- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01036360
Acute Exercise and Energy Balance Regulation: Effect of Intensity
January 18, 2011 updated by: University Hospital, Clermont-Ferrand
Regulation of the Energy Balance Following an Acute Exercise in Metabolic Chambers: Effect of the Exercise Intensity, Age and Weight Status
Physical activity is mainly considered and use for its impact on energy expenditure in the treatment of obesity, and less is known concerning its indirect effects on energy intake.
The aim of this work is to clarify the impact of an acute bout of exercise, depending on its intensity (high versus low), on the following energy intake and nutrient utilization, in obese and non-obese boys and men.
Study Overview
Detailed Description
20 adolescent boys (10 obese and 10 leans) and 20 men (10 obese and 10 lean) will complete a sub-maximal test on a ergo cycle to draw their linear relationship between VO2 and Fc.
Then they will enter a metabolic chamber three times, for 24 hours each.
A first session will be considered as sedentary, and volunteers will remain inactive.
During the second and third session, they will have to complete a cycling test generating an energy expenditure of 400 Kcal, once at low intensity (40%VO2max) and once at high intensity (70% VO2max).
Those three sessions will be realized in a randomized order with an interval of at least 7 days and urinary collection over the 24hours will be done during all the sessions.
At the beginning of the protocol, blood samples will be taken, body composition assessed by DXA and adiposity location evaluated by MNR.
Study Type
Observational
Enrollment (Anticipated)
40
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
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Clermont-Ferrand, France, 63000
- Recruiting
- CHU Clermont-Ferrand
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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
Sampling Method
Non-Probability Sample
Study Population
20 adolescent boys (10 obese and 10 leans) and 20 men (10 obese and 10 lean
Description
Inclusion Criteria:
- Male
- Adults between 18 to 30 years old and adolescents between 12 and 15 years old
Body mass index :
- lean adults : 20 <BMI< 25 kg.m²
- obese adults : 30<BMI<38 kg.m²
- lean adolescents: BMI <90th percentile
- obese adolescents: BMI>97th percentile
- Affiliated to National Health Insurance
- Subject giving his written informed consent
- Subject considered as normal after clinical examination and medical questionnaire.
Exclusion Criteria:
- Chronic pathologies : cardiovascular diseases, cancer, chronic inflammation diseases, renal, intestinal impairments
- Refusal to be registered on the National Volunteers Data file
- Being in exclusion on the National Volunteers Data file
- Practising intensive physical exercise
- Heavy consumer of alcohol or/and tobacco
- Previous medical and/or surgery judged by the investigator as incompatible with this study
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
physical activity
|
20 adolescent boys (10 obese and 10 leans) and 20 men (10 obese and 10 lean) will complete a sub-maximal test on a ergo cycle to draw their linear relationship between VO2 and Fc.
Then they will enter a metabolic chamber three times, for 24 hours each
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The amount of energy intake over the 24 hours is the primary outcome. It will be assessed during the 3 experimental conditions: sedentary, low intensive exercise, high intensive exercise
Time Frame: over the 24 hours
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over the 24 hours
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Appetite feeling and substrate utilization are the two second outcomes. It will be assessed during the 3 experimental conditions: sedentary, low intensive exercise, high intensive exercise
Time Frame: with an interval of at least 7 days
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with an interval of at least 7 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Corinne BOUTELOUP, CHU Clermont-Ferrand (CRNH)
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.
General Publications
- Aucouturier J, Thivel D, Isacco L, Fellmann N, Chardigny JM, Duclos M, Duche P. Combined food intake and exercise unmask different hormonal responses in lean and obese children. Appl Physiol Nutr Metab. 2013 Jun;38(6):638-43. doi: 10.1139/apnm-2012-0246. Epub 2013 Jan 10.
- Thivel D, Isacco L, Montaurier C, Boirie Y, Duche P, Morio B. The 24-h energy intake of obese adolescents is spontaneously reduced after intensive exercise: a randomized controlled trial in calorimetric chambers. PLoS One. 2012;7(1):e29840. doi: 10.1371/journal.pone.0029840. Epub 2012 Jan 17.
- Thivel D, Isacco L, Taillardat M, Rousset S, Boirie Y, Morio B, Duche P. Gender effect on exercise-induced energy intake modification among obese adolescents. Appetite. 2011 Jun;56(3):658-61. doi: 10.1016/j.appet.2011.02.020. Epub 2011 Mar 2.
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
December 1, 2009
Primary Completion (Anticipated)
June 1, 2011
Study Completion (Anticipated)
June 1, 2011
Study Registration Dates
First Submitted
December 18, 2009
First Submitted That Met QC Criteria
December 18, 2009
First Posted (Estimate)
December 21, 2009
Study Record Updates
Last Update Posted (Estimate)
January 19, 2011
Last Update Submitted That Met QC Criteria
January 18, 2011
Last Verified
January 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHU-0063
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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