Energy Turnover and Appetite (NEXT)
Primary Purpose
Obesity
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Low energy turnover
Sponsored by
About this trial
This is an interventional basic science trial for Obesity
Eligibility 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
Sites / Locations
- CHU clermont-ferrandRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
adolescents with obesity
Arm Description
There is only one arm as this is an acute randomized study comparing three different conditions within the same sample of participants.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Hunger feelings
hunger area under the curve will be assessed using visual analogue scale through a the day
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.
Full Information
NCT ID
NCT05365685
First Posted
March 29, 2022
Last Updated
October 4, 2022
Sponsor
University Hospital, Clermont-Ferrand
1. Study Identification
Unique Protocol Identification Number
NCT05365685
Brief Title
Energy Turnover and Appetite
Acronym
NEXT
Official Title
Effect of the Degree of Energy Turnover on Appetitive Responses in Adolescents With Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 27, 2022 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
adolescents with obesity
Arm Type
Experimental
Arm Description
There is only one arm as this is an acute randomized study comparing three different conditions within the same sample of participants.
Intervention Type
Behavioral
Intervention Name(s)
Low energy turnover
Other Intervention Name(s)
Moderate energy turnover, High energy turnover
Intervention Description
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.
Primary Outcome Measure Information:
Title
Energy intake measured during an ad libitum buffet meal (in kcal).
Description
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.
Time Frame
it will be assessed at dinner baseline
Secondary Outcome Measure Information:
Title
Hunger feelings
Description
hunger area under the curve will be assessed using visual analogue scale through a the day
Time Frame
immediately after breakfast/lunch/dinner on day 1
Title
Food reward
Description
: 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.
Time Frame
it will be assessed at dinner baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lise Laclautre
Phone
334.73.754.963
Email
promo_interne_drci@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yves BOIRIE
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU clermont-ferrand
City
Clermont-Ferrand
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
First Name & Middle Initial & Last Name & Degree
Yves Boirie
12. IPD Sharing Statement
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Energy Turnover and Appetite
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