SuspendedNot Applicable

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

Stopped: Funding for this study was discontinued by the sponsor after the first year.

United States25 participantsStarted 2023-08-30

Plain-language 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

Who can participate

Age range

50 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from baseline cognitive performance score after intervention/placebo

Timeframe: Baseline, acute (4-hour post single dose), chronic (end of six week)

Change from baseline cognitive performance score after intervention/placebo - continued

Timeframe: Baseline, acute (4-hour post single dose), chronic (end of six week)

Change from baseline cognitive performance score after intervention/placebo - continued

Timeframe: Baseline, acute (4-hour post single dose), chronic (end of six week)

Change from baseline monoamine oxidase (MAOs) activity

Timeframe: Baseline, acute (4-hour post single dose), chronic (end of six week)

Change from baseline neurotransmitters

Timeframe: Baseline, acute (4-hour post single dose), chronic (end of six week)

Change from baseline brain-derived neurotrophic factors

Timeframe: Baseline, acute (4-hour post single dose), chronic (end of six week)

Trial details

NCT IDNCT05541887

SponsorUniversity of Florida

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12-31

View on ClinicalTrials.gov More Cognitive Performance trials

Plain-language summary

Who can participate

Age range

50 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change from baseline cognitive performance score after intervention/placebo

Timeframe: Baseline, acute (4-hour post single dose), chronic (end of six week)

Change from baseline cognitive performance score after intervention/placebo - continued

Timeframe: Baseline, acute (4-hour post single dose), chronic (end of six week)

Change from baseline cognitive performance score after intervention/placebo - continued

Timeframe: Baseline, acute (4-hour post single dose), chronic (end of six week)

Change from baseline monoamine oxidase (MAOs) activity

Timeframe: Baseline, acute (4-hour post single dose), chronic (end of six week)

Change from baseline neurotransmitters

Timeframe: Baseline, acute (4-hour post single dose), chronic (end of six week)

Change from baseline brain-derived neurotrophic factors

Timeframe: Baseline, acute (4-hour post single dose), chronic (end of six week)