Evaluation of the Effects of Botalys Red Panax Ginseng on Cognitive, Psychological and Emotional Processing in Stressed Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Botalys
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- A decrease of stress level
研究概览
简要总结
This study aims to confirm the positive effect of the Red Panax Ginseng on the cognitive performance and regulation of stress and fatigue in adults with moderate stress level.
详细描述
This study has been designed as a randomized double-blind placebo-controlled interventional study.
One hundred and fifty participants (aged between 18 and 60), presenting a moderate level of perceived stress, were randomly allocated to the control (placebo) or test (ginseng supplement) group. Participants will be supplemented during 3 weeks with those products. Cognitive performance and emotional processing will be measured with tests and questionnaires before (baseline) and at the end (3 weeks) of the intervention. Fasted blood glucose level will be measured in blood before (baseline) and at the end (3 weeks) of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy woman or man, aged of 18 to 60 years (inclusive); I.
- •With a moderate level of perceived stress (PSS scores ranging from 14 to 26); I.
- •Provision of signed and dated informed consent form; I.
- •Stated willingness to comply with all study procedures and availability for the duration of the study; I.
- •Speaking French.
排除标准
- •Subject with severe medical or cognitive problems which, in the opinion of the Principal Investigator, could interfere with the evaluation of the study criteria or with participant safety; E.
- •Subject with a coffee consumption of more than 5 cups per day; E.
- •Subject consuming drugs and/or with historical drug addiction (<5 years); E.
- •Subject with alcohol consumption exceeding 3 glasses of wine per day, or two halves of a beer per day, or one glass of strong alcohol per day; E.
- •Subject undergoing medical treatment which, in the opinion of the Principal Investigator, could interfere with cognitive and emotional processing; E.
- •Subject with type 1 or type 2 diabetes; E.
- •Subject participating in another intervention trial; E.
- •Women of childbearing age who are pregnant or breastfeeding or who wish to become pregnant within the next 6 weeks or who are not using an adequate method of contraception (e.g. oral contraception, IUD, abstinence, ...).
结局指标
主要结局
A decrease of stress level
时间窗: 3 weeks
Comparison between groups of the adjusted for baseline stress level assessed by the Perceived Stress Scale (PSS)
次要结局
- Evolution of executive functions performance(3 weeks)
- Evolution of emotional processing(3 weeks)
- Evolution of fatigue level(3 weeks)
- Evolution of depression state(3 weeks)
- Evolution of anxiety state(3 weeks)
- Evolution of memory performance(3 weeks)
- Evolution of attentional performance(3 weeks)
- The intervention satisfaction of the volunteer(3 weeks)