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Recruiting NCT06916208

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

No phase Interventional Obese Adolescents Exercise Diet Modification Dietary Supplement

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: capsinoid supplementation, Control group (placebo).
Who it may be relevant to
Registry conditions: Obese Adolescents, Exercise, Diet Modification, Dietary Supplement. Basic parameters: 11 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Dietary supplement capsinoid supplementation
    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.
  • Other Control group (placebo)
    Regular multidimensional care 4-week program

Primary outcome measures

  • Temperature variation between supra-clavicular region and sternal control region pre-post cold stimulus. [Time frame: at inclusion, and at the end of the 4-week program]
Secondary outcome measures (12)
  • Changes in cutaneous perfusion [Time frame: at inclusion, and at the end of the 4-week program]
  • Resting metabolism [Time frame: at inclusion, and at the end of the 4-week program]
  • Frequency components of heart rate [Time frame: at inclusion, and at the end of the 4-week program]
  • Temporal components of heart rate [Time frame: at inclusion, at the end of the 4-week program]
  • Glycemic profile [Time frame: at inclusion, at the end of the 4-week program]
  • Lipid profile [Time frame: at inclusion, at the end of the 4-week program]
  • Catecholamines [Time frame: at inclusion, and at the end of the 4-week program]
  • brown adipose tissue biomarkers [Time frame: at inclusion, and at the end of the 4-week program]
  • Anthropometry [Time frame: at inclusion, and at the end of the 4-week program]
  • Eating behavior [Time frame: at inclusion, and at the end of the 4-week program]
  • Treatment compliance [Time frame: all through the 4-week program]
  • Pubertal development [Time frame: at inclusion]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

France · 1 center
  • Institut Saint Pierre — Palavas-les-Flots

Publications

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT06916208 · AU_ISP1_2025 · 2024-A02660-47

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗