A Clinical Trial to Evaluate the Effects of a Supplement on Cognitive Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Change in Cognitive Performance - Digit Span Test
研究概览
简要总结
This is a single-arm, open-label, virtual clinical trial evaluating the cognitive health effects of Auri Super Mushroom Daily Gummies in a population of 35 adult participants over 8 weeks. Participants will consume two gummies daily and complete validated cognitive testing and self-assessment questionnaires to assess changes in cognitive performance, energy, mood, memory, and overall well-being.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be male or female
- •Be aged 30+
- •Anyone who has been experiencing issues consistently for the last four weeks regarding all of the following:
- •Forgetfulness Inability to focus Low energy levels Low mood
- •Anyone who is generally healthy - does not live with any uncontrolled chronic disease
- •Willing to stop any other products or any medication or supplements that target cognition or cognitive health for the study duration
- •Willing to maintain their current diet, sleep schedule, and activity level for the duration of the study
- •Not undergone any surgeries or invasive treatments in the last six months
- •Not had any major illness in the last three months
- •Resides in the United States
- •Not currently partaking in another research study and will not be partaking in any other research study for the next 8 weeks and at any point during this study's duration
- •Willing to consult with their healthcare provider before enrolling in the study if taking any prescription medication
排除标准
- •Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders
- •Anyone with any allergies or sensitivities to any of the study product ingredients
- •Anyone taking immunosuppressants
- •Anyone taking blood thinners (anticoagulants)
- •Any women who are pregnant, breastfeeding, or trying to conceive (or who will be at any point during the study period)
- •Anyone unwilling to follow the study protocol
- •Anyone with a history of substance abuse
- •Anyone with intolerance or sensitivity to mushrooms
结局指标
主要结局
Change in Cognitive Performance - Digit Span Test
时间窗: Baseline, Week 2, Week 4, Week 6, and Week 8
The Digit Span test measures working memory capacity. Participants are presented with a series of numbers and asked to recall them in order. Performance is scored based on the total number of correctly recalled sequences. Scale Name: Digit Span Score Range: 0 to 14 Direction: Higher scores indicate better cognitive performance.
Change in Cognitive Performance - Paired Associates Test
时间窗: Baseline, Week 2, Week 4, Week 6, Week 8
The Paired Associates task assesses memory by asking participants to recall which items were previously paired together. Score is based on the number of correct associations recalled. Scale Name: Paired Associates Score Range: 0 to 12 Direction: Higher scores indicate better cognitive performance.
Change in Attention and Processing Speed - Double Trouble Task
时间窗: Baseline, Week 2, Week 4, Week 6, Week 8
Double Trouble is a Stroop-like task that measures attention control and response inhibition. Performance is measured by accuracy (%) and completion time (seconds). Scale Name: Double Trouble Accuracy (%) Range: 0 to 100 Direction: Higher percentage indicates better attention and cognitive control.
次要结局
- Self-Reported Focus - Questionnaire Score(Baseline, Week 2, Week 4, Week 6, and Week 8)
- Self-Reported Memory - Questionnaire Score(Baseline, Week 2, Week 4, Week 6, and Week 8)