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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03968458
Other study ID # RBHP 2019 BOIRIE 2
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 31, 2019
Est. completion date July 31, 2020

Study information

Verified date October 2019
Source University Hospital, Clermont-Ferrand
Contact Lise Laclautre
Phone 334.73.754.963
Email promo_interne_drci@chu-clermontferrand.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the present study is to compare the effect of the timing (30 vs. 90 minutes) between a fixed exercise and the following test meal on energy intake, appetite feelings and food reward in adolescents with obesity.


Description:

The present study will compare the nutritional response to the realisation of an acute exercise 90 minutes or 30 minutes before an ad libitum buffet meal in adolescents with obesity. 18 adolescents with obesity will be asked to randomly complete three experimental sessions: i) one control session (rest); ii) one session with an acute exercise realized 90 minutes before lunch; iii) one session with the same exercise performed 30 minutes before lunch. Their ad libitum energy intake will be assessed during lunch as well as at 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 Recruiting
Enrollment 18
Est. completion date July 31, 2020
Est. primary completion date June 30, 2020
Accepts healthy volunteers No
Gender All
Age group 12 Years to 16 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. The adolescents will be asked to remain quiet and at rest during the morning and will receive an ad libitum meal at lunch and dinner times. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals.
EX-30
Condition with an acute exercise set 30 minutes before lunch The adolescents will be asked to complete a 30 minutes exercise set at 65% of their capacities (cycling), 30 minutes before lunch. Lunch will be served ad libitum as well as diner. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals.
EX-90
condition with an acute exercise set 90 minutes before lunch. The adolescents will be asked to complete a 30 minutes exercise set at 65% of their capacities (cycling), 30 minutes before lunch. Lunch will be served ad libitum as well as diner. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals.

Locations

Country Name City State
France CHU de Clermont-Ferrand Clermont-Ferrand

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change of energy intake measured during an ad libitum buffet meal (in kcal). Change of food intake will be measured ad libitum during a lunch 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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