search
Back to results

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

Primary Purpose

Obesity

Status
Suspended
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Physical activity
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Appetite regulation, Hormones, Adolescents, Exercise

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Clermont-Ferrand

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

obesity

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Comparison, before and after the physical activity program, of Hunger sensation by Visual Analogic Scales
Comparison, before and after the physical activity program of food intake
Comparison, before and after the physical activity program of insulinosensibility
Comparison, before and after the physical activity program of peripheral blood output
Comparison, before and after the physical activity program of sleep quality
Comparison, before and after the physical activity program of physical condition

Full Information

First Posted
February 28, 2013
Last Updated
April 2, 2013
Sponsor
University Hospital, Clermont-Ferrand
search

1. Study Identification

Unique Protocol Identification Number
NCT01824680
Brief Title
Effect of a Physical Activity Program on the Hormonal Regulation of Food Intake
Acronym
APHRO
Official Title
Effect of a 3 Months Physical Activity Program on the Hormonal Regulation of Food Intake by Intense Physical Activity in Overweight Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Suspended
Study Start Date
October 2012 (undefined)
Primary Completion Date
May 2014 (Anticipated)
Study Completion Date
July 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Appetite regulation, Hormones, Adolescents, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
obesity
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Physical activity
Intervention Description
There is two sequences, one before and one after the physical activity program. Each sequence contains one "rest" session and one "exercise" session
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Comparison, before and after the physical activity program, of Hunger sensation by Visual Analogic Scales
Time Frame
after 3 months of physical activity
Title
Comparison, before and after the physical activity program of food intake
Time Frame
after 3 months of physical activity
Title
Comparison, before and after the physical activity program of insulinosensibility
Time Frame
after 3 months of physical activity
Title
Comparison, before and after the physical activity program of peripheral blood output
Time Frame
after 3 months of physical activity
Title
Comparison, before and after the physical activity program of sleep quality
Time Frame
agter 3 months of physical activity
Title
Comparison, before and after the physical activity program of physical condition
Time Frame
after 3 months of physical activity

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Etienne MERLIN
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs