- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03967782
Effect of the Exercise-meal Timing on Energy Intake and Appetite in Adolescents With Obesity (TIMEX2)
June 9, 2020 updated by: University Hospital, Clermont-Ferrand
Effect of the Exercise-meal Timing on Energy Intake and Appetite in Adolescents With Obesity: the TIMEX 2 Study
The aim of the present study is to compare the effect of realizing an exercise right before or right after a meal of on energy intake, appetite feelings and food reward in adolescents with obesity.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The present study will compare the nutritional response to the realisation of an acute exercise right before or right after lunch 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 right before lunch; iii) one session with an acute exercise realized right after 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.
Study Type
Interventional
Enrollment (Actual)
17
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Clermont-Ferrand, France, 63003
- CHU Clermont Ferrand
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 16 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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: cohorte 1
18 adolescents with obesity are involved and will perform the three conditions.
|
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.
Other Names:
Condition with an acute exercise set right before lunch The adolescents will be asked to complete a 30 minutes exercise set at 65% of their capacities (cycling) right before ad ad libitum lunch meal.
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.
Other Names:
. condition with an acute exercise set right after lunch.
The adolescents will be asked to complete a 30 minutes exercise set at 65% of their capacities (cycling) right after an ad libitul buffet meal.
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in energy intake measured during an ad libitum buffet meal (in kcal)
Time Frame: day 1 , day 8, day 15
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hunger feelings
Time Frame: day 1 , day 8, day 15
|
hunger area under the curve will be assessed using visual analogue scale through a the day
|
day 1 , day 8, day 15
|
|
Food reward
Time Frame: day 1 , day 8, day 15
|
The participants will be asked to complete a validated computer-based procedure to measure food reward (Leeds Food Preference Questionnaire; LFPQ) (Finlayson, King et al. 2008).
|
day 1 , day 8, day 15
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 31, 2019
Primary Completion (Actual)
September 29, 2019
Study Completion (Actual)
October 30, 2019
Study Registration Dates
First Submitted
May 27, 2019
First Submitted That Met QC Criteria
May 27, 2019
First Posted (Actual)
May 30, 2019
Study Record Updates
Last Update Posted (Actual)
June 11, 2020
Last Update Submitted That Met QC Criteria
June 9, 2020
Last Verified
October 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RBHP 2019 BOIRIE
- 2019-A00507-50 (Other Identifier: 2019-A00507-50)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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