Healthy and Physically Active Young MenAPPANCT02157233
Post-exercise Food Intake Regulation in a Hot Environment
A study testing Rest and Exercise in people with Healthy and Physically Active Young Men, run by University of the French West Indies and French Guiana at 1 site in France.
Trial summary
The potential of physical activity and other non-medicinal methods for the care and prevention of metabolic and cardiovascular disorders has been insufficiently used. There is a potential influence of environmental heat in energetic balance regulation. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy and Physically Active Young Men
- What is being tested?
- Rest and Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2013to Feb 2015
- 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 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy and physically active men aged 18-30 years
Who cannot join
- any physical or medical problem liable to limit the subjects' ability to perform the exercise testing in safe conditions,
- ear troubles
Trial locations and contacts
1 site in 1 country.
About this study
The potential of physical activity and other non-medicinal methods for the care and prevention of metabolic and cardiovascular disorders has been insufficiently used. There is a potential influence of environmental heat in energetic balance regulation. However, the existing knowledge is insufficient to optimize physical activity programs based on the impact of exercise on energy intake regulation in hot climates. The aim of the present study is to define the major physiological determinants of short-term food intake regulation in young active and healthy men, when exposed to different levels of metabolic activity and environmental temperatures. We will thus explore the biological mechanisms related to post-exercise relative energy intake. Post-rest and post-exercise energetic compensation will be analysed in these different environmental conditions, with a special focus on the effect of the birth weight. This study should open interesting ways to define adequate nutritional and exercising programs in hot environments.
- Conditions
- Healthy and Physically Active Young Men
- Being tested
- Rest, Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RestBehavioural
ExerciseBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Hot environment | Experimental | Subjects will perform the intervention in a hot environment (33°C) Receives: Behavioral: Rest; Behavioral: Exercise |
| Neutral environment | Sham comparator | Subjects will perform the intervention in a neutral environment (22°C) Receives: Behavioral: Rest; Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative post-exercise and post-rest energy intake
Measured: 11 months
Secondary outcomes (8)
Appetite hormones
insulin, CCK, leptin, ghrelin, pancreatic peptide
Measured: 13 months
Heart rate variability
Measured: 11 months
Tympanic temperature
Measured: 11 months
Peak exercise capacity
Measured: 11 months
Appetite visual analogic scale
Measured: 11 months
metabolic markers
glucose, lipid profile, cortisol
Measured: 13 months
vascular biomarkers
usCRP, inflammatory markers, hemorheological markers
Measured: 13 months
comfort visual scale
Measured: 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2014 (estimated)
- Study startOct 2013
- Primary completionJan 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy and Physically Active Young MenStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the French West Indies and French Guiana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02157233
- Sponsor's protocol ID
- 13/N/01
- Acronym
- APPA
- Status last verified
- Feb 2015
- First submitted
- 2 Jun 2014
- Last updated
- 16 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Faure C, Charlot K, Henri S, Hardy-Dessources MD, Hue O, Antoine-Jonville S. Effect of heat exposure and exercise on food intake regulation: A randomized crossover study in young healthy men. Metabolism. 2016 Oct;65(10):1541-9. doi: 10.1016/j.metabol.2016.07.004. Epub 2016 Jul 11.
PubMed 27621189
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-exercise Food Intake Regulation in a Hot Environment
- ClinicalTrials.gov ID
- NCT02157233
- Acronym / sponsor ID
- APPA / 13/N/01
- Conditions
- Healthy and Physically Active Young Men
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of the French West Indies and French GuianaUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 5 Jun 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.
The potential of physical activity and other non-medicinal methods for the care and prevention of metabolic and cardiovascular disorders has been insufficiently used. There is a potential influence of environmental heat in energetic balance regulation. However, the existing knowledge is insufficient to optimize physical activity programs based on the impact of exercise on energy intake regulation in hot climates. The aim of the present study is to define the major physiological determinants of short-term food intake regulation in young active and healthy men, when exposed to different levels of metabolic activity and environmental temperatures. We will thus explore the biological mechanisms related to post-exercise relative energy intake. Post-rest and post-exercise energetic compensation will be analysed in these different environmental conditions, with a special focus on the effect of the birth weight. This study should open interesting ways to define adequate nutritional and exercising programs in hot environments.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hot environment | Experimental | Behavioral: Rest, Behavioral: ExerciseSubjects will perform the intervention in a hot environment (33°C) |
| Neutral environment | Sham comparator | Behavioral: Rest, Behavioral: ExerciseSubjects will perform the intervention in a neutral environment (22°C) |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy and physically active men aged 18-30 years
Key exclusion criteria (2 listed)
- any physical or medical problem liable to limit the subjects' ability to perform the exercise testing in safe conditions,
- ear troubles
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 |
|---|---|---|
| Rest | Behavioural | Hot environment, Neutral environment |
| Exercise | Behavioural | Hot environment, Neutral environment |
Primary outcome
Relative post-exercise and post-rest energy intake
Time frame: 11 months
8 secondary outcomes
Appetite hormones
Time frame: 13 months
Heart rate variability
Time frame: 11 months
Tympanic temperature
Time frame: 11 months
Peak exercise capacity
Time frame: 11 months
Appetite visual analogic scale
Time frame: 11 months
metabolic markers
Time frame: 13 months
vascular biomarkers
Time frame: 13 months
comfort visual scale
Time frame: 11 months
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 16 Feb 2015.
- Derived from this study: PubMed 27621189Faure C, Charlot K, Henri S, Hardy-Dessources MD, Hue O, Antoine-Jonville S. Effect of heat exposure and exercise on food intake regulation: A randomized crossover study in young healthy men. Metabolism. 2016 Oct;65(10):1541-9. doi: 10.1016/j.metabol.2016.07.004. Epub 2016 Jul 11.
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?
A study testing Rest and Exercise in people with Healthy and Physically Active Young Men, run by University of the French West Indies and French Guiana 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 1 inclusion and 2 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 16 Feb 2015. 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. Some participants in this study may receive a placebo. 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?
Relative post-exercise and post-rest energy intake (time frame: 11 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02157233, which also lists 1 linked publication.
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 16 Feb 2015.