researchers upon reasonable request to the Principal Investigator, following Pennington Biomedical's standard procedures for data use agreements and secure data transfers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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