Pediatric ObesityNCT02484612
Exercise Intensity and Appetite in Adolescents
A study testing acute exercise in people with Pediatric Obesity, run by Université Blaise Pascal, Clermont-Ferrand.
Trial summary
Acute exercise has been shown to affect subsequent energy intake in obese adolescents. Indeed, it has been shown several times that an intensive bout of exercise (above 70% of the individual maximal capacities) can reduce energy intake at the following meal in obese adolescents, with no modification of his appetite… Read more about this study
- Who is it for?
- Ages 12 to 15 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- acute exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Dec 2017
- 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 12 to 15 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- 12 to 15 years old adolescents
- Obese according to international values for BMI
- Being registered to the national social security insurance
- no eating disorders
- no medications
- metabolic disorders
Who cannot join
- metabolic disorders
- food disorders
- physical disability
About this study
Official title: Effect of Acute Exercise Intensity on Energy Intake in Adolescents: Effect of Weight Status
Acute exercise has been shown to affect subsequent energy intake in obese adolescents. Indeed, it has been shown several times that an intensive bout of exercise (above 70% of the individual maximal capacities) can reduce energy intake at the following meal in obese adolescents, with no modification of his appetite feelings.
Although this results has been replicated several times, it remains unknown if those nutritional adaptations are due to post-exercise modifications of some gastro-peptides implicated in appetite control, as detailed in adults.
The aim of this work is to question whether or not post-exercise energy intake is explained by appetite-regulating hormones that are affected by the exercise bout in both lean and obese youth.
Read the detailed description
After an first medical visit to ensure that the adolescents have the ability to complete the whole study, the participants will have to complete several clinical examinations:
- anthropometric measurements
- Body composition assessed by dual energy x-ray absorptiometry
- Maximal aerobic test
They will then randomly complete the following conditions:
- CON: a control day without exercise;
- HIE: an exercise day with an exercise set at 75% of the capacities
- LIE: an exercise day with an exercise set at 40% of the capacities
The exercises or the rest condition will be done by the end of the morning and a buffet meal will be proposed during which the participants will be asked to eat as much as wanted.
Blood samples will be drawn before, after, 15 after and 30 minutes after the exercise to assess the main appetite regulating hormones involved in appetite regulation (PYY, Cholecystokinin ...) appetite feelings will be assessed throughout the day at regular interval using visual analogue scales.
- Conditions
- Pediatric Obesity
- Being tested
- acute exercise
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acute exerciseBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Lean adolescents | Experimental | 15 lean adolescents (BMI Under the national cut-offs for obesity), 12-15 years old, males, will be recruited Receives: Behavioral: acute exercise |
| Obese adolescents | Experimental | 15 obese adolescents (BMI above the national cut-offs for obesity), 12-15 years old, males, will be recruited Receives: Behavioral: acute exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
energy intake in kcal
buffet meal
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2015 (estimated)
- Study startSep 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ObesityStudies 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Blaise Pascal, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, THIVEL David, Université Blaise Pascal, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02484612
- Sponsor's protocol ID
- AME2P Laboratory
- Status last verified
- May 2016
- First submitted
- 19 Jun 2015
- Last updated
- 11 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acute Exercise Intensity on Energy Intake in Adolescents: Effect of Weight Status
- ClinicalTrials.gov ID
- NCT02484612
- Acronym / sponsor ID
- AME2P Laboratory
- Conditions
- Pediatric Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Université Blaise Pascal, Clermont-FerrandUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 29 Jun 2015 (estimated)
- 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.
Acute exercise has been shown to affect subsequent energy intake in obese adolescents. Indeed, it has been shown several times that an intensive bout of exercise (above 70% of the individual maximal capacities) can reduce energy intake at the following meal in obese adolescents, with no modification of his appetite feelings.
Although this results has been replicated several times, it remains unknown if those nutritional adaptations are due to post-exercise modifications of some gastro-peptides implicated in appetite control, as detailed in adults.
The aim of this work is to question whether or not post-exercise energy intake is explained by appetite-regulating hormones that are affected by the exercise bout in both lean and obese youth.
Detailed description
After an first medical visit to ensure that the adolescents have the ability to complete the whole study, the participants will have to complete several clinical examinations:
- anthropometric measurements
- Body composition assessed by dual energy x-ray absorptiometry
- Maximal aerobic test
They will then randomly complete the following conditions:
- CON: a control day without exercise;
- HIE: an exercise day with an exercise set at 75% of the capacities
- LIE: an exercise day with an exercise set at 40% of the capacities
The exercises or the rest condition will be done by the end of the morning and a buffet meal will be proposed during which the participants will be asked to eat as much as wanted.
Blood samples will be drawn before, after, 15 after and 30 minutes after the exercise to assess the main appetite regulating hormones involved in appetite regulation (PYY, Cholecystokinin ...) appetite feelings will be assessed throughout the day at regular interval using visual analogue scales.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lean adolescents | Experimental | Behavioral: acute exercise15 lean adolescents (BMI Under the national cut-offs for obesity), 12-15 years old, males, will be recruited |
| Obese adolescents | Experimental | Behavioral: acute exercise15 obese adolescents (BMI above the national cut-offs for obesity), 12-15 years old, males, will be recruited |
Who may qualify
- Ages
- 12 to 15 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 12 to 15 years old adolescents
- Obese according to international values for BMI
- Being registered to the national social security insurance
- no eating disorders
- no medications
Key exclusion criteria (3 listed)
- metabolic disorders
- food disorders
- physical disability
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 exercise | Behavioural | Lean adolescents, Obese adolescents |
Primary outcome
energy intake in kcal
Time frame: up to 2 months
buffet meal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing acute exercise in people with Pediatric Obesity, run by Université Blaise Pascal, Clermont-Ferrand.
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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 11 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
energy intake in kcal (time frame: up to 2 months). 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 11 May 2016.