Acute Exercise and Energy Balance Regulation: Effect of Intensity

Obesity Clinical Trial

Official title:

Regulation of the Energy Balance Following an Acute Exercise in Metabolic Chambers: Effect of the Exercise Intensity, Age and Weight Status

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01036360
• Other study ID #: CHU-0063
• Status: Recruiting
• Phase: N/A
• First received: December 18, 2009
• Last updated: January 18, 2011
• Start date: December 2009
• Est. completion date: June 2011

Study information

• Verified date: January 2011
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Obesity

Intervention

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

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Regional Program for Clinical Research 2009 (PHRC 2009), Thermal Institution of Brides les Bains (FRANCE)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		over the 24 hours	Yes
Secondary	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		with an interval of at least 7 days	Yes