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NCT Number: NCT06916208

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

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.

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Key information

Conditions

Obese Adolescents Behavior Diet Modification Dietary Supplement Exercise Motor Activity

Age range

11 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Control group (placebo)

Other

Regular multidimensional care 4-week program

Primary outcomes

  1. 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

    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.

Secondary outcomes

  1. Changes in cutaneous perfusion

    Time frame: at inclusion, and at the end of the 4-week program

    Cutaneous perfusion is measured in the supra-clavicular region using laser-doppler flowmetry, in PU (perfusion units)

  2. Resting metabolism

    Time frame: at inclusion, and at the end of the 4-week program

    Resting metabolism is measured using indirect calorimetry (ErgoCard CPX and off-line analyses based on Weir equations, in kcal/h and kcal/h/kg

  3. Frequency components of heart rate

    Time frame: at inclusion, and at the end of the 4-week program

    High frequence, Low frequency (and High/low frequency ratio), in ms² and %

  4. Temporal components of heart rate

    Time frame: at inclusion, at the end of the 4-week program

    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 %

  5. Glycemic profile

    Time frame: at inclusion, at the end of the 4-week program

    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

  6. Lipid profile

    Time frame: at inclusion, at the end of the 4-week program

    triglycerides concentration, in mg/dL; total and HDL cholestérol, mg/dL, from blood test

  7. Catecholamines

    Time frame: at inclusion, and at the end of the 4-week program

    catecholamines concentration from blood, ng/L

  8. brown adipose tissue biomarkers

    Time frame: at inclusion, and at the end of the 4-week program

    irisin, 12-diHOME, 13-diHOME, FG, BMP4, BMP7 concentration from blood test, in ng/L

  9. Anthropometry

    Time frame: at inclusion, and at the end of the 4-week program

    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.

  10. Eating behavior

    Time frame: at inclusion, and at the end of the 4-week program

    Scores for cognitive restraint, uncontrolled eating and emotional eating from the TFEQ21

  11. Treatment compliance

    Time frame: all through the 4-week program

    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

  12. Pubertal development

    Time frame: at inclusion

    Stage of pubertal development using Tanner classification, filled by the medical practioner in charge of inclusion

Study contacts

Contact information is provided by the study sponsor or research team.

Agnès VINET

CONTACT

[email protected]

+33 4 13 95 13 44

Sponsors and collaborators

Lead sponsor

University of Avignon

Other

Collaborators

  • Institut Saint Pierre

Registry information

Acronym: ADOBAT

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 8, 2025
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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