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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A02660-47 | Other Identifier | French National Agency for Drug and Health Product Safety |
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| Name | Class |
|---|---|
| Institut Saint Pierre | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| capsinoid supplementation | Experimental | dietary supplementation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Agnès VINET | Contact | +33 4 13 95 13 44 | agnes.vinet@univ-avignon.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Saint Pierre | Recruiting | Palavas-les-Flots | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30624591 | Result | 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. | |
| 38402434 |
| Label | URL |
|---|---|
| opinion of the French National Agency for Food, Environmental and Occupational Health Safety | View source |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| Control group (placebo) | Other | Regular multidimensional care 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
| 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 |
| 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. |
| 29119565 | Result | 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. |
| 21168855 | Result | 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. |
| 19357406 | Result | 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. |
| 24165204 | Result | 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. |
| EFSA scientific Opinion on dihydrocapsiate | View source |
| D008722 | Methods |