- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Nevada
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Las Vegas, Nevada, Stati Uniti, 89101
- Citruslabs
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Cognitive Assessment Score (Polygons)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Self-Reported Focus
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Collaboratori
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- 20807 (Altro identificatore: Fred Hutch/University of Washington Cancer Consortium)
- legacy-20807
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .