Energy Turnover and Appetite

Obesity Clinical Trial

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Official title:

Effect of the Degree of Energy Turnover on Appetitive Responses in Adolescents With Obesity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05365685
• Other study ID #: RBHP 2021 BOIRIE 2
• Secondary ID: 2021-A02867-34
• Status: Recruiting
• Phase: N/A
• Start date: August 27, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: March 2022
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise Laclautre
• Phone: 334.73.754.963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to compare the effect of a low versus moderate versus high energy turnover on energy intake, appetite and food reward, in adolescents with obesity. 18 adolescents with obesity will then complete three experimental sessions in a randomized order: low, high and moderate Energy turnover.

Description:

A total of 18 adolescents with obesity, aged 12-16 years olds will complete three experimental sessions in a randomized order: i) low energy turnover; ii) Moderate energy turnover and ; iii) High energy turnover. Their ad libitum energy intake at dinner will be assessed through an ad libitum buffet-type meal, their food reward assessed right before the dinner meal and their appetite sensation at regular intervals during the day.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2022
• 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

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Low energy turnover
Low Energy Turnover. The adolescents with ingest low energy intake at lunch and breakfast and will not perform physical exercise during the day. The will 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. Moderate Energy Turnover. The adolescents with ingest moderate energy intake at lunch and breakfast and will perform one 45 minutes physical exercise during the day. The will 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. High Energy Turnover. The adolescents with ingest high energy intake at lunch and breakfast and will perform two 45-minute physical exercises during the day. The will 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.

Locations

Country	Name	City	State
France	CHU clermont-ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 a nutritional software.	it will be assessed at dinner baseline
Secondary	Hunger feelings	hunger area under the curve will be assessed using visual analogue scale through a the day	immediately after breakfast/lunch/dinner on day 1
Secondary	Food reward	: The participants will be asked to complete a validated computer-based procedure to measure food reward (Leeds Food Preference Questionnaire; LFPQ). Briefly, the LFPQ provides measures of the wanting and liking for an array of food images, varying in both fat content and taste.	it will be assessed at dinner baseline