Overweight AdolescentsSTRONGNCT04483921
SubsTRate OxidatioN in Girls
A study testing Acute exercise in people with Overweight Adolescents, run by Pennington Biomedical Research Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 17 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight Adolescents
- What is being tested?
- Acute exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2020to 20 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: 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.
Read the 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.
- Conditions
- Overweight Adolescents
- Being tested
- Acute exercise
- Keywords
- Energy expenditure, Substrate oxidation, Appetite, Exercise, Energy intake
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute exerciseOther
Participants will complete a morning exercise bout at 70% of their individual maximal aerobic capacity to burn 200 kilocalories above their basal metabolic rate.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Participants will complete a prescribed exercise bout. Receives: Other: Acute exercise |
| Sedentary | No intervention | Participants will rest quietly in a seated position for the equivalent amount of time prescribed for the exercise condition. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Day Energy expenditure
Total energy expenditure and its components (sleeping, wake [non-exercise], activity) as measured by the metabolic chamber
Measured: 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
Measured: 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
Measured: 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
Measured: 24 hours on Sedentary Day
Secondary outcomes (4)
Exercise Day Appetite
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
Measured: 24 hours on Exercise Day
Sedentary Day Appetite
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
Measured: 24 hours on Sedentary Day
Exercise Day Energy Intake
Objectively measured food intake during the metabolic chamber assessments will be converted to energy intake in kilocalories
Measured: 24 hours on Exercise Day
Sedentary Day Energy Intake
Objectively measured food intake during the metabolic chamber assessments will be converted to energy intake in kilocalories
Measured: 24 hours on Sedentary Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start15 Jul 2020
- Primary completion2 Sep 2023
- Study completion20 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight AdolescentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Within-subjects crossover design. The order of conditions is counterbalanced within each subgroup of participants.
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Nutrition Obesity Research Center
- Responsible party
- Principal investigator, Eric Ravussin, Pennington Biomedical Research Center
- Investigators
- Eric Ravussin, PhD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04483921
- Sponsor's protocol ID
- PBRC 2020-003
- Acronym
- STRONG
- Status last verified
- Apr 2024
- First submitted
- 14 Jul 2020
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Race Differences in 24-hour Energy Expenditure, Substrate Oxidation, and Appetite in Adolescent Girls
- ClinicalTrials.gov ID
- NCT04483921
- Acronym / sponsor ID
- STRONG / PBRC 2020-003
- Conditions
- Overweight Adolescents
- Keywords
- Energy expenditure, Substrate oxidation, Appetite, Exercise, Energy intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- Nutrition Obesity Research Center
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 2 Sep 2023 (actual)
- Study completion
- 20 Oct 2023 (actual)
- First posted
- 23 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Within-subjects crossover design. The order of conditions is counterbalanced within each subgroup of participants.
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: Acute exerciseParticipants will complete a prescribed exercise bout. |
| Sedentary | No intervention | –Participants will rest quietly in a seated position for the equivalent amount of time prescribed for the exercise condition. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acute exerciseParticipants will complete a morning exercise bout at 70% of their individual maximal aerobic capacity to burn 200 kilocalories above their basal metabolic rate. | Other | Exercise |
Primary outcome
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
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
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
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
4 secondary outcomes
Exercise Day Appetite
Time frame: 24 hours on Exercise Day
Sedentary Day Appetite
Time frame: 24 hours on Sedentary Day
Exercise Day Energy Intake
Time frame: 24 hours on Exercise Day
Sedentary Day Energy Intake
Time frame: 24 hours on Sedentary Day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Ravussin, PhD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute exercise in people with Overweight Adolescents, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise Day Energy expenditure (time frame: 24 hours on Exercise Day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024; AzTrials last refreshed its copy on 29 Oct 2026.