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

NCT ID: NCT05541887

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-30
• Study Completion Date: 2026-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Muscadine Wine Polyphenol

Intervention Type: OTHER

dealcoholized muscadine wine with alcohol content \<0.5% with addition of 50ppm of sodium metabisulfite for preservation

Placebo

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Muscadine Wine Polyphenol

Intervention Type: OTHER

dealcoholized muscadine wine with alcohol content \<0.5% with addition of 50ppm of sodium metabisulfite for preservation

Placebo

Intervention Type: 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

Interventions

Muscadine Wine Polyphenol

dealcoholized muscadine wine with alcohol content \<0.5% with addition of 50ppm of sodium metabisulfite for preservation

Intervention Type: 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

Intervention Type: OTHER

Other Intervention Names

Dealcoholized Muscadine Wine

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Liwei Gu, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

Food Science and human nutrition department at University of Florida

Gainesville, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kylee Mai

Role: CONTACT

cmai1@ufl.edu

479-203-8170

Liwei Gu, PhD

Role: CONTACT

Lgu@ufl.edu

Facility Contacts

Kylee Mai

Role: primary

cmai1@ufl.edu

479-203-8170

Liwei Gu, PhD

Role: backup

Lgu@ufl.edu

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Other Identifiers

IRB202300014

Identifier Type: -

Identifier Source: org_study_id