NCT06916208 Study of the Effect of Capsinoid Supplementation on Brown Adipose Tissue in Obese Adolescents
| NCT ID | NCT06916208 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Avignon |
| Condition | Obese Adolescents |
| Study Type | INTERVENTIONAL |
| Enrollment | 38 participants |
| Start Date | 2025-03-03 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 38 participants in total. It began in 2025-03-03 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Among the new strategies being considered for the treatment of obesity and its metabolic complications, the activation of brown adipose tissue (BAT) from white adipose tissue looks promising. Interest in the study of BAT has increased over the last 5-10 years in response to the discovery of functional BAT in humans. The BAT is a tissue specialized in regulating energy expenditure by producing heat through the oxidation of fatty acids contained in the multiple lipid droplets of brown adipocytes. This adipose tissue does not play a storage role, but rather an anti-obesogenic one, thanks to its high metabolic and energetic activity. In addition to exposure to cold, which is the major physiological inducer of brown adipocytes, it seems that exercise and the intake of "adrenergic" foods can activate the TAB and potentially induce a change from white to brown tissue via the production of adrenalin and myokines. Acute and/or chronic effects of thermogenic food supplements have been reported on BAT activation and energy metabolism. The most conclusive of these involve the capsinoids found in sweet peppers and chillies. Weight loss also improves BAT activation. The BAT has already been identified in children. A decrease in its volume and activity from childhood to adolescence and during puberty has been reported. The main objective of this randomized controlled double-blind study is to investigate the effects of capsinoid dietary supplementation on BAT activity in obese adolescents. Our general working hypothesis is that capsinoid supplementation, combined with dietary management, leads to an increase in BAT activity.
Eligibility Criteria
Inclusion Criteria: * member or beneficiary of a health insurance scheme * aged between 11 and 18 * Body Mass Index Z score corresponding to stage 2 obesity according to the curves of Rolland-Cachera et al., 1991 and an absence of weight loss of more than 5% of the total weight over the last 3 months. * effective contraception (in pubescent females) Exclusion Criteria: * known allergy to capsinoids and/or soya * inflammatory digestive pathology and/or history of digestive tract surgery * participation in another study or in a period of exclusion determined by a previous study * pregnant, parturient or breastfeeding * The holder(s) of parental authority or the adolescent refuse(s) to sign the authorisation or acceptance form, respectively. * It proves impossible to provide the adolescent or parental guardian(s) with informed information.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06916208 clinical trial?
This trial is open to participants of all sexes, aged 11 Years or older, up to 18 Years, studying Obese Adolescents. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06916208 currently recruiting?
Yes, NCT06916208 is actively recruiting participants. Contact the research team at agnes.vinet@univ-avignon.fr for enrollment information.
Where is the NCT06916208 trial being conducted?
This trial is being conducted at Palavas-les-Flots, France.
Who is sponsoring the NCT06916208 clinical trial?
NCT06916208 is sponsored by University of Avignon. The trial plans to enroll 38 participants.