Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Acute Exercise and Energy Balance Regulation: Effect of Intensity

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by University Hospital, Clermont-Ferrand.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Regional Program for Clinical Research 2009 (PHRC 2009)
Thermal Institution of Brides les Bains (FRANCE)
Information provided by:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01036360
First received: December 18, 2009
Last updated: January 18, 2011
Last verified: January 2011

December 18, 2009
January 18, 2011
December 2009
June 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01036360 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Acute Exercise and Energy Balance Regulation: Effect of Intensity
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.

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.

Observational
Time Perspective: Prospective
Not Provided

Defined population

Non-Probability Sample

20 adolescent boys (10 obese and 10 leans) and 20 men (10 obese and 10 lean

Obesity
Other: metabolic chamber
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
physical activity
Intervention: Other: metabolic chamber

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
June 2011
June 2011   (final data collection date for primary outcome measure)

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
Male
18 Years to 30 Years
Yes
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr
France
 
NCT01036360
CHU-0063
Not Provided
Patrick LACARIN, CHU Clermont-Ferrand
University Hospital, Clermont-Ferrand
  • Regional Program for Clinical Research 2009 (PHRC 2009)
  • Thermal Institution of Brides les Bains (FRANCE)
Principal Investigator: Corinne BOUTELOUP CHU Clermont-Ferrand (CRNH)
University Hospital, Clermont-Ferrand
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP