Obese AdolescentsADOBATNCT06916208
Study of the Effect of Capsinoid Supplementation on Brown Adipose Tissue in Obese Adolescents
A study testing capsinoid supplementation in people with Obese Adolescents and Exercise, run by University of Avignon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Obese Adolescents, Exercise, Diet Modification
- What is being tested?
- capsinoid supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteFrance
- Study dates
- 3 Mar 2025to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Institut Saint Pierre
Palavas-les-Flots
Claire-Lise Gay, MD, +33 4 67 07 75 00, gay.c@institut-st-pierre.fr
About this study
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.
Read more
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
- Obese Adolescents, Exercise, Diet Modification, Dietary Supplement
- Being tested
- capsinoid supplementation, Control group (placebo)
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capsinoid supplementationDietary 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Control group (placebo) |
| capsinoid supplementation | Experimental | dietary supplementation Receives: Dietary Supplement: capsinoid supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at inclusion, and at the end of the 4-week program
Secondary outcomes (12)
Changes in cutaneous perfusion
Cutaneous perfusion is measured in the supra-clavicular region using laser-doppler flowmetry, in PU (perfusion units)
Measured: 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
Measured: 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 %
Measured: 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 %
Measured: 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
Measured: 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
Measured: at inclusion, at the end of the 4-week program
Catecholamines
catecholamines concentration from blood, ng/L
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: all through the 4-week program
Pubertal development
Stage of pubertal development using Tanner classification, filled by the medical practioner in charge of inclusion
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start3 Mar 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Obese AdolescentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Avignon
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Saint Pierre
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06916208
- Sponsor's protocol ID
- AU_ISP1_2025
- Other IDs
- 2024-A02660-47
- Acronym
- ADOBAT
- Status last verified
- Apr 2026
- First submitted
- 21 Mar 2025
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30624591Martins 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.
PubMed 38402434Chondronikola 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.
PubMed 29119565Gilsanz 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.
PubMed 21168855Cypess 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.
PubMed 19357406Chechi 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.
PubMed 24165204
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effect of Capsinoid Supplementation on Brown Adipose Tissue in Obese Adolescents
- ClinicalTrials.gov ID
- NCT06916208
- Acronym / sponsor ID
- ADOBAT / AU_ISP1_2025
- Conditions
- Obese Adolescents, Exercise, Diet Modification, Dietary Supplement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- University of AvignonUniversity, hospital or other
- Collaborators
- Institut Saint Pierre
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Other: Control group (placebo)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. |
| capsinoid supplementation | Experimental | Dietary Supplement: capsinoid supplementationdietary supplementation |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| capsinoid supplementationAdolescents 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. | Dietary supplement | capsinoid supplementation |
| Control group (placebo)Regular multidimensional care 4-week program | Other | Control group |
Primary outcome
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.
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Results publication: PubMed 30624591Osuna-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.
- Results publication: PubMed 38402434Martins 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.
- Results publication: PubMed 29119565Chondronikola 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.
- Results publication: PubMed 21168855Gilsanz 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.
- Results publication: PubMed 19357406Cypess 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.
- Results publication: PubMed 24165204Chechi 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.
- opinion of the French National Agency for Food, Environmental and Occupational Health SafetyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing capsinoid supplementation in people with Obese Adolescents and Exercise, run by University of Avignon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Agnès VINET (+33 4 13 95 13 44, agnes.vinet@univ-avignon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06916208, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.