Muscadine Wine Polyphenols for Cognitive Functioning

N/A

Recruiting

Led By Liwei Gu, PhD

Research Sponsored by University of Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, acute (4-hour post single dose), chronic (end of six week)

Summary

This trial will test if muscadine wine and juice can improve cognitive performance and mood by regulating the HPA axis, alleviating inflammation and oxidative stress, and/or inhibiting monoamine oxidase activities.

Who is the study for?

This trial is for healthy adults with a BMI of 18.5-29.9 and body weight over 110 pounds, who drink occasionally to moderately. It's not for smokers, heavy drinkers, pregnant or breastfeeding individuals, those with mental illnesses, cardiovascular or neurological disorders, diabetes, or on certain medications.

What is being tested?

The study tests if muscadine wine polyphenols can improve brain health and mood compared to a placebo. Participants will consume these compounds regularly to see if they affect cognitive performance by reducing stress responses and inflammation.

What are the potential side effects?

While the trial doesn't list specific side effects of muscadine wine polyphenols, similar substances sometimes cause digestive upset or allergic reactions in sensitive individuals.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, acute (4-hour post single dose), chronic (end of six week)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, acute (4-hour post single dose), chronic (end of six week)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, acute (4-hour post single dose), chronic (end of six week) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline brain-derived neurotrophic factors

Change from baseline cognitive performance score after intervention/placebo

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

+3 more

Secondary study objectives

Change from baseline depression score after intervention/placebo

Change from baseline mood and anxiety score after intervention/placebo

Change from baseline pro-inflammatory cytokines

Trial Design

2Treatment groups

Active Control

Group I: Placebo-InterventionActive Control2 Interventions

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 II: Intervention-PlaceboActive Control2 Interventions

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

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