Study of the Effect of Capsinoid Supplementation on Brown Adipose Tissue in Obese Adolescents (ADOBAT)

University of Avignon

Status: Enrolling

Conditions: Diet Modification; Obese Adolescents; Dietary Supplement; Exercise

Treatments: Dietary Supplement: capsinoid supplementation; Other: Control group (placebo)

Study type: Interventional

Funder types: Other

Identifiers

NCT06916208

2024-A02660-47 (Other Identifier)

AU_ISP1_2025

Details and patient eligibility

About

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.

Enrollment: 38 estimated patients

Sex: All

Ages: 11 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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38 participants in 2 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

Adolescents in the control group will receive capsules without active product, but of similar appearance, taste and texture (bought from Ajinomoto® (Ajinomoto Health \& Nutrition North America, Inc., Japan) 3 times per day, representing 9mg/day all through the duration of the 4-week multidimensional care program.

Treatment:

Other: Control group (placebo)

capsinoid supplementation

Experimental group

Description:

dietary supplementation

Treatment:

Dietary Supplement: capsinoid supplementation