NCT01464385已完成2 期
Nutrition Beverage Tolerance Study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 2
- 主要终点
- Proportion of subjects experiencing neurologic adverse event(s)
研究概览
简要总结
To evaluate the sensations experienced by subjects consuming a nutritional beverage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject ≥ 45 years of age.
- •If female, subject is either postmenopausal for at least 1 year or surgically sterile
- •Subject reports that he/she has not participated in a research study in the last three months.
排除标准
- •Subject has active metabolic or endocrine disease
- •Subject has an autoimmune disorder
- •Subject has a disorder of gastrointestinal tract or any gastrointestinal surgery in past 12 months.
- •Subject has food allergy, celiac disease or intolerance to any of the ingredients in the study products
- •Subject reports history of parasthesia; and/or is currently taking medication/dietary supplements/substances that may cause parasthesia for 4 weeks prior to screening
结局指标
主要结局
Proportion of subjects experiencing neurologic adverse event(s)
时间窗: 2-3 weeks
次要结局
- Proportion of subjects experiencing any adverse event(s).(2-3 Weeks)
研究者
研究点 (2)
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