- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04739189
Appetite Response to Exercise- Versus Energy Restriction-induced Energy Deficit in Adolescents With Obesity. (IDEX1)
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
The present study will compare the nutritional response to an energy deficit of 400 kcal induced once by realisation of an acute exercise set at moderate intensity and once by a dietary restriction imposed at lunch (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 an exercise-induced energy deficit (Def-EX); iii) one session with an energy restriction-induced energy deficit (Def-EI).
Their ad libitum energy intake will be assessed during dinner time. Appetite feelings will be assessed at regular intervals and their food reward in response to the lunch will also be assessed.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Clermont-Ferrand, Frankrike, 63003
- Chu Clermont Ferrand
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Fet tonåring
|
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.
Condition with an exercise-induced energy deficit The adolescents will be asked to complete an acute exercise set at 65% of their capacities (cycling) during the afternoon, inducing an energy expenditure of 400 kcal.
Dinner will be served ad libitum.
Their food reward will be assessed before dinner.
Their appetite feelings will be assessed at regular intervals.
Condition with an energy-restriction energy deficit The adolescents will be asked to remain quiet during the whole day (no physical activity).
They will receive a calibrated breakfast reduced from 400 kcal compare to their CON and Def-EX conditions.
Dinner will be served ad libitum.
Their food reward will be assessed before dinner.
Their appetite feelings will be assessed at regular intervals.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change from different intervention of energy intake measured during an ad libitum buffet meal (in kcal)
Tidsram: day 1, day 8, day 15
|
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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Hunger känslor
Tidsram: dag 1, dag 8, dag 15
|
hungerområdet under kurvan kommer att bedömas med hjälp av visuell analog skala genom en dag
|
dag 1, dag 8, dag 15
|
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Food reward
Tidsram: 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
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Valérie JULIAN, University Hospital, Clermont-Ferrand
Publikationer och användbara länkar
Allmänna publikationer
- Moore H, Pereira B, Fillon A, Miguet M, Masurier J, Beaulieu K, Finlayson G, Thivel D. The association between obesity severity and food reward in adolescents with obesity: a one-stage individual participant data meta-analysis. Eur J Nutr. 2024 Jun;63(4):1241-1255. doi: 10.1007/s00394-024-03348-4. Epub 2024 Feb 20.
- Fillon A, Pelissier L, Beaulieu K, Charlot K, Siroux J, Bagot S, Bailly M, Boscaro A, Finlayson G, Boirie Y, Duclos M, Isacco L, Pereira B, Julian V, Thivel D. Dietary- but not exercise-induced acute iso-energetic deficit result in short-term appetitive compensatory responses in adolescents with obesity. Appetite. 2023 Feb 1;181:106401. doi: 10.1016/j.appet.2022.106401. Epub 2022 Dec 5.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Näringsstörningar
- Övernäring
- Kroppsvikt
- Övervikt
- Patologiska tillstånd, tecken och symtom
- Beteende
- Närings- och metabola sjukdomar
- Tecken och symtom
- Fetma
- Pediatrisk fetma
- Motorisk aktivitet
- Motorisk aktivitet
- Rörelse
- Muskuloskeletala fysiologiska fenomen
- Muskuloskeletala och neurala fysiologiska fenomen
- Utöva
Andra studie-ID-nummer
- RBHP 2020 JULIAN
- 2020-A03567-32 (Annan identifierare: 2020-A03567-32)
Läkemedels- och apparatinformation, studiedokument
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