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 — OTHER
    dealcoholized muscadine wine with alcohol content \<0.5% with addition of 50ppm of sodium metabisulfite for preservation
  • Placebo — OTHER
    this 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-Placebo
    Participants 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-Intervention
    Participants 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

Locations (1)

FacilityCityStateZIPSite coordinators
Food Science and human nutrition department at University of FloridaGainesvilleFlorida32611
Kylee Mai
479-203-8170
Liwei Gu, PhD

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