Exercise Condition (EX)NCT02100878
Exercise and Neural Response to Food Cues in Children
An observational study of Exercise Condition (EX) and Control Session (CON), run by Université Blaise Pascal, Clermont-Ferrand at 1 site in France.
Trial summary
Physical exercise has been shown to significantly reduce subsequent energy intake in obese adolescents but not in lean, without altering their appetite feelings. Although previous studies have pointed out the role of gastric peptides in this post exercise nutritional response, some recent work question the role of the… 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
- Exercise Condition (EX), Control Session (CON)
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2014to Mar 2015
- Phase
- Observational
- 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
Study population: Lean and obese adolescents will be recruited accodring to the international curves for obesity. they will be between 12 to 15 years old and will have no medical limitations to complete exercise testings.
Who may be able to join
- male
- 12-15 years old
- BMI defining obesity (Cole et al., 2000)
- Not being under diet restriction
- Information and consent forms have to be signed by the adolescent and his legal representative
- being registered to the national social security system
Who cannot join
- Being under medication
- contraindication to exercise
- smokers
- dieting
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Exercise on the Neural Response to Food Cues and Energy Intake in Lean and Obese Adolescents
Physical exercise has been shown to significantly reduce subsequent energy intake in obese adolescents but not in lean, without altering their appetite feelings. Although previous studies have pointed out the role of gastric peptides in this post exercise nutritional response, some recent work question the role of the neural system in the post exercise drive to eat. This study tends to explore whether or not an acute bout of exercise can affect the neural response to food cues in adolescents, obese or lean.
Read the detailed description
After a medical inclusion, the adolescents will have to realise a DXA to assess their body composition and a submaximal exercise to evaluate their aerobic capacities.
They will have then to enter the laboratory on 2 different occasions in a randomized order from 8am to 330pm: At 8am they will receive a calibrated breakfast. then, at 1045; they will have to complete one of the experimental condition: 1) a cycling exercise or 2) remaining sitting fpr one hour. after the one hour sitting station or the exercise bout, they will be asked to complete a computer task while and electroencephalogram will be recorded. This computer task consists in visual recognition of rare pictures compared to frequent ones (oddball method). at 1215 they will be offered ad libitum meals. At regular intervals through the day, their appetite feelings will be assessed using Visual analogue scales.
Ad libitum energy consumption will be assessed by investigators and recorded for each participants.
- Conditions
- Exercise Condition (EX), Control Session (CON)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lean adolescents | Not described | |
| Obese adolescents | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neural response to food cues
The electroencephalogram signals amplitude in response to visual food cues will be the primary outcome, after the exercise (during the exercise condition) and after the sitting position (during the control session)
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 posted1 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionMar 2014
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise Condition (EX)Studies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
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
- NCT02100878
- Sponsor's protocol ID
- AU1107
- Status last verified
- Apr 2014
- First submitted
- 27 Mar 2014
- Last updated
- 2 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exercise on the Neural Response to Food Cues and Energy Intake in Lean and Obese Adolescents
- ClinicalTrials.gov ID
- NCT02100878
- Acronym / sponsor ID
- AU1107
- Conditions
- Exercise Condition (EX), Control Session (CON)
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Université Blaise Pascal, Clermont-FerrandUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2015 (estimated)
- First posted
- 1 Apr 2014 (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.
Physical exercise has been shown to significantly reduce subsequent energy intake in obese adolescents but not in lean, without altering their appetite feelings. Although previous studies have pointed out the role of gastric peptides in this post exercise nutritional response, some recent work question the role of the neural system in the post exercise drive to eat. This study tends to explore whether or not an acute bout of exercise can affect the neural response to food cues in adolescents, obese or lean.
Detailed description
After a medical inclusion, the adolescents will have to realise a DXA to assess their body composition and a submaximal exercise to evaluate their aerobic capacities.
They will have then to enter the laboratory on 2 different occasions in a randomized order from 8am to 330pm: At 8am they will receive a calibrated breakfast. then, at 1045; they will have to complete one of the experimental condition: 1) a cycling exercise or 2) remaining sitting fpr one hour. after the one hour sitting station or the exercise bout, they will be asked to complete a computer task while and electroencephalogram will be recorded. This computer task consists in visual recognition of rare pictures compared to frequent ones (oddball method). at 1215 they will be offered ad libitum meals. At regular intervals through the day, their appetite feelings will be assessed using Visual analogue scales.
Ad libitum energy consumption will be assessed by investigators and recorded for each participants.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lean adolescents | – | – |
| Obese adolescents | – | – |
Who may qualify
- Ages
- 12 to 15 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Lean and obese adolescents will be recruited accodring to the international curves for obesity. they will be between 12 to 15 years old and will have no medical limitations to complete exercise testings.
Key inclusion criteria (6 listed)
- male
- 12-15 years old
- BMI defining obesity (Cole et al., 2000)
- Not being under diet restriction
- Information and consent forms have to be signed by the adolescent and his legal representative
Key exclusion criteria (4 listed)
- Being under medication
- contraindication to exercise
- smokers
- dieting
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Neural response to food cues
Time frame: up to 2 months
The electroencephalogram signals amplitude in response to visual food cues will be the primary outcome, after the exercise (during the exercise condition) and after the sitting position (during the control session)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Exercise Condition (EX) and Control Session (CON), run by Université Blaise Pascal, Clermont-Ferrand at 1 site in France.
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 4 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: withdrawn, as of the sponsor's last update on 2 Apr 2014. 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 France. 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 was withdrawn before enrolling participants, so there are no results.
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?
Neural response to food cues (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 2 Apr 2014.