NCT05543811已完成不适用
The Influence of Food for Special Dietary Use - Spread Enriched With 5-hydroxytryptophan, Theanine and Gamma-aminobutyric Acid on Psychophysiological Functions of Subjects Without Meaningful Organic and Cognitive Disorders
Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2022年9月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- change in cognitive function
研究概览
简要总结
This is a single-centre, single-blind, two-arms, controlled study to assess the efficacy and safety of food for special dietary use enriched with 5-hydroxytryptophan, L-theanine and Gamma-aminobutyric acid in generally healthy subjects with no cognitive disturbances
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •willingness to participate;
- •age of 18-50 years
排除标准
- •pregnancy or breastfeeding;
- •significant somatic or psychological disorders
结局指标
主要结局
change in cognitive function
时间窗: two weeks
change in score by Lurie test
change in cognitive function2
时间窗: two weeks
change in Kraepelin\&Schulte test score
change in functional status
时间窗: two weeks
change in functional status test score
change in anxiety and depression
时间窗: two weeks
change in Beck depression inventory score
次要结局
- change in food's taste monotony(two weeks)
研究者
研究点 (2)
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