- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03968458
Effect of Exercise Timing on Energy Intake and Appetite in Adolescents With Obesity: the TIMEX 3 Study (TIMEX 3)
October 4, 2019 updated by: University Hospital, Clermont-Ferrand
The aim of the present study is to compare the effect of the timing (30 vs. 90 minutes) between a fixed exercise and the following test meal on energy intake, appetite feelings and food reward in adolescents with obesity.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
The present study will compare the nutritional response to the realisation of an acute exercise 90 minutes or 30 minutes before an ad libitum buffet meal 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 90 minutes before lunch; iii) one session with the same exercise performed 30 minutes before 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 (Anticipated)
18
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, 63000
- Recruiting
- CHU de 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: Obese adolescents
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.
Condition with an acute exercise set 30 minutes before lunch The adolescents will be asked to complete a 30 minutes exercise set at 65% of their capacities (cycling), 30 minutes before lunch.
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.
condition with an acute exercise set 90 minutes before lunch.
The adolescents will be asked to complete a 30 minutes exercise set at 65% of their capacities (cycling), 30 minutes before lunch.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of energy intake measured during an ad libitum buffet meal (in kcal).
Time Frame: day 1 , day 8, day 15
|
Change of 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 |
---|---|---|
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)
|
day 1 , day 8, day 15
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this 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 (Anticipated)
June 30, 2020
Study Completion (Anticipated)
July 31, 2020
Study Registration Dates
First Submitted
April 29, 2019
First Submitted That Met QC Criteria
May 27, 2019
First Posted (Actual)
May 30, 2019
Study Record Updates
Last Update Posted (Actual)
October 7, 2019
Last Update Submitted That Met QC Criteria
October 4, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RBHP 2019 BOIRIE 2
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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