Clinical trial NCT06916208: Study of the Effect of Capsinoid Supplementation on Brown Adipose Tissue in Obese Adolescents
Official title: Study of the Effect of Capsinoid Supplementation on Brown Adipose Tissue in Obese Adolescents
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obese Adolescents
Exercise
Diet Modification
Dietary Supplement
Lead sponsor: University of Avignon
Sponsor class: OTHER
Collaborators: name: Institut Saint Pierre
First posted: 2025-04-08
Enrollment: 38
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: Temperature variation between supra-clavicular region and sternal control region pre-post cold stimulus.
timeFrame: at inclusion, and at the end of the 4-week program
Secondary outcomes:
measure: Changes in cutaneous perfusion
timeFrame: at inclusion, and at the end of the 4-week program
measure: Resting metabolism
timeFrame: at inclusion, and at the end of the 4-week program
measure: Frequency components of heart rate
timeFrame: at inclusion, and at the end of the 4-week program
measure: Temporal components of heart rate
timeFrame: at inclusion, at the end of the 4-week program
measure: Glycemic profile
timeFrame: at inclusion, at the end of the 4-week program
measure: Lipid profile
timeFrame: at inclusion, at the end of the 4-week program
measure: Catecholamines
timeFrame: at inclusion, and at the end of the 4-week program
measure: brown adipose tissue biomarkers
timeFrame: at inclusion, and at the end of the 4-week program
measure: Anthropometry
timeFrame: at inclusion, and at the end of the 4-week program
measure: Eating behavior
timeFrame: at inclusion, and at the end of the 4-week program
measure: Treatment compliance
timeFrame: all through the 4-week program
measure: Pubertal development
timeFrame: at inclusion
Other outcomes:
Locations:
city: Palavas-les-Flots
country: France
facility: Institut Saint Pierre
Study officials:
References:
citation: Osuna-Prieto FJ, Martinez-Tellez B, Sanchez-Delgado G, Aguilera CM, Lozano-Sanchez J, Arraez-Roman D, Segura-Carretero A, Ruiz JR. Activation of Human Brown Adipose Tissue by Capsinoids, Catechins, Ephedrine, and Other Dietary Components: A Systematic Review. Adv Nutr. 2019 Mar 1;10(2):291-302. doi: 10.1093/advances/nmy067.
citation: Martins FF, Martins BC, Teixeira AVS, Ajackson M, Souza-Mello V, Daleprane JB. Brown Adipose Tissue, Batokines, and Bioactive Compounds in Foods: An Update. Mol Nutr Food Res. 2024 Mar;68(6):e2300634. doi: 10.1002/mnfr.202300634. Epub 2024 Feb 25.
citation: Chondronikola M, Beeman SC, Wahl RL. Non-invasive methods for the assessment of brown adipose tissue in humans. J Physiol. 2018 Feb 1;596(3):363-378. doi: 10.1113/JP274255. Epub 2018 Jan 15.
citation: Gilsanz V, Chung SA, Jackson H, Dorey FJ, Hu HH. Functional brown adipose tissue is related to muscle volume in children and adolescents. J Pediatr. 2011 May;158(5):722-6. doi: 10.1016/j.jpeds.2010.11.020. Epub 2010 Dec 18.
citation: Cypess AM, Lehman S, Williams G, Tal I, Rodman D, Goldfine AB, Kuo FC, Palmer EL, Tseng YH, Doria A, Kolodny GM, Kahn CR. Identification and importance of brown adipose tissue in adult humans. N Engl J Med. 2009 Apr 9;360(15):1509-17. doi: 10.1056/NEJMoa0810780.
citation: Chechi K, Nedergaard J, Richard D. Brown adipose tissue as an anti-obesity tissue in humans. Obes Rev. 2014 Feb;15(2):92-106. doi: 10.1111/obr.12116. Epub 2013 Oct 25.