- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04483921
SubsTRate OxidatioN in Girls (STRONG)
Race Differences in 24-hour Energy Expenditure, Substrate Oxidation, and Appetite in Adolescent Girls
Study Overview
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Louisiana
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Baton Rouge, Louisiana, United States, 70808
- Pennington Biomedical Research Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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 |
|---|---|
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Experimental: Exercise
Participants will complete a prescribed exercise bout.
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Participants will complete a morning exercise bout at 70% of their individual maximal aerobic capacity to burn 200 kilocalories above their basal metabolic rate.
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No Intervention: Sedentary
Participants will rest quietly in a seated position for the equivalent amount of time prescribed for the exercise condition.
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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
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Total energy expenditure and its components (sleeping, wake [non-exercise], activity) as measured by the metabolic chamber
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24 hours on Exercise Day
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Sedentary Day Energy expenditure
Time Frame: 24 hours on Sedentary Day
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Total energy expenditure and its components (sleeping, wake [non-exercise], activity) as measured by the metabolic chamber
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24 hours on Sedentary Day
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Exercise Day Substrate oxidation
Time Frame: 24 hours on Exercise Day
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Non-protein respiratory quotient (i.e., carbohydrate and fat utilization) as measured by the metabolic chamber
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24 hours on Exercise Day
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Sedentary Day Substrate oxidation
Time Frame: 24 hours on Sedentary Day
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Non-protein respiratory quotient (i.e., carbohydrate and fat utilization) as measured by the metabolic chamber
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24 hours on Sedentary Day
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Exercise Day Appetite
Time Frame: 24 hours on Exercise Day
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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
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24 hours on Exercise Day
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Sedentary Day Appetite
Time Frame: 24 hours on Sedentary Day
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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
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24 hours on Sedentary Day
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Exercise Day Energy Intake
Time Frame: 24 hours on Exercise Day
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Objectively measured food intake during the metabolic chamber assessments will be converted to energy intake in kilocalories
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24 hours on Exercise Day
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Sedentary Day Energy Intake
Time Frame: 24 hours on Sedentary Day
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Objectively measured food intake during the metabolic chamber assessments will be converted to energy intake in kilocalories
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24 hours on Sedentary Day
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Dual-energy x-ray absorptiometry (DXA)
Time Frame: Baseline screening visit
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Total body composition (fat, muscle, bone tissue) measured by Hologic Discovery DXA
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Baseline screening visit
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Body shape
Time Frame: Baseline screening visit
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3D optical imaging assessment of body shape by Fit3D scanner
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Baseline screening visit
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Cardiorespiratory fitness
Time Frame: Baseline screening visit
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Maximal aerobic capacity assessed by graded cycle ergometer test to volitional fatigue
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Baseline screening visit
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Resting metabolic rate
Time Frame: Baseline screening visit
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Measured over a 30-minute period by ventilated hood and metabolic cart
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Baseline screening visit
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Implicit activity preferences
Time Frame: Baseline screening visit
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Relative preference for physical versus sedentary activities as assessed by a forced-choice behavioral task
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Baseline screening visit
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Habitual physical activity
Time Frame: 7 days leading up to Exercise Day and Sedentary Day
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Accelerometry measures of usual physical activity before each experimental visit
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7 days leading up to Exercise Day and Sedentary Day
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Habitual sedentary time
Time Frame: 7 days leading up to Exercise Day and Sedentary Day
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Accelerometry measures of usual sedentary time before each experimental visit
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7 days leading up to Exercise Day and Sedentary Day
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Habitual food intake
Time Frame: 3 days leading up to Exercise Day and Sedentary Day
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Food intake diary/dietary record to assist participants in maintaining consistent diet before each experimental visit
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3 days leading up to Exercise Day and Sedentary Day
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Eric Ravussin, PhD, Professor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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