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

NCT05541887 | Recruiting

• 1 other identifier: IRB202300014
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Cognitive Performance; Memory; Mood; Anxiety

Outcome Measures

Primary Outcomes (7)

• 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.

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

• 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

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

• 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

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

• 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.

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

• Change from baseline neurotransmitters

  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

  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

  Plasma levels will be measured using ELISA

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

Secondary Outcomes (3)

• Change from baseline mood and anxiety score after intervention/placebo

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

• Change from baseline depression score after intervention/placebo

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

• Change from baseline pro-inflammatory cytokines

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

Study Arms (2)

Intervention-Placebo

ACTIVE COMPARATOR

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; Other: Placebo

Placebo-Intervention

ACTIVE COMPARATOR

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; Other: Placebo

Interventions

Muscadine Wine Polyphenol OTHER

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

Also known as: Dealcoholized Muscadine Wine

Intervention-Placebo; Placebo-Intervention

Placebo OTHER

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

Intervention-Placebo; Placebo-Intervention

Eligibility Criteria

• Age: 50 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy
• BMI (18.5-29.9)
• Body weight ≥110 pounds

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

Food Science and human nutrition department at University of Florida

Gainesville, Florida, 32611, United States

RECRUITING

Related Publications (10)

• Menard C, Pfau ML, Hodes GE, Kana V, Wang VX, Bouchard S, Takahashi A, Flanigan ME, Aleyasin H, LeClair KB, Janssen WG, Labonte B, Parise EM, Lorsch ZS, Golden SA, Heshmati M, Tamminga C, Turecki G, Campbell M, Fayad ZA, Tang CY, Merad M, Russo SJ. Social stress induces neurovascular pathology promoting depression. Nat Neurosci. 2017 Dec;20(12):1752-1760. doi: 10.1038/s41593-017-0010-3. Epub 2017 Nov 13.

  PMID: 29184215 BACKGROUND

• Du X, Pang TY. Is Dysregulation of the HPA-Axis a Core Pathophysiology Mediating Co-Morbid Depression in Neurodegenerative Diseases? Front Psychiatry. 2015 Mar 9;6:32. doi: 10.3389/fpsyt.2015.00032. eCollection 2015.

  PMID: 25806005 BACKGROUND

• Haskell-Ramsay CF, Stuart RC, Okello EJ, Watson AW. Cognitive and mood improvements following acute supplementation with purple grape juice in healthy young adults. Eur J Nutr. 2017 Dec;56(8):2621-2631. doi: 10.1007/s00394-017-1454-7. Epub 2017 Apr 20.

  PMID: 28429081 BACKGROUND

• Lamport DJ, Lawton CL, Merat N, Jamson H, Myrissa K, Hofman D, Chadwick HK, Quadt F, Wightman JD, Dye L. Concord grape juice, cognitive function, and driving performance: a 12-wk, placebo-controlled, randomized crossover trial in mothers of preteen children. Am J Clin Nutr. 2016 Mar;103(3):775-83. doi: 10.3945/ajcn.115.114553. Epub 2016 Feb 10.

  PMID: 26864371 BACKGROUND

• Whyte AR, Schafer G, Williams CM. Cognitive effects following acute wild blueberry supplementation in 7- to 10-year-old children. Eur J Nutr. 2016 Sep;55(6):2151-62. doi: 10.1007/s00394-015-1029-4. Epub 2015 Oct 5.

  PMID: 26437830 BACKGROUND

• Watson AW, Haskell-Ramsay CF, Kennedy DO, Cooney JM, Trower T, Scheepens A. Acute supplementation with blackcurrant extracts modulates cognitive functioning and inhibits monoamine oxidase-B in healthy young adults. Journal of Functional Food. 2015 Aug;17:524-539. doi:10.1016/j.jff.2015.06.005

  BACKGROUND

• Kennedy DO, Bonnlander B, Lang SC, Pischel I, Forster J, Khan J, Jackson PA, Wightman EL. Acute and Chronic Effects of Green Oat (Avena sativa) Extract on Cognitive Function and Mood during a Laboratory Stressor in Healthy Adults: A Randomised, Double-Blind, Placebo-Controlled Study in Healthy Humans. Nutrients. 2020 May 29;12(6):1598. doi: 10.3390/nu12061598.

  PMID: 32485993 BACKGROUND

• Bandaruk Y, Mukai R, Kawamura T, Nemoto H, Terao J. Evaluation of the inhibitory effects of quercetin-related flavonoids and tea catechins on the monoamine oxidase-A reaction in mouse brain mitochondria. J Agric Food Chem. 2012 Oct 17;60(41):10270-7. doi: 10.1021/jf303055b. Epub 2012 Oct 8.

  PMID: 23009399 BACKGROUND

• Zhu WL, Shi HS, Wei YM, Wang SJ, Sun CY, Ding ZB, Lu L. Green tea polyphenols produce antidepressant-like effects in adult mice. Pharmacol Res. 2012 Jan;65(1):74-80. doi: 10.1016/j.phrs.2011.09.007. Epub 2011 Sep 22.

  PMID: 21964320 BACKGROUND

• Olasehinde TA, Oyeleye SI, Ibeji CU, Oboh G. Beetroot supplemented diet exhibit anti-amnesic effect via modulation of cholinesterases, purinergic enzymes, monoamine oxidase and attenuation of redox imbalance in the brain of scopolamine treated male rats. Nutr Neurosci. 2022 May;25(5):1011-1025. doi: 10.1080/1028415X.2020.1831260. Epub 2020 Oct 15.

  PMID: 33054666 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Liwei Gu, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kylee Mai

CONTACT

479-203-8170; cmai1@ufl.edu

Liwei Gu, PhD

CONTACT

Lgu@ufl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: September 15, 2022
• Study Start: August 30, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)