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.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Nevada
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Las Vegas、Nevada、アメリカ、89101
- Citruslabs
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-
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:他の
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:BrainJuice Supplement
|
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.
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Cognitive Assessment Score (Polygons)
時間枠:Baseline, Week 2, Week 4, and Week 6
|
Mean change in Polygons processing test score from Baseline, measured via computerized cognitive assessment
|
Baseline, Week 2, Week 4, and Week 6
|
|
Change in Cognitive Assessment Score (Double Trouble)
時間枠: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
|
Baseline, Week 2, Week 4, and Week 6
|
|
Change in Cognitive Assessment Score (Feature Match)
時間枠: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
|
Baseline, Week 2, Week 4, and Week 6
|
|
Change in Cognitive Assessment Score (Paired Associates)
時間枠:Baseline, Week 2, Week 4, and Week 6
|
Mean change in Paired Associates memory task score from Baseline, measured via computerized cognitive assessment
|
Baseline, Week 2, Week 4, and Week 6
|
|
Change in Cognitive Assessment Score (Digit Span)
時間枠: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
|
Baseline, Week 2, Week 4, and Week 6
|
|
Change in Cognitive Assessment Score (Spatial Planning)
時間枠:Baseline, Week 2, Week 4, and Week 6
|
Mean change in Spatial Planning executive function test score from Baseline, measured via computerized cognitive assessment
|
Baseline, Week 2, Week 4, and Week 6
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Self-Reported Focus
時間枠:Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
|
Mean change in perceived focus from Baseline, assessed via self-reported questionnaire
|
Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
|
|
Change in Self-Reported Attention
時間枠:Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
|
Mean change in perceived attention from Baseline, assessed via self-reported questionnaire
|
Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
|
|
Change in Self-Reported Concentration
時間枠:Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
|
Mean change in perceived concentration from Baseline, assessed via self-reported questionnaire
|
Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
|
|
Change in Self-Reported Productivity
時間枠:Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
|
Mean change in perceived productivity from Baseline, assessed via self-reported questionnaire
|
Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
|
|
Change in Self-Reported Alertness
時間枠:Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
|
Mean change in perceived alertness from Baseline, assessed via self-reported questionnaire
|
Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
|
|
Change in Self-Reported Mental Clarity
時間枠:Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
|
Mean change in perceived mental clarity from Baseline, assessed via self-reported questionnaire
|
Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
|
|
Change in Self-Reported Mood
時間枠:Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
|
Mean change in perceived mood from Baseline, assessed via self-reported questionnaire
|
Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
|
|
Change in Self-Reported Mental Fatigue
時間枠:Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
|
Mean change in perceived mental fatigue from Baseline, assessed via self-reported questionnaire
|
Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
|
|
Change in Self-Reported Motivation
時間枠:Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
|
Mean change in perceived motivation from Baseline, assessed via self-reported questionnaire
|
Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
|
|
Change in Self-Reported Organization
時間枠:Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
|
Mean change in perceived organization from Baseline, assessed via self-reported questionnaire
|
Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
|
協力者と研究者
スポンサー
協力者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 20807 (その他の識別子:Fred Hutch/University of Washington Cancer Consortium)
- legacy-20807
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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