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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-65
SponsorUniversity of Florida

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy

BMI (18.5-29.9)

Body weight ≥110 pounds

Disqualifiers

Pregnancy

Breast-feeding

Smokers

Diabetic

Trial design

Design model

Crossover

Treatments tested in this trial

  • Muscadine Wine Polyphenol

    Other intervention

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

  • Placebo

    Other intervention

    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

Treatment groups

25 Participants
are divided into 2 treatment groups
Group A: Intervention-PlaceboActive comparator 2 interventions
Group B: Placebo-InterventionActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Change from baseline cognitive performance score after intervention/placebo

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.

Time frame
Baseline, acute (4-hour post single dose), chronic (end of six week)
2

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

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

Time frame
Baseline, acute (4-hour post single dose), chronic (end of six week)
3

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

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

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

Change from baseline monoamine oxidase (MAOs) activity

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.

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

Secondary outcomes

1

Change from baseline mood and anxiety score after intervention/placebo

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

Time frame
Baseline, acute (4-hour post single dose), chronic (end of six week)
2

Change from baseline depression score after intervention/placebo

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.

Time frame
Baseline, acute (4-hour post single dose), chronic (end of six week)
3

Change from baseline pro-inflammatory cytokines

Inflammatory response will be evaluated by measuring the plasma level of pro-inflammatory cytokines IL-1beta, IL-6, and TNF-alpha using Elisa Kits

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.