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Clinical Trials/NCT03466359
NCT03466359UnknownNot Applicable

Nutritional Responses to Chronic Exercise- Versus Energy Restriction-induced Energy Deficits in Obese Adolescents

University Hospital, Clermont-Ferrand2 sites in 1 country50 target enrollmentStarted: January 8, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
50
Locations
2
Primary Endpoint
Changes in energy intake at lunch time

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Care Provider)

Eligibility Criteria

Ages
12 Years to 16 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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.
  • weight loss during the last 6 months
  • cardiovascular disease or risks

Arms & Interventions

DEF-EI

Experimental

these adolescents will follow a dietary restriction of 10% of their daily energy intake.

Intervention: DEF-EI : Energy restriction induced energy deficit (Behavioral)

DEF-EX

Experimental

these adolescents will increase their physical activity-induced energy expenditure by 10% per day.

Intervention: DEF-EX : Exercise induced energy deficit (Behavioral)

Outcomes

Primary Outcomes

Changes in energy intake at lunch time

Time Frame: Before, after 10 months and 4 month after the intervention

food intake will be measured ad libitum during a lunch time buffet. The adolescents will be offered an ad libitum buffet-type meal composed based on their food intake preferences. Their intake will be assessed by a member of the investigation team

Secondary Outcomes

  • change in FM(Before, after 10 months and 4 month after the intervention)
  • Leptin concentration(Before, after 10 months and 4 month after the intervention)
  • appetite feelings(Before, after 10 months and 4 month after the intervention)
  • Quality of life Score(Before, after 10 months and 4 month after the intervention)
  • Health Perception(Before, after 10 months and 4 month after the intervention)
  • Glycaemia concentration(Before, after 10 months and 4 month after the intervention)
  • total cholesterol concentration(Before, after 10 months and 4 month after the intervention.)
  • LDL-C concentration(Before, after 10 months and 4 month after the intervention)
  • Sleep metabolism(Before, after 10 months and 4 month after the intervention)
  • Insulin concentration(Before, after 10 months and 4 month after the intervention)
  • Acylated Ghrelin concentration(Before, after 10 months and 4 month after the intervention)
  • Aerobic capacity(Before, after 10 months and 4 month after the intervention)
  • HDL-C concentration(Before, after 10 months and 4 month after the intervention)
  • Triglycerides concentration(Before, after 10 months and 4 month after the intervention)

Investigators

Sponsor
University Hospital, Clermont-Ferrand
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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