Use Muscadine Wine Nutraceuticals to Improve Brain Health, Cognition, and Mental Health
Part of paid clinical trials in Gainesville, Florida.
- Sponsor
- University of Florida
- Study ID
- NCT05541887
- Status
- Recruiting
Conditions
- Anxiety
- Cognitive Performance
- Memory
- Mood
Eligibility Criteria
- Sex
- ALL
- Age
- 50 Years - 65 Years
- Healthy Volunteers
- Accepted
Interventions
- Muscadine Wine Polyphenol — OTHERdealcoholized muscadine wine with alcohol content \<0.5% with addition of 50ppm of sodium metabisulfite for preservation
- Placebo — OTHERthis placebo beverage is formulated with matching sugar and organic acid content to the muscadine wine polyphenol. Food coloring is added to match the color of the intervention. 50ppm of sodium metabisulfite for preservation
Study Details
Previous studies have shown that polyphenol-rich foods can positively affect cognitive functions, memory, and mood in humans. We hypothesize that both acute and chronic intake of muscadine wine polyphenols will improve cognitive performance and mood through regulating the HPA axis, alleviating inflammation and oxidative stress, and/or inhibiting monoamine oxidase activities
Key Dates
- Start date
- Aug 30, 2023
- Status verified
- Jun 2025
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 25 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Active Comparator: Intervention-PlaceboParticipants in this arm will consume muscadine wine polyphenol for six weeks and then placebo for another six weeks. The two phases are separated by a 21-day washout period
- Active Comparator: Placebo-InterventionParticipants in this arm will first consume placebo for six weeks and then muscadine wine polyphenol for another six weeks. The two phases are separated by a 21-day washout period
Primary Outcome Measure
Change from baseline cognitive performance score after intervention/placebo [ Time Frame: Baseline, acute (4-hour post single dose), chronic (end of six week) ]
Central Contacts
- Kylee Mai479-203-8170
- Liwei Gu, PhD
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Food Science and human nutrition department at University of Florida | Gainesville | Florida | 32611 | Liwei Gu, PhD |
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