Effects of Capsimax on Appetite, Energy Intake and Blood Pressure
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Change from Baseline in Body weight and fat at Week 12
研究概览
简要总结
Obesity is an ongoing major public health problem in most countries of the world for which the agrifood industry still remains criticized because of the abundant offer of high sugar-lipid-energy dense foods, particularly in the fast-food sector. The resulting societal pressure on the food industry probably explains in part the efforts that have been deployed to seek natural active ingredients and to develop functional foods favorably influencing energy balance. Capsaicin is a food non-nutrient constituent that was shown to decrease appetite sensations and subsequent energy intake. The measurement of heart rate variability revealed an association between the increase in sympathetic nervous system (SNS) activity and the satiating effects induced by capsaicin. This is concordant with the observation that pre-prandial intake of capsaicin, be it in capsules or diluted in tomato juice, increased satiety and reduced energy intake.
The objective of this study is to evaluate the long effects of Capsimax on appetite sensations and energy expenditure under conditions of moderate energy restriction and to evaluate the long-term effects of Capsimax on energy intake and expenditure under conditions of moderate energy restriction.
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
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Premenopausal women
- •Between 18 and 50 years
- •Non-smoker
- •BMI between 25 and 35 kg/m2
- •Weight stability
排除标准
- •Pregnant or menopausal woman
- •History of losing and gaining weight (yo-yo)
- •Taking medication for diabetes, hypertension, depression, or hypothyroid
- •Taking a supplement for weight loss
- •Vegetarian, vegan, intolerant to gluten or pepper (investigational product), and severe allergy to peanuts or nuts
- •Suffers from Irritable Bowel Syndrome or gastro-oesophageal reflux
- •Suffers from stomach ulcers or inflammation
- •Other serious conditions such as cardiovascular, renal, liver, and lung diseases
- •History of drug abuse and current alcohol abuse
- •Use of any medication (including over-the-counter medications and herbal remedies) such as grapefruit juice, piperine, NSAIDs, etc.
研究组 & 干预措施
Capsimax
干预措施: Capsimax (Drug)
Capsimax
干预措施: Energy restriction (Other)
Placebo
Placebo, 2 capsules per day, for 12 weeks
干预措施: Energy restriction (Other)
结局指标
主要结局
Change from Baseline in Body weight and fat at Week 12
时间窗: 12 weeks
Body weight and fat measured with Dual-energy X-ray absorptiometry (DXA)
Change from Baseline in appetite sensations, energy intake and food preferences at Week 12
时间窗: 12 weeks
Visual analog scales used after a standardized breakfast and a buffet-type meal to measure hunger, fullness, satiety and desire to eat.
Change from Baseline in Blood pressure at Week 12
时间窗: 12 weeks
Blood pressure measured every 30 minutes during a 3h testing
Change from Baseline in energy expenditure at Week 12
时间窗: 12 weeks
Energy expenditure measured at fasting stade, after a 15 minutes rest, by indirect calorimetry
次要结局
- Change from Baseline sleeping quality (PSQI) at Week 12(12 weeks)
- Change from Baseline anxiety (BDI and STAI) at Week 12(12 weeks)
- Change from Baseline Microbiota analysis at Week 12(12 weeks)
- Change from Baseline System analysis of endocannabinoids at Week 12(12 weeks)
- Change from Baseline Feeding behaviors (TFEQ and Food cravings questionnaire) at Weeks 12(12 weeks)