- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02157233
Post-exercise Food Intake Regulation in a Hot Environment (APPA)
February 12, 2015 updated by: University of the French West Indies and French Guiana
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guadeloupe
-
Les Abymes, Guadeloupe, France
- CREPS
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- healthy and physically active men aged 18-30 years
Exclusion Criteria:
- any physical or medical problem liable to limit the subjects' ability to perform the exercise testing in safe conditions,
- ear troubles
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Hot environment
Subjects will perform the intervention in a hot environment (33°C)
|
|
Sham Comparator: Neutral environment
Subjects will perform the intervention in a neutral environment (22°C)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Relative post-exercise and post-rest energy intake
Time Frame: 11 months
|
11 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Appetite hormones
Time Frame: 13 months
|
insulin, CCK, leptin, ghrelin, pancreatic peptide
|
13 months
|
Heart rate variability
Time Frame: 11 months
|
11 months
|
|
Tympanic temperature
Time Frame: 11 months
|
11 months
|
|
Peak exercise capacity
Time Frame: 11 months
|
11 months
|
|
Appetite visual analogic scale
Time Frame: 11 months
|
11 months
|
|
metabolic markers
Time Frame: 13 months
|
glucose, lipid profile, cortisol
|
13 months
|
vascular biomarkers
Time Frame: 13 months
|
usCRP, inflammatory markers, hemorheological markers
|
13 months
|
comfort visual scale
Time Frame: 11 months
|
11 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2013
Primary Completion (Actual)
January 1, 2015
Study Completion (Actual)
February 1, 2015
Study Registration Dates
First Submitted
June 2, 2014
First Submitted That Met QC Criteria
June 4, 2014
First Posted (Estimate)
June 5, 2014
Study Record Updates
Last Update Posted (Estimate)
February 16, 2015
Last Update Submitted That Met QC Criteria
February 12, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- 13/N/01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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