SubsTRate OxidatioN in Girls
STRONG
Race Differences in 24-hour Energy Expenditure, Substrate Oxidation, and Appetite in Adolescent Girls
1 other identifier
interventional
14
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 14, 2020
CompletedStudy Start
First participant enrolled
July 15, 2020
CompletedFirst Posted
Study publicly available on registry
July 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 2, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 20, 2023
CompletedApril 2, 2024
April 1, 2024
3.1 years
July 14, 2020
April 1, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Exercise Day Energy expenditure
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
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
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
Non-protein respiratory quotient (i.e., carbohydrate and fat utilization) as measured by the metabolic chamber
24 hours on Sedentary Day
Secondary Outcomes (4)
Exercise Day Appetite
24 hours on Exercise Day
Sedentary Day Appetite
24 hours on Sedentary Day
Exercise Day Energy Intake
24 hours on Exercise Day
Sedentary Day Energy Intake
24 hours on Sedentary Day
Other Outcomes (8)
Dual-energy x-ray absorptiometry (DXA)
Baseline screening visit
Body shape
Baseline screening visit
Cardiorespiratory fitness
Baseline screening visit
- +5 more other outcomes
Study Arms (2)
Exercise
EXPERIMENTALParticipants will complete a prescribed exercise bout.
Sedentary
NO INTERVENTIONParticipants will rest quietly in a seated position for the equivalent amount of time prescribed for the exercise condition.
Interventions
Participants will complete a morning exercise bout at 70% of their individual maximal aerobic capacity to burn 200 kilocalories above their basal metabolic rate.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Ravussin, PhD
Professor
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 14, 2020
First Posted
July 23, 2020
Study Start
July 15, 2020
Primary Completion
September 2, 2023
Study Completion
October 20, 2023
Last Updated
April 2, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share
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.