- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05365685
Energy Turnover and Appetite (NEXT)
Effect of the Degree of Energy Turnover on Appetitive Responses in Adolescents With Obesity
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Clermont-Ferrand, France
- Chu Clermont-Ferrand
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: adolescents with obesity
There is only one arm as this is an acute randomized study comparing three different conditions within the same sample of participants.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Energy intake measured during an ad libitum buffet meal (in kcal).
Time Frame: it will be assessed at dinner baseline
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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.
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it will be assessed at dinner baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Hunger feelings
Time Frame: immediately after breakfast/lunch/dinner on day 1
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hunger area under the curve will be assessed using visual analogue scale through a the day
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immediately after breakfast/lunch/dinner on day 1
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Food reward
Time Frame: it will be assessed at dinner baseline
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: 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.
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it will be assessed at dinner baseline
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Collaborators and Investigators
Investigators
- Principal Investigator: Yves Boirie, University Hospital, Clermont-Ferrand
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RBHP 2021 BOIRIE 2
- 2021-A02867-34 (Other Identifier: Clermont Ferrand University Hospital)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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