History of Changes for Study: NCT04739189

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

Latest version (submitted February 9, 2022) on ClinicalTrials.gov

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Study Record Versions

Version	Submitted Date	Changes
1	February 1, 2021	None (earliest Version on record)
2	February 4, 2021	Study Status
3	March 10, 2021	Oversight and Study Status
4	April 15, 2021	Study Status
5	February 9, 2022	Recruitment Status, Study Status, Contacts/Locations and Study Design

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Study NCT04739189
Submitted Date: February 1, 2021 (v1)

Study Identification


Unique Protocol ID:	RBHP 2020 JULIAN
Brief Title:	Appetite Response to Exercise- Versus Energy Restriction-induced Energy Deficit in Adolescents With Obesity. (IDEX1)
Official Title:	Appetite Response to Exercise- Versus Energy Restriction-induced Energy Deficit in Adolescents With Obesity.
Secondary IDs:	2020-A03567-32 [2020-A03567-32]

Study Status


Record Verification:	January 2021
Overall Status:	Not yet recruiting
Study Start:	March 1, 2021
Primary Completion:	July 1, 2021 [Anticipated]
Study Completion:	July 1, 2022 [Anticipated]

First Submitted:	January 27, 2021
First Submitted that Met QC Criteria:	February 1, 2021
First Posted:	February 4, 2021 [Actual]

Last Update Submitted that Met QC Criteria:	February 1, 2021
Last Update Posted:	February 4, 2021 [Actual]

Sponsor/Collaborators


Sponsor:	University Hospital, Clermont-Ferrand
Responsible Party:	Sponsor
Collaborators:	Tza Nou - Maison médicale pour enfants et adolescentes Laboratoire AME2P

Study Description

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

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


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Not Applicable
Interventional Study Model:	Single Group Assignment
Number of Arms:	1
Masking:	None (Open Label)
Allocation:	N/A
Enrollment:	20 [Anticipated]

Arms and Interventions

Arms

Assigned Interventions

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


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


Minimum Age:	12 Years
Maximum Age:	17 Years
Sex:	All
Gender Based:
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/Locations


Central Contact Person:	Lise Laclautre Telephone: 334.73.754.963 Email: promo_interne_drci@chu-clermontferrand.fr
Study Officials:	Valérie JULIAN Principal Investigator University Hospital, Clermont-Ferrand
Locations:	France
	Chu Clermont Ferrand Clermont-Ferrand, France, 63003

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