- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04739189
Appetite Response to Exercise- Versus Energy Restriction-induced Energy Deficit in Adolescents With Obesity. (IDEX1)
Study Overview
Status
Conditions
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Clermont-Ferrand, France, 63003
- CHU Clermont Ferrand
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Obese adolescent
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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.
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.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from different intervention of energy intake measured during an ad libitum buffet meal (in kcal)
Time Frame: day 1, day 8, day 15
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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 Bilnuts software.
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day 1, day 8, day 15
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hunger feelings
Time Frame: day 1, day 8, day 15
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hunger area under the curve will be assessed using visual analogue scale through a the day
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day 1, day 8, day 15
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Food reward
Time Frame: day 1, day 8, day 15
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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)
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day 1, day 8, day 15
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Collaborators and Investigators
Investigators
- Principal Investigator: Valérie JULIAN, 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 2020 JULIAN
- 2020-A03567-32 (Other Identifier: 2020-A03567-32)
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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