NCT01953172终止不适用
Exploratory, Double-blind, Randomized, Placebo Controlled Study of AMP-886 in the Elderly
Unilever R&D3 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2013年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 12
- 试验地点
- 3
- 主要终点
- Effects on health status and quality of life
研究概览
简要总结
The study is designed to investigate the effect of AMP886 (alpha-tocotrienol) on health status and quality of life measures, cognitive functioning, oxidative stress, inflammation markers and other symptoms effects on skin, sleep and vision in the elderly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females 65-85 years old
- •ECOG Performance score 0 to 1
- •Body mass index 22-30 kg/m2
- •Body weight >60 kg
- •Habit to consume standard breakfast like toast, bread, butter/margarine, eggs, bacon, cereals with milk
- •Comply with protocol and likely to be compliant with prescribed product
排除标准
- •Renal insufficiency or failure at screening
- •Current or previous positive documented history of any chronic inflammatory state including chronic infection, arthritis, or collagen vascular disorder.
- •Comorbid medical conditions
- •Use of prescription medication for chronic conditions
- •Use of hormone replacement therapy (with the exception of levothyroxine)
- •Uncontrolled hypertension
- •Use of hemostatic agents
- •Hemorrhagic disorder and/or coagulation disorder
- •Clinically important bleeding within 90 days prior to screening visit
- •Fat malabsorption syndromes
- •Constipation and/or abdominal pain/discomfort that require dietary supplements or medical therapy
- •History of smoking within 1 year prior to visit 1.
研究组 & 干预措施
Placebo capsules
Placebo Comparator
Placebo capsules
干预措施: Placebo (Other)
AMP-886 (alpha-tocotrienol) in capsules
Experimental
AMP-886 (alpha-tocotrienol) in capsules
干预措施: AMP-886 (Dietary Supplement)
结局指标
主要结局
Effects on health status and quality of life
时间窗: up to 24 weeks
Objective of this exploratory study is to evaluate the effects of AMP886 on health status
次要结局
未报告次要终点
研究者
研究点 (3)
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