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

June 9, 2025 updated by: University of Florida

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Kylee Mai
  • Phone Number: 479-203-8170
  • Email: cmai1@ufl.edu

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32611
        • Recruiting
        • Food Science and human nutrition department at University of Florida
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

46 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Other: Muscadine Wine Polyphenol
dealcoholized muscadine wine with alcohol content <0.5% with addition of 50ppm of sodium metabisulfite for preservation
Other Names:
  • Dealcoholized Muscadine Wine
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
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
Other: Muscadine Wine Polyphenol
dealcoholized muscadine wine with alcohol content <0.5% with addition of 50ppm of sodium metabisulfite for preservation
Other Names:
  • Dealcoholized Muscadine Wine
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline cognitive performance score after intervention/placebo
Time Frame: Baseline, acute (4-hour post single dose), chronic (end of six week)
Participants will complete the NIH Toolbox cognitive battery. The test battery incorporates multiple tests that assess various aspects of cognitive performance. The list of tests and the function they measure are the following.1. Flanker inhibitory control and attention test (executive function): scoring is based on a combination of accuracy and reaction time. A 2-vector scoring method is employed that uses accuracy and reaction time, where each of these vectors ranges in value between 0 and 5, and the computed score, combining each vector score, ranges in value 0-10. The higher the score the better the performance. 2. Dimensional Change Card Sort (cognitive flexibility): scoring is the same as Flanker's test.
Baseline, acute (4-hour post single dose), chronic (end of six week)
Change from baseline cognitive performance score after intervention/placebo - continued
Time Frame: Baseline, acute (4-hour post single dose), chronic (end of six week)
3. Picture Sequence Test (episodic memory): Item Response Theory (IRT) is used to score this test. score known as a theta score is calculated for each participant; it represents the relative overall ability or performance of the participant. A theta score is very similar to a z-score, which is a statistic with a mean of zero and a standard deviation of one. The higher the score, the better the performance. 4. List Sorting Test (working memory: scored by summing the total number of items correctly recalled and sequenced on the tests, which can range from 0-26. 5. Pattern and Comparison Test (processing speed): The participant's raw score is the number of items answered correctly in 85 seconds of response time, with a range of 0-130. higher score means better performance. Both individual test scores and composite scores will be compared to baseline score
Baseline, acute (4-hour post single dose), chronic (end of six week)
Change from baseline cognitive performance score after intervention/placebo - continued
Time Frame: Baseline, acute (4-hour post single dose), chronic (end of six week)
6. Rey's Auditory Verbal Learning Test assesses immediate and delayed (30min) recall of a given list of words that is repeated 5 times. The number of correct words recalled and intrusion words (extraneous word offered by the participant that does not appear on the list) are recorded for scoring
Baseline, acute (4-hour post single dose), chronic (end of six week)
Change from baseline monoamine oxidase (MAOs) activity
Time Frame: Baseline, acute (4-hour post single dose), chronic (end of six week)
Blood samples will be drawn immediately after the completion test battery. Blood plasma level of monoamine oxidase (MAOs) activity will be determined using the Amplex Red Monoamine Oxidase Assay Kit to assess the inhibitory effects of muscadine wine/juice on MAOs.
Baseline, acute (4-hour post single dose), chronic (end of six week)
Change from baseline neurotransmitters
Time Frame: Baseline, acute (4-hour post single dose), chronic (end of six week)
Plasma levels of acetylcholine, dopamine, melatonin, serotonin, epinephrine, and γ-aminobutyric acid (GABA) will be quantified using the targeted metabolomic method on UHPLC-MS/MS
Baseline, acute (4-hour post single dose), chronic (end of six week)
Change from baseline brain-derived neurotrophic factors
Time Frame: Baseline, acute (4-hour post single dose), chronic (end of six week)
plasma BDNF will be measured using ELISA
Baseline, acute (4-hour post single dose), chronic (end of six week)
Change from baseline cortisol, TNF-α, high sensitivity C-reactive protein, and LPS binding protein
Time Frame: Baseline, acute (4-hour post single dose), chronic (end of six week)
Plasma levels will be measured using ELISA
Baseline, acute (4-hour post single dose), chronic (end of six week)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline mood and anxiety score after intervention/placebo
Time Frame: Baseline, acute (4-hour post single dose), chronic (end of six week)

Participants will complete the NIH Toolbox emotion battery. The test battery include two self-report measure,

  1. Positive affect survey (assess mood): 5-point scale with options ranging from "not at all" to "very much." higher scores are indicative of more positive affect
  2. Fear-Affect Survey (assess anxiety): 5-point scale with options ranging from "never" to "always." higher scores are indicative of more feelings of fear and anxiety
Baseline, acute (4-hour post single dose), chronic (end of six week)
Change from baseline depression score after intervention/placebo
Time Frame: Baseline, acute (4-hour post single dose), chronic (end of six week)
Depression score will be assessed with Beck's Depression inventory. The questionnaire consists of 21 items with a four point scale ranges between 0-3. The higher the total score the more severe the depression.
Baseline, acute (4-hour post single dose), chronic (end of six week)
Change from baseline pro-inflammatory cytokines
Time Frame: Baseline, acute (4-hour post single dose), chronic (end of six week)
Inflammatory response will be evaluated by measuring the plasma level of pro-inflammatory cytokines IL-1beta, IL-6, and TNF-alpha using Elisa Kits
Baseline, acute (4-hour post single dose), chronic (end of six week)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Investigators

  • Principal Investigator: Liwei Gu, PhD, University of Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

September 12, 2022

First Submitted That Met QC Criteria

September 12, 2022

First Posted (Actual)

September 15, 2022

Study Record Updates

Last Update Posted (Actual)

June 12, 2025

Last Update Submitted That Met QC Criteria

June 9, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB202300014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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