Clinical trial NCT03466359: Energy Intake and Energy Deficit in Obese Adolescents
Official title: Nutritional Responses to Chronic Exercise- Versus Energy Restriction-induced Energy Deficits in Obese Adolescents
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pediatric Obesity
Keywords: appetite control
obesity
Adolescents
Physical activity
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Tza Nou - Maison médicale pour enfants et adolescentes - 230, rue Vercingétorix - B.P. 77 - 63150 La Bourboule
name: SSR Nutrition-Obésité - 33-35 rue Maréchal Leclerc - 63000 Clermont-Ferrand
name: Laboratoire AME2P. Campus universitaire des cezeaux, 63170 Aubiere, Cedex
First posted: 2018-03-15
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present study is to compare the effect of two weight loss interventions inducing the same energy deficit but one based on exercise and one using dietary restriction, on appetite control in obese adolescents. Investigator hypothesis that daily energy intake and hunger will be increased in the dietary restriction group but not in response to the exercise program.

Detailed description: The present study will compare the nutritional responses to two 4-month weight loss programs inducing the same energy deficit in obese adolescents, one based on exercise and the other one using dietary restriction. After a first 4-month phase stabilizing the adolescents' daily energy intake and expenditure, half of the sample with increase their physical activity to induce a 10% increase of their daily energy expenditure (maintaining the same energy intake) while the other half will stick with the same physical activity program but reduce their daily intake to match for the same 10% energy deficit. Before, at the end and 4 months after the intervention, Investigator will assess the adolescents' energy intake and appetite control by measuring: ad libitum energy intake, appetite feelings throughout the day, food preferences, food reward. But also all the potential underneath mechanisms based on gastro-peptides and adipokines. Finally, sleep metabolism will be assessed using polysomnography as a potential link between weight loss and appetite control. Body composition, quality of life, aerobic capacities and resting metabolic rate will also be measured at each time point.

Eligibility 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

Primary outcomes:
measure: Changes in energy intake at lunch time
timeFrame: Before, after 10 months and 4 month after the intervention
Secondary outcomes:
measure: change in FM
timeFrame: Before, after 10 months and 4 month after the intervention
measure: Aerobic capacity
timeFrame: Before, after 10 months and 4 month after the intervention
measure: Insulin concentration
timeFrame: Before, after 10 months and 4 month after the intervention
measure: Glycaemia concentration
timeFrame: Before, after 10 months and 4 month after the intervention
measure: total cholesterol concentration
timeFrame: Before, after 10 months and 4 month after the intervention.
measure: HDL-C concentration
timeFrame: Before, after 10 months and 4 month after the intervention
measure: LDL-C concentration
timeFrame: Before, after 10 months and 4 month after the intervention
measure: Triglycerides concentration
timeFrame: Before, after 10 months and 4 month after the intervention
measure: Acylated Ghrelin concentration
timeFrame: Before, after 10 months and 4 month after the intervention
measure: Leptin concentration
timeFrame: Before, after 10 months and 4 month after the intervention
measure: Sleep metabolism
timeFrame: Before, after 10 months and 4 month after the intervention
measure: appetite feelings
timeFrame: Before, after 10 months and 4 month after the intervention
measure: Quality of life Score
timeFrame: Before, after 10 months and 4 month after the intervention
measure: Health Perception
timeFrame: Before, after 10 months and 4 month after the intervention
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Yves BOIRIE
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roche J, Corgosinho FC, Damaso AR, Isacco L, Miguet M, Fillon A, Guyon A, Moreira GA, Pradella-Hallinan M, Tufik S, Tulio de Mello M, Gillet V, Pereira B, Duclos M, Boirie Y, Masurier J, Franco P, Thivel D, Mougin F. Sleep-disordered breathing in adolescents with obesity: When does it start to affect cardiometabolic health? Nutr Metab Cardiovasc Dis. 2020 Apr 12;30(4):683-693. doi: 10.1016/j.numecd.2019.12.003. Epub 2019 Dec 16.