- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03807609
Energy Intake and Exercise Timing
September 11, 2019 updated by: University Hospital, Clermont-Ferrand
Does Exercise Timing Modify Post-exercise Energy Intake in Adolescents With Obesity
The aim of the present study is to compare the effect of an exercise performed 180 or 30 minutes before lunch on the energy intake of adolescents with obesity.
Study Overview
Status
Completed
Conditions
Detailed Description
The present study will compare the nutritional response to the realisation of an acute exercise 180 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 180 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 (Actual)
15
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: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: CON .
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.
|
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.
|
|
Experimental: EX -30.
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.
|
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.
|
|
Experimental: EX-180
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 appetite feelings will be assessed at regular intervals.
|
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 |
|---|---|---|
|
Energy intake measured during an ad libitum buffet meal (in kcal).
Time Frame: at day 1
|
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 (Casio Scale, units: grams) by a member of the investigation team and then analysed using Bilnuts software.
|
at day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hunger feelings
Time Frame: at day 1
|
hunger area under the curve will be assessed using visual analogue scale (VAS) through a the day ranging from 0 to 150, 0 being "not at all", 150 being "completely".
The question asked being: How hungry are you right now?"
|
at day 1
|
|
Food reward
Time Frame: at day 1
|
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.To measure the explicit liking and explicit wanting, participants are asked to rate the extent to which they "liked" or "wanted" each randomly presented food item with a 100-mm visual analogue scale. .
The construct from the scales are : Explicit liking; Explicit Wanting; Implicit liking, implicit wanting, Fat Choice and Fat Taste.
Each component ranged from -50 to +50.
There is no total score.
|
at day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
January 19, 2019
Primary Completion (Actual)
March 31, 2019
Study Completion (Actual)
March 31, 2019
Study Registration Dates
First Submitted
January 15, 2019
First Submitted That Met QC Criteria
January 16, 2019
First Posted (Actual)
January 17, 2019
Study Record Updates
Last Update Posted (Actual)
September 13, 2019
Last Update Submitted That Met QC Criteria
September 11, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHU-419
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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