Muscadine Wine Nutraceuticals for Brain Health, Cognition, and Mental Health
This study is looking into whether dealcoholized muscadine wine polyphenols can improve brain health, thinking skills (cognition), and mental well-being. Researchers believe that compounds in muscadine wine might help by reducing inflammation and stress in the body. You could be eligible if you are a healthy adult between 50 and 65 years old, have a healthy body weight (BMI 18.5-29.9 and weigh at least 110 pounds), and do not have certain health conditions like diabetes or cognitive impairment. The study will measure changes in your cognitive performance over time to see if the muscadine wine polyphenols have a positive effect. The current status of this study is unclear, and it plans to enroll 25 participants.
- Study design
- This is an interventional study, meaning participants will receive either the muscadine wine polyphenol or a matching placebo. The study plans to enroll 25 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your cognitive performance will be measured at the start, 4 hours after a single dose, and at the end of six weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Use Muscadine Wine Nutraceuticals to Improve Brain Health, Cognition, and Mental Health
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Liwei Gu, PhD · PRINCIPAL_INVESTIGATOR · University of Florida
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Change from baseline cognitive performance score after intervention/placeboBaseline, 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.
- Change from baseline cognitive performance score after intervention/placebo - continuedBaseline, 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
- Change from baseline cognitive performance score after intervention/placebo - continuedBaseline, 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
- Change from baseline monoamine oxidase (MAOs) activityBaseline, 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.
- Change from baseline neurotransmittersBaseline, 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
- Change from baseline brain-derived neurotrophic factorsBaseline, acute (4-hour post single dose), chronic (end of six week)
plasma BDNF will be measured using ELISA
- Change from baseline cortisol, TNF-α, high sensitivity C-reactive protein, and LPS binding proteinBaseline, acute (4-hour post single dose), chronic (end of six week)
Plasma levels will be measured using ELISA