Appetite Response to Exercise- Versus Mixed (Exercise + Dietary Restriction)-Induced Energy Deficit in Adolescents With Obesity

Pediatric Obesity Clinical Trial

— IDEX2  

Official title:

Appetite Response to Exercise- Versus Mixed (Exercise + Dietary Restriction)-Induced Energy Deficit in Adolescents With Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04734639
• Other study ID #: RBHP 2020 JULIAN 2
• Secondary ID: 2020-A03568-31
• Status: Completed
• Phase: N/A
• Start date: April 24, 2021
• Est. completion date: June 30, 2021

Study information

• Verified date: September 2021
• 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 iso-energetic energy deficits induced by energy restriction alone or exercise + dietary restriction (Mixed deficit) on energy intake and appetite feelings in adolescents with obesity.

Description:

The present study will compare the nutritional response to an energy deficit of 500 kcal induced once by dietary restriction alone and once by a mixed deficit (50% by exercise and 50% by dietary restriction) (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 a dietary-induced energy deficit (Def-EI); iii) one session with a mixed deficit (50% by exercise and 50% by dietary restriction) (Def-Mixed).

Their ad libitum energy intake will be assessed 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: 17
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 17 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
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.
• Def-Mixed. Condition with a mixed energy deficit induced by exercise + dietary restriction.
Def-Mixed. Condition with an exercise-induced energy deficit The adolescents will received a calibrated lundh meal with a deduction of 250 kcal compared with the lunch meal of Con; and will be asked to realise an acute exercise set at 65% of their capacities (cycling) during the afternoon, inducing an energy expenditure of 250 kcal. Dinner will be served ad libitum. Their food reward will be assessed before dinner. Their appetite feelings will be assessed at regular intervals.
• Def-EI. Condition with an energy-restriction energy deficit
Condition with an energy-restriction energy deficit The adolescents will receive a calibrated breakfast reduced from 500 kcal compare to their CON and Def-mixed conditions. Dinner will be served ad libitum. Their food reward will be assessed before dinner. Their appetite feelings will be assessed at regular intervals.

Locations

Country	Name	City	State
France	Chu Clermont Ferrand	Clermont-Ferrand

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Laboratoire AME2P, Tza Nou - Maison médicale pour enfants et adolescentes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from different intervention of energy intake measured during an ad libitum buffet meal (in kcal).	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.	day 1, day 8, day 15
Secondary	Hunger feelings	hunger area under the curve will be assessed using visual analogue scale through a the day	day 1, day 8, day 15
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).	day 1, day 8, day 15