NCT04149158已完成不适用
Evaluation of Sinetrol® Xpur in Fat Mass Reduction on Overweight and Obese Subjects
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Fytexia
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Change in total body fat percentage loss versus bodyweight
研究概览
简要总结
This study aims to evaluate effects of a 16-week supplementation with a polyphenol rich extract, Sinetrol® Xpur, on fat mass accumulation and body weight management improvement.Subjects were overweight or obese and received polyphenol supplement or placebo. A 4-week follow-up as performed to evaluate its effect after supplementation stop.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •overweight or obese (25 kg.m-2<BMI<42.5kg.m-2)
排除标准
- •metabolic or chronical disease with treatments (i.e.: diabetes, dyslipidemia, thyroiditis, inflammatory disease, immunological disease, infectious disease, asthma, anxiety and depression)
- •food allergy to the ingredients of the product (grapefruit, orange, caffeine, guarana)
- •involved in the prior 6 months in a chronic treatment program, eating disorders history, subjected to weight reduction by surgery
- •start or quit smoking, high alcohol consumption
- •pregnant, breastfeeding, wanting to have a baby,
- •menopausal women
结局指标
主要结局
Change in total body fat percentage loss versus bodyweight
时间窗: week1; week16; week20
次要结局
未报告次要终点
研究者
研究点 (1)
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