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

NCT06916208 | Recruiting

• 2 other identifiers: AU_ISP1_20252024-A02660-47
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Exercise; Diet Modification; Dietary Supplement; Obese Adolescents

Outcome Measures

Primary Outcomes (1)

• Temperature variation between supra-clavicular region and sternal control region pre-post cold stimulus.

  Temperature variation between supra-clavicular region and sternal control region pre-post cold stimulus, in °c. This temperature variation is evaluated using an infrared thermal camera (FLIR) during a cold test.

  at inclusion, and at the end of the 4-week program

Secondary Outcomes (12)

• Changes in cutaneous perfusion

  at inclusion, and at the end of the 4-week program

• Resting metabolism

  at inclusion, and at the end of the 4-week program

• Frequency components of heart rate

  at inclusion, and at the end of the 4-week program

• Temporal components of heart rate

  at inclusion, at the end of the 4-week program

• Glycemic profile

  at inclusion, at the end of the 4-week program

Study Arms (2)

Control group

PLACEBO COMPARATOR

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.

Other: Control group (placebo)

capsinoid supplementation

EXPERIMENTAL

dietary supplementation

Dietary Supplement: capsinoid supplementation

Interventions

capsinoid supplementation DIETARY_SUPPLEMENT

Adolescents in the experimental group will receive active capsules containing dihydrocapsiate (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.

capsinoid supplementation

Control group (placebo) OTHER

Regular multidimensional care 4-week program

Control group

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• known allergy to capsinoids and/or soya
• inflammatory digestive pathology and/or history of digestive tract surgery
• 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.

Sponsors & Collaborators

• University of Avignon: lead
• Institut Saint Pierre: collaborator

Study Sites (1)

Institut Saint Pierre

Palavas-les-Flots, France

RECRUITING

Related Publications (6)

• 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.

  PMID: 30624591 RESULT

• 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.

  PMID: 38402434 RESULT

• 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.

  PMID: 29119565 RESULT

• 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.

  PMID: 21168855 RESULT

• 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.

  PMID: 19357406 RESULT

• 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.

  PMID: 24165204 RESULT

Related Links

• opinion of the French National Agency for Food, Environmental and Occupational Health Safety

MeSH Terms

Conditions

Motor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Agnès VINET

CONTACT

+33 4 13 95 13 44; agnes.vinet@univ-avignon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: April 8, 2025
• Study Start: March 3, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)