NCT02518165已完成不适用
A Randomized, Double-Blind, Placebo-Controlled, Parallel Trial to Assess the Effects of A Proprietary Spearmint Extract on Cognitive Performance, Mood, and Sleep in Men and Women
Kemin Foods LC2 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2015年4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
- 已完成
- 发起方
- 入组人数
- 142
- 试验地点
- 2
- 主要终点
- Choice reaction time as assessed by the Makoto Arena Device
研究概览
简要总结
This study was designed to evaluate the chronic effects of a proprietary spearmint extract over 90 days of supplementation on aspects of cognitive performance (cognitive function and active reaction time), subjective mood, and sleep quality in healthy men and women.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Men and pre-menopausal women, 18-50 years of age.
- •Body mass index 18.5-29.99 kg/m2, inclusive or body mass index 30.0-34.99 kg/m2 and body fat via bioimpedance <39% for women aged 18-39y, <40% for women aged 40-50y, <25% for men aged 18-39y, <28% for men aged 40-50y.
- •Participant has at least a high school diploma or the equivalent.
- •Participant is recreationally active.
- •Participant is judged by the Investigator to be in general good health.
- •Participant understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigators.
排除标准
- •Participant is unable to understand and/or perform required tests.
- •Participant is unwilling to maintain normal dietary (including vitamins and supplements), exercise, sleep and medication patterns throughout the study.
- •Participant is a habitual consumer of mint tea defined as >8oz per day.
- •Participant is regularly taking a cognitive enhancing supplement.
- •Participant has a history or presence of a clinically important cardiac, renal, hepatic, endocrine, pulmonary, biliary, gastrointestinal, pancreatic, or neurologic disorder.
- •Participant has a sleep disorder or occupation where sleep during the overnight hours is irregular.
- •Participant is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period.
- •Participant is a current user of tobacco (defined as tobacco use within the previous 6 months).
研究组 & 干预措施
Proprietary spearmint extract
Active Comparator
Subjects randomized into the active treatment group will be asked to consume 900 mg/day of the proprietary spearmint extract.
干预措施: Proprietary spearmint extract (Dietary Supplement)
Microcrystalline cellulose
Placebo Comparator
Subjects randomized into the placebo group will be asked to consume 900 mg/day of the excipient, microcrystalline cellulose.
干预措施: Placebo (Other)
结局指标
主要结局
Choice reaction time as assessed by the Makoto Arena Device
时间窗: Change from baseline after 90 days of supplementation
次要结局
- Cognitive function (speed, reaction time, attention, executive function, memory, and motor speed) as assessed by a computerized test battery(Change from baseline after 90 days of supplementation)
- Subjective mood as assessed using a Likert scale questionnaire(Change from baseline after 90 days of supplementation)
- Subjective sleep quality and efficiency as assessed using Likert and visual analog scale questionnaires(Change from baseline after 90 days of supplementation or between group comparisons at day 90.)
研究者
研究点 (2)
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