Energy Intake, Exercise and Energy Replacement

Pediatric Obesity Clinical Trial

Official title:

Does Energy Replacement Modify Post-exercise Energy Intake in Adolescents With Obesity?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03742622
• Other study ID #: CHU-415
• Status: Completed
• Phase: N/A
• Start date: November 17, 2018
• Est. completion date: March 3, 2019

Study information

• Verified date: September 2019
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the present study is to compare the effect of an exercise alone versus. An exercise followed by the ingestion of an energy replacement snack on the following energy intake, food reward and appetite feelings in adolescents with obesity.

Description:

The present study will compare the nutritional response to the realisation of an acute exercise with and without an energy replacement snack on the following energy intake 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 during the morning; iii) one session with the same exercise followed by a snack covering the exercise-induced energy expenditure. Their ad libitum energy intake will be assessed at the following meal 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: March 3, 2019
• Est. primary completion date: March 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Pediatric Obesity

Intervention

Behavioral:
• CON . control condition without exercise / rest condition
CON . 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.
• EX. Condition with an acute exercise set in the middle of the morning
EX. Condition with an acute exercise set in the middle of the morning The adolescents will be asked to complete a 30 minutes exercise set at 65% of their capacities (cycling) in 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
• EX+R. condition with an acute exercise set in the morning and followed by a energy replacement snack
EX+R. condition with an acute exercise set in the morning and followed by a energy replacement snack The adolescents will be asked to complete a 30 minutes exercise set at 65% of their capacities (cycling) in the morning followed by a snack that will cover the whole exercise-induced energy expenditure. They will then 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.

Locations

Country	Name	City	State
France	Chu Clermont-Ferrand	Clermont-Ferrand

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	SSR Nutrition-Obésité – 33-35 rue Maréchal Leclerc – 63000 Clermont-Ferrand, Tza Nou - Maison médicale pour enfants et adolescentes – 230, rue Vercingétorix – B.P. 77 – 63150 La Bourboule, University of Clermont-Auvergne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Energy intake measured during an ad libitum buffet meal (in kcal).	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	at lunch (at day 1)
Secondary	Measurement of hunger feelings	hunger area under the curve will be assessed using visual analogue scale through a the day (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	at day 1
Secondary	Food reward	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).Briefly, the LFPQ provides measures of the wanting and liking for an array of food images, varying in both fat content and taste	at day 1