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

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.

Study Overview

• Status: Recruiting
• Conditions: Diet Modification; Exercise; Dietary Supplement; Obese Adolescents
• Intervention / Treatment: Other: Control group (placebo); Dietary supplement: capsinoid supplementation

• Study Type: Interventional
• Enrollment (Estimated): 38
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Agnès VINET; Phone Number: +33 4 13 95 13 44; Email: agnes.vinet@univ-avignon.fr

Study Locations

• France
  • Palavas-les-Flots, France
    • Recruiting
    • Institut Saint Pierre
    • Contact: Claire-Lise Gay, MD; Phone Number: +33 4 67 07 75 00; Email: gay.c@institut-st-pierre.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group; 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); Regular multidimensional care 4-week program
Experimental: capsinoid supplementation; dietary supplementation	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in cutaneous perfusion	Cutaneous perfusion is measured in the supra-clavicular region using laser-doppler flowmetry, in PU (perfusion units)	at inclusion, and at the end of the 4-week program
Resting metabolism	Resting metabolism is measured using indirect calorimetry (ErgoCard CPX and off-line analyses based on Weir equations, in kcal/h and kcal/h/kg	at inclusion, and at the end of the 4-week program
Frequency components of heart rate	High frequence, Low frequency (and High/low frequency ratio), in ms² and %	at inclusion, and at the end of the 4-week program
Temporal components of heart rate	Time-domain metrics used to assess autonomic nervous system function: SDNN Standard Deviation of NN intervals, in ms; Root Mean Square of Successive Differences, in ms; Percentage of NN50 Intervals, in %	at inclusion, at the end of the 4-week program
Glycemic profile	glucose concentration, in mmol/ and insulin concentration, in μg/mL, from blood test, combined to calcultate the HOMA-IR, an insulin resistance index as [Fasting Insulin (μg/mL)]*[Fasting Glucose (mmol/L)]/22.5	at inclusion, at the end of the 4-week program
Lipid profile	triglycerides concentration, in mg/dL; total and HDL cholestérol, mg/dL, from blood test	at inclusion, at the end of the 4-week program
Catecholamines	catecholamines concentration from blood, ng/L	at inclusion, and at the end of the 4-week program
brown adipose tissue biomarkers	irisin, 12-diHOME, 13-diHOME, FG, BMP4, BMP7 concentration from blood test, in ng/L	at inclusion, and at the end of the 4-week program
Anthropometry	Height, Body mass, in kg and z score, used to calcule the body mass index (BMI, in kg/m2) as body mass/height*height. Fat mass is measured in kg, reported to the body mass in % and to the predicted body surface area to calculate the fat mass index (in kg/m2), body surface area being predicted from the height and body mass.	at inclusion, and at the end of the 4-week program
Eating behavior	Scores for cognitive restraint, uncontrolled eating and emotional eating from the TFEQ21	at inclusion, and at the end of the 4-week program
Treatment compliance	The amount of capsules ingested is quantified through a diary filled by nurses in charge of capsules dispensing, and reported in % of the theoretical 3/day	all through the 4-week program
Pubertal development	Stage of pubertal development using Tanner classification, filled by the medical practioner in charge of inclusion	at inclusion

Collaborators and Investigators

• Sponsor: University of Avignon
• Collaborators: Institut Saint Pierre

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: March 21, 2025
• First Submitted That Met QC Criteria: March 31, 2025
• First Posted (Actual): April 8, 2025

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Motor Activity; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Control Groups
• Other Study ID Numbers: AU_ISP1_2025; 2024-A02660-47 (Other Identifier: French National Agency for Drug and Health Product Safety)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No