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临床试验/NCT01464385
NCT01464385已完成2 期

Nutrition Beverage Tolerance Study

Abbott Nutrition2 个研究点 分布在 1 个国家目标入组 121 人开始时间: 2011年10月最近更新:
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

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

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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