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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04739189
Other study ID # RBHP 2020 JULIAN
Secondary ID 2020-A03567-32
Status Completed
Phase N/A
First received
Last updated
Start date August 28, 2021
Est. completion date October 3, 2021

Study information

Verified date February 2022
Source University Hospital, Clermont-Ferrand
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date October 3, 2021
Est. primary completion date October 3, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years to 17 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.
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.

Locations

Country Name City State
France Chu Clermont Ferrand Clermont-Ferrand

Sponsors (3)

Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand Laboratoire AME2P, Tza Nou - Maison médicale pour enfants et adolescentes

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from different intervention of energy intake measured during an ad libitum buffet meal (in kcal) 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. day 1, day 8, day 15
Secondary Hunger feelings hunger area under the curve will be assessed using visual analogue scale through a the day day 1, day 8, day 15
Secondary Food reward The participants will be asked to complete a validated computer-based procedure to measure food reward (Leeds Food Preference Questionnaire; LFPQ) day 1, day 8, day 15
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