A Double-blind, Randomized, Placebo Controlled Study of the Effect of Red Grape Cells (RGC) Powder Consumption on Measures of Aerobic Fitness, Body Composition and Mood
概览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Fruitura Bioscience Ltd.
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- changes in aerobic fitness
概览
简要总结
This is a 3-arm double blind placebo controlled study to investigate the effect of Red Grape Cell (RGC) powder containing all the matrix of polyphenols that can be found in red grapes. polyphenols have several beneficial effects on various body systems, are present in many edible foods, and are considered safe for human consumption by regulatory authorities. Animal and human studies suggest a potential for polyphenol-rich compounds in enhancing mitochondrial activity and exercise capacity. However, the effect of RGC on exercise performance in humans had not yet been tested. A special population where increasing performance is highly sought are competitive athletes. The aim of the current study is to investigate the effect of RGC on measures of aerobic fitness, body composition and mood in trained male cyclists
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age 18 - 65 years, men only
- •Active in cycling training group
- •Willingness to avoid regular use of NSAIDS (Advil, Nurofen, etc.) and aspirin for the entire study period
- •Without a history or evidence of significant cardiovascular, hepatic, renal, respiratory, hematopoietic, gastrointestinal disease, endocrine, metabolic, psychiatric or psychological disorders;
- •Willingness to avoid regular ingestion of any foods containing peanuts, bilberries, blueberries, cranberries, strawberries, raspberries, grapes, grape juice, cocoa powder, dark chocolate, red wine, over-the-counter medications, herbs, or supplements throughout the entire study, and to record and report any occasional consumption of such substances
排除标准
- •Any acute medical situation (e.g., acute infection, nausea and vomiting, diarrhea) 48 hours prior to initiation of the study, which is considered of significance by the principal investigator.
- •Any known chronic medical condition (will be determined by the principal investigator)
- •History or evidence of alcohol or drug abuse
- •Any gastrointestinal surgery other than appendectomy or herniotomy;
- •Current use of over the counter or prescription weight loss medication
- •Current use or within the last 30 days, any cholesterol lowering medications (statins, fibrates, red yeast rice, niacin).
- •Known allergy to casein and/or soy.
- •Subjects who had participated in a drug trial 3 months before initiation of the study;
- •Non-cooperative subjects or unwilling to sign an informed consent and participate in the study
结局指标
主要结局
changes in aerobic fitness
时间窗: baseline and 6 weeks
次要结局
- Changes in Body Mass Index (BMI)(baseline and 6 weeks)
- Changes in body weight(baseline and 6 weeks)
- Changes in mood(baseline and 6 weeks)
- Changes in body composition(baseline and 6 weeks)