NCT05541887

Use Muscadine Wine Nutraceuticals to Improve Brain Health, Cognition, and Mental Health

Acute and Chronic Impacts of Muscadine Wine Polyphenols on Cognition, Memory, Mood, and Anxiety in Adults Over 50 Years of Age

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 50 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

Although the exact biological mechanisms for depression and Alzheimer's Disease are not fully understood, it's believed that they are caused by a combination of factors. An increasing amount of scientific research has proposed several possible pathophysiologies linking depression and AD. For example, increased production of pro-inflammatory cytokines in the nervous system, oxidative stress induced by chronic inflammation leads to dysregulation of the hypothalamic-pituitary-adrenal (HPA) axis, and disturbance in the brain-derived neurotrophic factor signal pathway. Polyphenol has been well recognized for its antioxidant and anti-inflammatory properties. Previous studies have shown that polyphenol-rich food such as concord grape juice, blueberries, blackcurrants, and green oats positively affect cognition, memory, and mood in humans. However, no one has examined the effects of muscadine wine polyphenol on cognitive and mental health. In addition, if they do have effects, through what mechanism? This clinical trial will allow us to investigate the questions raised. We hypothesize that intake of muscadine wine polyphenols enhances cognition and memory and improve depression and anxiety in healthy adults over 50 year-old via regulating the HPA axis, alleviating inflammation and oxidative stress, and/or inhibiting monoamine oxidase activities. The research will provide the first clinical evidence of how muscadine wine polyphenols affect the brain and mental health.

Conditions

• Cognitive Performance
• Memory
• Mood
• Anxiety

Interventions

Type	Name	Description
OTHER	Muscadine Wine Polyphenol	dealcoholized muscadine wine with alcohol content \<0.5% with addition of 50ppm of sodium metabisulfite for preservation
OTHER	Placebo	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

Timeline

• Start date: 2023-08-30
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2022-09-15
• Last updated: 2025-06-12

Locations

1 site across 1 country: United States