A Clinical Trial to Evaluate the Effects of Two Supplements on Cognitive Function, Cognitive Performance, and Mood
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.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Nevada
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Las Vegas、Nevada、美国、89101
- Citruslabs
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参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:BrainJuice Supplement
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All participants consume BrainJuice Peach Mango (test product one, 2.5 oz once daily) during Weeks 1 and 2, followed by a washout period during Weeks 3 and 4 with no test product, followed by BrainJuice ACTIVE Pomegranate Acai (test product two, 2.5 oz once daily) during Weeks 5 and 6.
There is no comparator or placebo arm.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Cognitive Assessment Score (Polygons)
大体时间:Baseline, Week 2, Week 4, and Week 6
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Mean change in Polygons processing test score from Baseline, measured via computerized cognitive assessment
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Baseline, Week 2, Week 4, and Week 6
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Change in Cognitive Assessment Score (Double Trouble)
大体时间:Baseline, Week 2, Week 4, and Week 6
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Mean change in Double Trouble selective attention and processing speed test score from Baseline, measured via computerized cognitive assessment
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Baseline, Week 2, Week 4, and Week 6
|
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Change in Cognitive Assessment Score (Feature Match)
大体时间:Baseline, Week 2, Week 4, and Week 6
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Mean change in Feature Match focus and processing test score from Baseline, measured via computerized cognitive assessment
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Baseline, Week 2, Week 4, and Week 6
|
|
Change in Cognitive Assessment Score (Paired Associates)
大体时间:Baseline, Week 2, Week 4, and Week 6
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Mean change in Paired Associates memory task score from Baseline, measured via computerized cognitive assessment
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Baseline, Week 2, Week 4, and Week 6
|
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Change in Cognitive Assessment Score (Digit Span)
大体时间:Baseline, Week 2, Week 4, and Week 6
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Mean change in Digit Span short-term memory and attention test score from Baseline, measured via computerized cognitive assessment
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Baseline, Week 2, Week 4, and Week 6
|
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Change in Cognitive Assessment Score (Spatial Planning)
大体时间:Baseline, Week 2, Week 4, and Week 6
|
Mean change in Spatial Planning executive function test score from Baseline, measured via computerized cognitive assessment
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Baseline, Week 2, Week 4, and Week 6
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Self-Reported Focus
大体时间:Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
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Mean change in perceived focus from Baseline, assessed via self-reported questionnaire
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Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
|
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Change in Self-Reported Attention
大体时间:Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
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Mean change in perceived attention from Baseline, assessed via self-reported questionnaire
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Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
|
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Change in Self-Reported Concentration
大体时间:Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
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Mean change in perceived concentration from Baseline, assessed via self-reported questionnaire
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Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
|
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Change in Self-Reported Productivity
大体时间:Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
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Mean change in perceived productivity from Baseline, assessed via self-reported questionnaire
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Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
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Change in Self-Reported Alertness
大体时间:Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
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Mean change in perceived alertness from Baseline, assessed via self-reported questionnaire
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Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
|
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Change in Self-Reported Mental Clarity
大体时间:Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
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Mean change in perceived mental clarity from Baseline, assessed via self-reported questionnaire
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Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
|
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Change in Self-Reported Mood
大体时间:Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
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Mean change in perceived mood from Baseline, assessed via self-reported questionnaire
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Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
|
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Change in Self-Reported Mental Fatigue
大体时间:Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
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Mean change in perceived mental fatigue from Baseline, assessed via self-reported questionnaire
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Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
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Change in Self-Reported Motivation
大体时间:Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
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Mean change in perceived motivation from Baseline, assessed via self-reported questionnaire
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Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
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Change in Self-Reported Organization
大体时间:Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
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Mean change in perceived organization from Baseline, assessed via self-reported questionnaire
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Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
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合作者和调查者
赞助
合作者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 20807 (其他标识符:Fred Hutch/University of Washington Cancer Consortium)
- legacy-20807
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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