Dietary Supplement, Diet Modification, Exercise, Obese Adolescents
Conditions
Brief 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. 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.
Interventions
DIETARY_SUPPLEMENTcapsinoid 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
Sponsors
University of Avignon
Institut Saint Pierre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
11 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Temperature variation between supra-clavicular region and sternal control region pre-post cold stimulus. | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in cutaneous perfusion | 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) |
| Resting metabolism | 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 |
| Frequency components of heart rate | at inclusion, and at the end of the 4-week program | High frequence, Low frequency (and High/low frequency ratio), in ms² and % |
| Temporal components of heart rate | 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 % |
| Glycemic profile | 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 |
| Lipid profile | at inclusion, at the end of the 4-week program | triglycerides concentration, in mg/dL; total and HDL cholestérol, mg/dL, from blood test |
| Catecholamines | at inclusion, and at the end of the 4-week program | catecholamines concentration from blood, ng/L |
| brown adipose tissue biomarkers | 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 |
| Anthropometry | 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. |
| Eating behavior | at inclusion, and at the end of the 4-week program | Scores for cognitive restraint, uncontrolled eating and emotional eating from the TFEQ21 |
| Treatment compliance | 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 |
| Pubertal development | at inclusion | Stage of pubertal development using Tanner classification, filled by the medical practioner in charge of inclusion |
Countries
France
Contacts
CONTACTAgnès VINET
Outcome results
None listed