Effect of a Physical Activity Program on the Hormonal Regulation of Food Intake (APHRO)

April 2, 2013 updated by: University Hospital, Clermont-Ferrand

Effect of a 3 Months Physical Activity Program on the Hormonal Regulation of Food Intake by Intense Physical Activity in Overweight Adolescents

The primary purpose of this protocol is to assess the hormonal regulation of satiety by an intense exercise before and after a 3 month physical activity program. Hormones assessed are: leptin, grhélin, Cholecystokinin, Glucagon-Like-Peptid-1 (GLP-1), PYY.

It is well known that in overweight adults and children also, an intense physical exercise diminish the food intake relatively to the total energy expenditure and this effect is persistent after a 6 weeks physical activity program.

Our hypothesis are: a diminution of food intake after the intense physical exercise and a persistent diminution of food intake after the 3 month physical activity program, an augmentation of levels of GLP-1 and PYY during the intense exercise before and after the physical activity program, a diminution of the level of GLP-1 and leptin before and after the physical activity program

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

There is two sequences, one before and one after the physical activity program. Each sequence contains one "rest" session and one "exercise" session.

Each session contains : blood sample at regular interval (Leptin, Ghrélin, CCK, PYY, GLP-1), a sleeping assessment (Pittsburg scale), an assessment of hunger sensations at regular interval, an assessment of food intake in a "ad libitum" lunch and in the diner indirectly by the SU.VI.MAX. tool.

During the " rest " session :

Blood samples, assessment of hunger sensation, assessment of food intake are realized during the morning. Physical condition (VO2 max, DEXA, and muscular test), insulin-sensibility, lipid profile, are also assessed.

During the "exercise" session: it is identical to the first session but an intense exercise of 40 minutes is realized at 70% of the patient's VO2 max. The peripherical blood output is measured by a non-invasive method: the Near-Infra-Red-Spectroscopy, during the exercise.

The 3-months-physical activity program : there is 4 sessions of 30 minutes and 2 sessions of 1 hour per week. Most of exercises sessions are realized at home but one 1-hour session per week is controled with a sports educator.

Study Type

Interventional

Enrollment (Anticipated)

30

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

      • Clermont-Ferrand, France, 63003
        • CHU clermont-ferrand

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

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Overweight adolescents (over the 90 th percentile of the international cut-off point)

  • With a computer and an internet connection
  • Sedentary (according to the IPAQ-A questionnaire)
  • Without eating disorders (according to the DEBQ questionnaire)

Exclusion Criteria:

  • Medical or surgical antecedents that are incompatible with the study: cardiovascular, endocrine or digestive disease.
  • Drugs that could interfere with the results of the study
  • Surgical intervention in the 3 months
  • Regular consumption of tobacco or Alcohol
  • patients on a diet with caloric restriction
  • Refusal to sign the consent form
  • Regular practice of sport and intensive

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: obesity
There is two sequences, one before and one after the physical activity program. Each sequence contains one "rest" session and one "exercise" session

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison before and after the physical activity program of the effect of intense exercise on kinetic of secretion of regulation hormones: Leptin, Grhélin, CCK, PYY3-36, GLP-1
Time Frame: after 3 months of physical activity
after 3 months of physical activity

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparison, before and after the physical activity program, of Hunger sensation by Visual Analogic Scales
Time Frame: after 3 months of physical activity
after 3 months of physical activity
Comparison, before and after the physical activity program of food intake
Time Frame: after 3 months of physical activity
after 3 months of physical activity
Comparison, before and after the physical activity program of insulinosensibility
Time Frame: after 3 months of physical activity
after 3 months of physical activity
Comparison, before and after the physical activity program of peripheral blood output
Time Frame: after 3 months of physical activity
after 3 months of physical activity
Comparison, before and after the physical activity program of sleep quality
Time Frame: agter 3 months of physical activity
agter 3 months of physical activity
Comparison, before and after the physical activity program of physical condition
Time Frame: after 3 months of physical activity
after 3 months of physical activity

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Etienne MERLIN, University Hospital, Clermont-Ferrand

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, 2012

Primary Completion (Anticipated)

May 1, 2014

Study Completion (Anticipated)

July 1, 2014

Study Registration Dates

First Submitted

February 28, 2013

First Submitted That Met QC Criteria

April 2, 2013

First Posted (Estimate)

April 5, 2013

Study Record Updates

Last Update Posted (Estimate)

April 5, 2013

Last Update Submitted That Met QC Criteria

April 2, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • CHU-0149

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.

Clinical Trials on Obesity

Clinical Trials on Physical activity

3
Subscribe