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Appetite Response to Exercise- Versus Energy Restriction-induced Energy Deficit in Adolescents With Obesity. (IDEX1)

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ClinicalTrials.gov Identifier: NCT04739189
Recruitment Status : Completed
First Posted : February 4, 2021
Last Update Posted : February 10, 2022
Sponsor:
Collaborators:
Tza Nou - Maison médicale pour enfants et adolescentes
Laboratoire AME2P
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Study Description
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Brief Summary:
The aim of the present study is to compare the effect of iso-energetic energy deficits induced by exercise or dietary restriction on energy intake and appetite feelings in adolescents with obesity

Condition or disease Intervention/treatment Phase
Pediatric Obesity Behavioral: Con : control condition without exercise / rest condition Behavioral: Def-EX : Condition with an exercise-induced energy deficit Behavioral: Def-EI : Condition with an energy-restriction energy deficit Not Applicable

Detailed Description:

The present study will compare the nutritional response to an energy deficit of 400 kcal induced once by realisation of an acute exercise set at moderate intensity and once by a dietary restriction imposed at lunch (compared with a control condition). 18 adolescents with obesity will be asked to randomly complete three experimental sessions: i) one control session (CON); ii) one session with an exercise-induced energy deficit (Def-EX); iii) one session with an energy restriction-induced energy deficit (Def-EI).

Their ad libitum energy intake will be assessed during dinner time. Appetite feelings will be assessed at regular intervals and their food reward in response to the lunch will also be assessed.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Appetite Response to Exercise- Versus Energy Restriction-induced Energy Deficit in Adolescents With Obesity.
Actual Study Start Date : August 28, 2021
Actual Primary Completion Date : October 3, 2021
Actual Study Completion Date : October 3, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: Obese adolescent Behavioral: Con : control condition without exercise / rest condition
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 dinner time. Their food reward will be assessed before dinner. Their appetite feelings will be assessed at regular intervals.

Behavioral: Def-EX : Condition with an exercise-induced energy deficit
Condition with an exercise-induced energy deficit The adolescents will be asked to complete an acute exercise set at 65% of their capacities (cycling) during the afternoon, inducing an energy expenditure of 400 kcal. Dinner will be served ad libitum. Their food reward will be assessed before dinner. Their appetite feelings will be assessed at regular intervals.

Behavioral: Def-EI : Condition with an energy-restriction energy deficit
Condition with an energy-restriction energy deficit The adolescents will be asked to remain quiet during the whole day (no physical activity). They will receive a calibrated breakfast reduced from 400 kcal compare to their CON and Def-EX conditions. Dinner will be served ad libitum. Their food reward will be assessed before dinner. Their appetite feelings will be assessed at regular intervals.


Outcome Measures
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Primary Outcome Measures :
  1. Change from different intervention of energy intake measured during an ad libitum buffet meal (in kcal) [ Time Frame: day 1, day 8, day 15 ]
    food intake will be measured ad libitum during a dinner 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. Hunger feelings [ Time Frame: day 1, day 8, day 15 ]
    hunger area under the curve will be assessed using visual analogue scale through a the day

  2. Food reward [ Time Frame: day 1, day 8, day 15 ]
    The participants will be asked to complete a validated computer-based procedure to measure food reward (Leeds Food Preference Questionnaire; LFPQ)


Eligibility Criteria
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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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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): NCT04739189


Locations
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France
Chu Clermont Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Tza Nou - Maison médicale pour enfants et adolescentes
Laboratoire AME2P
Investigators
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Principal Investigator: Valérie JULIAN University Hospital, Clermont-Ferrand
More Information
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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT04739189    
Other Study ID Numbers: RBHP 2020 JULIAN
2020-A03567-32 ( Other Identifier: 2020-A03567-32 )
First Posted: February 4, 2021    Key Record Dates
Last Update Posted: February 10, 2022
Last Verified: February 2022

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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 Deficit
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overweight
Overnutrition
Nutrition Disorders
 Body Weight
Butyl phosphorotrithioate
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action