An interventional study of capsinoid supplementation and Control group (placebo) in Obese Adolescents, Exercise and Diet Modification, sponsored by University of Avignon. Recruiting at 1 site in France. Open to participants aged 11 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-04-30.
Sponsored by University of Avignon · Not applicable, Interventional, and Treatment
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.
9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.
This study's planned enrollment of 38 is below the median of 60 across 8,388 interventional studies indexed under Motor Activity.
Browse Motor Activity studies →University of Avignon is the lead sponsor of 12 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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.
Regular multidimensional care 4-week program
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.
Time frame: at inclusion, and at the end of the 4-week program
Changes in cutaneous perfusion
Cutaneous perfusion is measured in the supra-clavicular region using laser-doppler flowmetry, in PU (perfusion units)
Time frame: 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
Time frame: 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 %
Time frame: 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 %
Time frame: 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
Time frame: 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
Time frame: at inclusion, at the end of the 4-week program
Catecholamines
catecholamines concentration from blood, ng/L
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: all through the 4-week program
Pubertal development
Stage of pubertal development using Tanner classification, filled by the medical practioner in charge of inclusion
Time frame: at inclusion
Plan to share: No
Started Mar 2025 (actual). Primary completion is estimated for Mar 2027, 24 months after the start.
Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's planned 24 months is above that.
Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
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University of Avignon