A Clinical Trial to Evaluate the Effects of Two Supplements on Cognitive Function, Cognitive Performance, and Mood
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Cognitive Assessment Score (Polygons)
研究概览
简要总结
This study evaluates the effects of two liquid dietary supplements, BrainJuice Peach Mango (test product one) and BrainJuice ACTIVE Pomegranate Acai (test product two), on cognitive function, cognitive performance, and mood in healthy adults aged 18-57 who report concerns in these areas. The trial is a six-week, single-arm, open-label, virtual study enrolling 30 participants.
Participants will consume test product one (2.5 oz once daily) during Weeks 1 and 2, undergo a washout period during Weeks 3 and 4, and then consume test product two (2.5 oz once daily) during Weeks 5 and 6. Cognitive function will be assessed via standardized computerized cognitive assessments at Baseline, Week 2, Week 4, and Week 6, while perceptions of cognitive function, cognitive performance, and mood will be captured through self-reported questionnaires at Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 57 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be male or female
- •Be aged 18-57
- •Anyone experiencing concerns regarding all of the following over the past four weeks: Cognitive Function, Cognitive Performance, and Mood
- •Anyone who is generally healthy - does not live with any uncontrolled chronic disease
- •If taking oral over-the-counter supplements or herbal remedies targeted at cognitive function, cognitive performance, or mood, has been consistently taking these for at least 3 months prior to starting the study, and is willing to maintain this routine for the study duration
- •Anyone who is a regular caffeine consumer without a history of caffeine sensitivity or intolerance
- •Willing to maintain the same diet and exercise regimen consistently throughout the study duration
- •Willing to limit caffeine consumption to one additional serving of caffeine outside of the test product i.e. one cup of brewed coffee (~100 mg), one matcha (~60 mg), two shots of espresso (~120 mg), or one cup of caffeinated tea (~50 mg)
- •Resides in the United States
- •Has access to a computer or tablet device
排除标准
- •Anyone with pre-existing chronic conditions, including but not limited to oncological, uncontrolled hypertension (high blood pressure) or hypotension (low blood pressure), heart disease, diabetes and psychiatric disorders
- •History of neurodegenerative disease (e.g., Alzheimer's, Parkinson's), history of traumatic brain injury (including concussions), stroke, epilepsy, or uncontrolled migraine
- •History of mood disorders, such as depression, bipolar disorder, or seasonal affective disorder
- •History of sleep disorders, such as insomnia, narcolepsy, or sleep apnea
- •Anyone with a job that involves shift work that may be overnight or night hours
- •Planning on introducing any products or any new forms of prescription medication or supplements that target cognitive function, cognitive performance, or mood, for the study duration
- •Anyone with any allergies or sensitivities to any of the study product ingredients
- •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 who is currently a smoker or has been a smoker in the past 3 months
- •Currently partaking in another research study or will be partaking in any other research study at any point during this study's duration
研究组 & 干预措施
BrainJuice Supplement
干预措施: BrainJuice Supplement (Dietary Supplement)
结局指标
主要结局
Change in Cognitive Assessment Score (Polygons)
时间窗: Baseline, Week 2, Week 4, and Week 6
Mean change in Polygons processing test score from Baseline, measured via computerized cognitive assessment
Change in Cognitive Assessment Score (Double Trouble)
时间窗: Baseline, Week 2, Week 4, and Week 6
Mean change in Double Trouble selective attention and processing speed test score from Baseline, measured via computerized cognitive assessment
Change in Cognitive Assessment Score (Feature Match)
时间窗: Baseline, Week 2, Week 4, and Week 6
Mean change in Feature Match focus and processing test score from Baseline, measured via computerized cognitive assessment
Change in Cognitive Assessment Score (Paired Associates)
时间窗: Baseline, Week 2, Week 4, and Week 6
Mean change in Paired Associates memory task score from Baseline, measured via computerized cognitive assessment
Change in Cognitive Assessment Score (Digit Span)
时间窗: Baseline, Week 2, Week 4, and Week 6
Mean change in Digit Span short-term memory and attention test score from Baseline, measured via computerized cognitive assessment
Change in Cognitive Assessment Score (Spatial Planning)
时间窗: Baseline, Week 2, Week 4, and Week 6
Mean change in Spatial Planning executive function test score from Baseline, measured via computerized cognitive assessment
次要结局
- Change in Self-Reported Focus(Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6)
- Change in Self-Reported Attention(Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6)
- Change in Self-Reported Concentration(Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6)
- Change in Self-Reported Productivity(Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6)
- Change in Self-Reported Alertness(Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6)
- Change in Self-Reported Mental Clarity(Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6)
- Change in Self-Reported Mood(Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6)
- Change in Self-Reported Mental Fatigue(Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6)
- Change in Self-Reported Motivation(Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6)
- Change in Self-Reported Organization(Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6)