Study of the Effect of Capsinoid Supplementation on Brown Adipose Tissue in Obese Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Temperature variation between supra-clavicular region and sternal control region pre-post cold stimulus.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 11 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
Control group
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.
干预措施: Control group (placebo) (Other)
capsinoid supplementation
dietary supplementation
干预措施: capsinoid supplementation (Dietary Supplement)
结局指标
主要结局
Temperature variation between supra-clavicular region and sternal control region pre-post cold stimulus.
时间窗: 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.
次要结局
- Changes in cutaneous perfusion(at inclusion, and at the end of the 4-week program)
- Temporal components of heart rate(at inclusion, at the end of the 4-week program)
- Resting metabolism(at inclusion, and at the end of the 4-week program)
- Frequency components of heart rate(at inclusion, and at the end of the 4-week program)
- Glycemic profile(at inclusion, at the end of the 4-week program)
- Catecholamines(at inclusion, and at the end of the 4-week program)
- Eating behavior(at inclusion, and at the end of the 4-week program)
- brown adipose tissue biomarkers(at inclusion, and at the end of the 4-week program)
- Treatment compliance(all through the 4-week program)
- Pubertal development(at inclusion)
- Lipid profile(at inclusion, at the end of the 4-week program)
- Anthropometry(at inclusion, and at the end of the 4-week program)