Study of the Effect of Capsinoid Supplementation on Brown Adipose Tissue in Obese Adolescents
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age11-18
SponsorUniversity of Avignon
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
capsinoid supplementation
Dietary supplementAdolescents 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 interventionRegular multidimensional care 4-week program
Treatment groups
38 Participants
are divided into 2 treatment groupsGroup A: Control groupPlacebo comparator 1 intervention
Group B: capsinoid supplementationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 programSecondary outcomes
1
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 program2
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 program3
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 program4
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 programSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Avignon
Lead sponsor
Institut Saint Pierre
Collaborator
Source ClinicalTrials.gov