Effects of L-Theanine and Hericium Erinaceus-Enriched Gummies on Psychological, Cognitive, and Sleep Quality in University Students: An 8-Week Randomized Controlled Trial (THEA-HEAL Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 1
研究概览
简要总结
The THEA-HEAL Trial is an 8-week randomized controlled study investigating the effects of a daily gummy supplement containing L-theanine and Hericium erinaceus (Lion's mane mushroom) extract on stress, anxiety, cognitive performance, and sleep quality in university students in Malaysia. University life can be a stressful period associated with increased psychological distress, sleep problems, and difficulty concentrating.
In this study, eligible participants aged 18-25 years were randomly assigned to either receive the active gummy supplement or no supplementation. The intervention group consumed gummies twice daily, providing a total daily dose of 180 mg L-theanine and 300 mg H. erinaceus extract.
The main purpose of the study is to determine whether this nutraceutical combination can help reduce stress and anxiety and improve cognitive function and sleep quality compared with no supplementation. Additional outcomes include physical activity levels and dietary intake. Findings from this study may provide evidence on the potential role of functional food-based supplements in supporting mental well-being and cognitive health in young adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Malaysian male and female university students aged 18-25 years
- •Reporting moderate levels of stress and/or anxiety
- •Not regularly using cognitive-enhancing supplements in the past 3 months
排除标准
- •Pregnancy or breastfeeding
- •Presence of chronic medical conditions that could affect study outcomes
- •Substance abuse or high caffeine intake (>400 mg/day)
- •Current use of medications or supplements that may influence stress or cognitive function (e.g., antidepressants or nootropics) in the past 3 months
- •Known allergies or hypersensitivity to L-theanine or Hericium erinaceus
研究者
Shi Hui Cheng
Principle Investigator, Assistant Professor, Programme Director Bsc (Hons) Nutrition
University of Nottingham Malaysia