NCT01155076已完成不适用
Effects of a Proprietary Ginseng, Cordyceps, and Pomegranate Supplement on Physical and Mental Function in Middle-aged Adults: a Double-blind, Randomized, Placebo-controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pharmanex
- 入组人数
- 116
- 试验地点
- 6
- 主要终点
- Health-related quality of life
研究概览
简要总结
The purpose of the study is to determine the effects of 8 weeks Vitality Product supplementation on physical and mental function in middle-aged adults
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females aged 40-70 years
- •Signed Informed Consent
- •BMI between 19 and 30 kg/m2
- •Normotensive, defined as systolic blood pressure 90-140 mmHg and diastolic blood pressure 50-90 mmHg
排除标准
- •Regular dietary supplement use and unwilling to discontinue use at least 1 month prior to enrollment in the study
- •Self-reported chronic condition that may affect subject safety (e.g. diabetes, cardiovascular disease) or significantly impact product effectiveness (e.g. chronic fatigue)
- •Pregnancy/suspected pregnancy, breastfeeding
- •Antihypertensive medication use
- •Allergies to any supplement ingredients
- •Consumption of more than 600mg caffeine from any source per day
- •Consumption of "energy drinks" (e.g. Red Bull, Monster) or any herbal supplement known to affect energy levels
- •Known iron anemia
- •Medically treated for insomnia
- •Medically treated for depression
- •Taking medications known to affect energy, e.g. thyroid medication
- •Tobacco user
- •Planned surgical procedure in next 2 months
- •Participating in another clinical (medical or nutritional) study or likely to enroll in another medical or nutritional study
结局指标
主要结局
Health-related quality of life
时间窗: 8 weeks
次要结局
- Medical Outcomes Study (MOS) Sexual Function questionnaire(8 weeks)
- Adverse events(8 weeks)
研究者
研究点 (6)
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