NCT05031702Unknown不适用
Effectiveness of the Assumption of a Supplement Based on the Extract From Camelia Leaf Sinensis on Basal Metabolism and Body Composition in Overweight Women or With Obesity in Postmenopause
Azienda di Servizi alla Persona di Pavia1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2021年3月8日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Changes on energy expenditure
研究概览
简要总结
Camellia Sinensis leaf extract contributes to increasing energy expenditure and calorie consumption by increasing thermogenesis. The purpose of this study is to evaluate the efficacy of Camellia Sinensis on basal metabolism and body composition in overweight women or with obesity in postmenopause.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Postmenopause
- •Overweight or obesity class I-II (Body Mass Index 25-39,9 Kg/m2)
排除标准
- •Changes in heart rhythm
- •Intolerance or allergy to components
- •Obesity class III (Body Mass Index > 40 Kg/m2)
研究组 & 干预措施
Placebo
Placebo Comparator
Tablets of the same size as the active component
干预措施: Placebo (Combination Product)
Dietary supplement
Active Comparator
Extract from Camellia Sinensis leaf
干预措施: Camellia Sinensis leaf extract (Dietary Supplement)
结局指标
主要结局
Changes on energy expenditure
时间窗: Changes from baseline energy expenditure at 4 and at 8 weeks
Basal metabolic rate (Kcal/day)
次要结局
- Changes on anthropometry(Changes from baseline anthropometry at 4 and at 8 weeks)
- Changes on insulin resistance(Changes from baseline insulin resistance at 4 and at 8 weeks)
- Changes on satiety(Changes of satiety through 8 weeks)
- Changes on carbohydrate profile(Changes from baseline carbohydrate profile at 4 and at 8 weeks)
- Changes on incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](Changes from baseline incidence of Treatment-Emergent Adverse Events at 8 weeks)
- Changes on citokine profile(Changes from baseline citokine profile at 4 and at 8 weeks)
- Changes on inflammation(Changes from baseline inflammation at 8 weeks)
- Changes on body composition(Changes from baseline body composition at 4 and at 8 weeks)
- Changes on lipid profile(Changes from baseline lipid profile at 8 weeks)
- Changes on plasma catecholamine profile(Changes from baseline plasma catecholamine profile at 4 and at 8 weeks)
研究者
研究点 (1)
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