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

University of Florida

Status: Enrolling

Conditions: Mood; Cognitive Performance; Anxiety; Memory

Treatments: Other: Placebo; Other: Muscadine Wine Polyphenol

Study type: Interventional

Funder types: Other

Identifiers

NCT05541887

IRB202300014

Details and patient eligibility

About

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

Full 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.

Enrollment: 25 estimated patients

Sex: All

Ages: 50 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy
• BMI (18.5-29.9)
• Body weight ≥110 pounds

Exclusion criteria

• Pregnancy
• Breast-feeding
• Smokers
• Diabetic
• Heavy drinkers
• Subjective but not clinically diagnosed cognitive impairment (Montreal cognitive assessment score <26),
• Inability to understand the cognitive function tasks
• Intake of medication that might influence the outcome of the study (e.g. psychostimulant)
• cannabis product user
• Clinically diagnosed mental illnesses
• Cardiovascular and neurological disorders
• Uncontrolled hypertension

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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25 participants in 2 patient groups

Intervention-Placebo

Active Comparator group

Description:

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

Treatment:

Other: Muscadine Wine Polyphenol

Other: Placebo

Placebo-Intervention

Active Comparator group

Description:

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

Treatment:

Other: Muscadine Wine Polyphenol

Other: Placebo