NCT02493140Unknown不适用
Evaluation of Efficacy and Safety of a Cashew Apple Extract on Weight Management and Associated Metabolic Risk Factors in Overweight/Obese Volunteers: a Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial
Dialpha1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2015年7月1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
- 66
- 试验地点
- 1
- 主要终点
- Body weight reduction
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of a cashew apple extract on weight management and associated metabolic risk factors in overweight/obese volunteers, versus placebo, after 12 weeks of treatment.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •27 ≤ BMI ≤ 35 kg/m²
- •Abdominal obesity
- •Acceptance to adhere to diet and physical activity recommendations while maintaining global lifestyle habits
- •Stable body weight (<5% variation) within the last 3 months prior to screening
排除标准
- •Allergy to nuts and products thereof and allergy to mango fruit
- •Type I or II diabetes
- •Severe chronic diseases
- •History of bariatric surgery and eating disorders
- •Use of weight management products or medications which could affect nutrients absorption, lipids or carbohydrates metabolism
研究组 & 干预措施
Cashew apple extract (Cashewin)
Active Comparator
干预措施: Cashew apple extract (Cashewin) (Dietary Supplement)
Placebo
Placebo Comparator
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Body weight reduction
时间窗: 12 weeks
次要结局
- Waist and hip circumferences variation(6 and 12 weeks)
- Fasting glycemia variation(12 weeks)
- Fasting insulinemia variation(12 weeks)
- HOMA-IR index variation(12 weeks)
- Body weight variation(6 weeks and 12 weeks)
- Body fat variation(6 and 12 weeks)
- BMI variation(6 and 12 weeks)
- Blood lipids (total cholesterol, HDL, LDL, triglycérides) variation(12 weeks)
- CRPus variation(12 weeks)
- Variation of glycemia 2h post glucose solution intake(12 weeks)
- Systolic and diastolic blood pressure variation(6 and 12 weeks)
- Safety (blood parameters measurements: urea, creatinine, ASAT, ALAT) with adverse events recording(12 weeks)
研究者
研究点 (1)
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