- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT07766564
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.
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Tanulmány típusa
Beiratkozás (Tényleges)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi helyek
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Nevada
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Las Vegas, Nevada, Egyesült Államok, 89101
- Citruslabs
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
Egészséges önkénteseket fogad
Leírás
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
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Egyéb
- Kiosztás: N/A
- Beavatkozó modell: Egyetlen csoportos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Kísérleti: 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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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Change in Cognitive Assessment Score (Polygons)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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
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Change in Cognitive Assessment Score (Paired Associates)
Időkeret: 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)
Időkeret: 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)
Időkeret: Baseline, Week 2, Week 4, and Week 6
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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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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Change in Self-Reported Focus
Időkeret: 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
Időkeret: Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
|
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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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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Együttműködők és nyomozók
Szponzor
Együttműködők
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Egyéb vizsgálati azonosító számok
- 20807 (Egyéb azonosító: Fred Hutch/University of Washington Cancer Consortium)
- legacy-20807
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
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