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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02100878
Other study ID # AU1107
Secondary ID
Status Withdrawn
Phase N/A
First received March 27, 2014
Last updated April 1, 2014
Start date March 2014
Est. completion date March 2015

Study information

Verified date April 2014
Source Université Blaise Pascal, Clermont-Ferrand
Contact n/a
Is FDA regulated No
Health authority French: National Agency for medication and health products Security (ANSM)
Study type Observational

Clinical Trial Summary

Physical exercise has been shown to significantly reduce subsequent energy intake in obese adolescents but not in lean, without altering their appetite feelings. Although previous studies have pointed out the role of gastric peptides in this post exercise nutritional response, some recent work question the role of the neural system in the post exercise drive to eat. This study tends to explore whether or not an acute bout of exercise can affect the neural response to food cues in adolescents, obese or lean.


Description:

After a medical inclusion, the adolescents will have to realise a DXA to assess their body composition and a submaximal exercise to evaluate their aerobic capacities.

They will have then to enter the laboratory on 2 different occasions in a randomized order from 8am to 330pm: At 8am they will receive a calibrated breakfast. then, at 1045; they will have to complete one of the experimental condition: 1) a cycling exercise or 2) remaining sitting fpr one hour. after the one hour sitting station or the exercise bout, they will be asked to complete a computer task while and electroencephalogram will be recorded. This computer task consists in visual recognition of rare pictures compared to frequent ones (oddball method). at 1215 they will be offered ad libitum meals. At regular intervals through the day, their appetite feelings will be assessed using Visual analogue scales.

Ad libitum energy consumption will be assessed by investigators and recorded for each participants.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date March 2015
Est. primary completion date March 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 12 Years to 15 Years
Eligibility Inclusion Criteria:

- male

- 12-15 years old

- BMI defining obesity (Cole et al., 2000)

- Not being under diet restriction

- Information and consent forms have to be signed by the adolescent and his legal representative

- being registered to the national social security system

Exclusion Criteria:

- Being under medication

- contraindication to exercise

- smokers

- dieting

Study Design

Observational Model: Case-Crossover, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
France Laboratory AME2P Aubiere

Sponsors (1)

Lead Sponsor Collaborator
Université Blaise Pascal, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Neural response to food cues The electroencephalogram signals amplitude in response to visual food cues will be the primary outcome, after the exercise (during the exercise condition) and after the sitting position (during the control session) up to 2 months