Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Energy Intake, Exercise and Energy Replacement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03742622
Recruitment Status : Recruiting
First Posted : November 15, 2018
Last Update Posted : February 4, 2019
Sponsor:
Collaborators:
Tza Nou - Maison médicale pour enfants et adolescentes – 230, rue Vercingétorix – B.P. 77 – 63150 La Bourboule
SSR Nutrition-Obésité – 33-35 rue Maréchal Leclerc – 63000 Clermont-Ferrand
University of Clermont-Auvergne
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Brief Summary:
The aim of the present study is to compare the effect of an exercise alone versus. An exercise followed by the ingestion of an energy replacement snack on the following energy intake, food reward and appetite feelings in adolescents with obesity.

Condition or disease Intervention/treatment Phase
Pediatric Obesity Behavioral: CON . control condition without exercise / rest condition Behavioral: EX. Condition with an acute exercise set in the middle of the morning Behavioral: EX+R. condition with an acute exercise set in the morning and followed by a energy replacement snack Not Applicable

Detailed Description:
The present study will compare the nutritional response to the realisation of an acute exercise with and without an energy replacement snack on the following energy intake in adolescents with obesity. 18 adolescents with obesity will be asked to randomly complete three experimental sessions: i) one control session (rest); ii) one session with an acute exercise realized during the morning; iii) one session with the same exercise followed by a snack covering the exercise-induced energy expenditure. Their ad libitum energy intake will be assessed at the following meal as well as at dinner time. Appetite feelings will be assessed at regular intervals and their food reward in response to the lunch will also be assessed.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: no masking
Primary Purpose: Treatment
Official Title: Does Energy Replacement Modify Post-exercise Energy Intake in Adolescents With Obesity?
Actual Study Start Date : November 15, 2018
Estimated Primary Completion Date : February 15, 2019
Estimated Study Completion Date : February 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Obese adolescents
18 adolescents with obesity are involved and will perform the three conditions
Behavioral: CON . control condition without exercise / rest condition
CON . Control condition without exercise / rest condition. The adolescents will be asked to remain quiet and at rest during the morning and will receive an ad libitum meal at lunch and dinner times. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals.

Behavioral: EX. Condition with an acute exercise set in the middle of the morning
EX. Condition with an acute exercise set in the middle of the morning The adolescents will be asked to complete a 30 minutes exercise set at 65% of their capacities (cycling) in the morning and will receive an ad libitum meal at lunch and dinner times. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals

Behavioral: EX+R. condition with an acute exercise set in the morning and followed by a energy replacement snack
EX+R. condition with an acute exercise set in the morning and followed by a energy replacement snack The adolescents will be asked to complete a 30 minutes exercise set at 65% of their capacities (cycling) in the morning followed by a snack that will cover the whole exercise-induced energy expenditure. They will then receive an ad libitum meal at lunch and dinner times. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals.




Primary Outcome Measures :
  1. Energy intake measured during an ad libitum buffet meal (in kcal). [ Time Frame: at lunch (at day 1) ]
    food intake will be measured ad libitum during a lunch buffet. The adolescents will be offered an ad libitum buffet-type meal composed based on their food intake preferences. Their intake will be weighted using an electronic food scale by a member of the investigation team and then analysed using Bilnuts software


Secondary Outcome Measures :
  1. Measurement of hunger feelings [ Time Frame: at day 1 ]
    hunger area under the curve will be assessed using visual analogue scale through a the day (Leeds Food Preference Questionnaire; LFPQ) Briefly, the LFPQ provides measures of the wanting and liking for an array of food images, varying in both fat content and taste

  2. Food reward [ Time Frame: at day 1 ]
    The participants will be asked to complete a validated computer-based procedure to measure food reward (Leeds Food Preference Questionnaire; LFPQ) (Finlayson, King et al. 2008).Briefly, the LFPQ provides measures of the wanting and liking for an array of food images, varying in both fat content and taste



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI percentile > 97th percentile according to the french curves.
  • ages 12-16 years old
  • Signed consent form
  • being registered in the national social security system
  • no contraindication to physical activity

Exclusion Criteria:

  • Previous surgical interventions that is considered as non-compatible with the study.
  • Diabetes
  • weight loss during the last 6 months
  • cardiovascular disease or risks

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03742622


Contacts
Layout table for location contacts
Contact: Lise LACLAUTRE 04 73 75 49 63 drci@chu-clermontferrand.fr

Locations
Layout table for location information
France
Chu Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Lise LACLAUTRE    04 73 75 49 63    drci@chu-clermontferrand.fr   
Principal Investigator: Yves BOIRIE         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Tza Nou - Maison médicale pour enfants et adolescentes – 230, rue Vercingétorix – B.P. 77 – 63150 La Bourboule
SSR Nutrition-Obésité – 33-35 rue Maréchal Leclerc – 63000 Clermont-Ferrand
University of Clermont-Auvergne
Investigators
Layout table for investigator information
Principal Investigator: Yves BOIRIE University Hospital, Clermont-Ferrand

Layout table for additonal information
Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT03742622     History of Changes
Other Study ID Numbers: CHU-415
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: February 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Clermont-Ferrand:
appetite control
obesity
Adolescents
exercise
Energy replacement

Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms