Cognitive PerformanceNCT05541887
Use Muscadine Wine Nutraceuticals to Improve Brain Health, Cognition, and Mental Health
A study testing Muscadine Wine Polyphenol in people with Cognitive Performance and Memory, run by University of Florida at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Performance, Memory, Mood
- What is being tested?
- Muscadine Wine Polyphenol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2023to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy
- BMI (18.5-29.9)
- Body weight ≥110 pounds
Who cannot join
- Pregnancy
- Breast-feeding
- Smokers
- Diabetic
- Heavy drinkers
- Subjective but not clinically diagnosed cognitive impairment (Montreal cognitive assessment score <26),
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Food Science and human nutrition department at University of Florida
Gainesville, Florida, 32611
About this study
Official title: Acute and Chronic Impacts of Muscadine Wine Polyphenols on Cognition, Memory, Mood, and Anxiety in Adults Over 50 Years of Age
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
Read the detailed description
Although the exact biological mechanisms for depression and Alzheimer's Disease are not fully understood, it's believed that they are caused by a combination of factors. An increasing amount of scientific research has proposed several possible pathophysiologies linking depression and AD. For example, increased production of pro-inflammatory cytokines in the nervous system, oxidative stress induced by chronic inflammation leads to dysregulation of the hypothalamic-pituitary-adrenal (HPA) axis, and disturbance in the brain-derived neurotrophic factor signal pathway. Polyphenol has been well recognized for its antioxidant and anti-inflammatory properties. Previous studies have shown that polyphenol-rich food such as concord grape juice, blueberries, blackcurrants, and green oats positively affect cognition, memory, and mood in humans. However, no one has examined the effects of muscadine wine polyphenol on cognitive and mental health. In addition, if they do have effects, through what mechanism? This clinical trial will allow us to investigate the questions raised. We hypothesize that intake of muscadine wine polyphenols enhances cognition and memory and improve depression and anxiety in healthy adults over 50 year-old via regulating the HPA axis, alleviating inflammation and oxidative stress, and/or inhibiting monoamine oxidase activities. The research will provide the first clinical evidence of how muscadine wine polyphenols affect the brain and mental health.
- Conditions
- Cognitive Performance, Memory, Mood, Anxiety
- Being tested
- Muscadine Wine Polyphenol, Placebo
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscadine Wine PolyphenolOther
Also called Dealcoholized Muscadine Wine
dealcoholized muscadine wine with alcohol content <0.5% with addition of 50ppm of sodium metabisulfite for preservation
PlaceboOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Muscadine Wine Polyphenol; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, acute (4-hour post single dose), chronic (end of six week)
Change from baseline cognitive performance score after intervention/placebo - continued
- 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
Measured: Baseline, acute (4-hour post single dose), chronic (end of six week)
Change from baseline cognitive performance score after intervention/placebo - continued
- 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Participants will complete the NIH Toolbox emotion battery. The test battery include two self-report measure,
- 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
- 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
Measured: Baseline, acute (4-hour post single dose), chronic (end of six week)
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.
Measured: Baseline, acute (4-hour post single dose), chronic (end of six week)
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
Measured: Baseline, acute (4-hour post single dose), chronic (end of six week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start30 Aug 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Why it stopped: Funding for this study was discontinued by the sponsor after the first year.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Cognitive PerformanceStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liwei Gu, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05541887
- Sponsor's protocol ID
- IRB202300014
- Status last verified
- Aug 2026
- First submitted
- 12 Sep 2022
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29184215Du 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.
PubMed 25806005Haskell-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.
PubMed 28429081Lamport 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.
PubMed 26864371Whyte 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.
PubMed 26437830Watson 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
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.
PubMed 32485993Bandaruk 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.
PubMed 23009399Zhu 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.
PubMed 21964320Olasehinde 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.
PubMed 33054666
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute and Chronic Impacts of Muscadine Wine Polyphenols on Cognition, Memory, Mood, and Anxiety in Adults Over 50 Years of Age
- ClinicalTrials.gov ID
- NCT05541887
- Acronym / sponsor ID
- IRB202300014
- Conditions
- Cognitive Performance, Memory, Mood, Anxiety
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Funding for this study was discontinued by the sponsor after the first year.
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 15 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Although the exact biological mechanisms for depression and Alzheimer's Disease are not fully understood, it's believed that they are caused by a combination of factors. An increasing amount of scientific research has proposed several possible pathophysiologies linking depression and AD. For example, increased production of pro-inflammatory cytokines in the nervous system, oxidative stress induced by chronic inflammation leads to dysregulation of the hypothalamic-pituitary-adrenal (HPA) axis, and disturbance in the brain-derived neurotrophic factor signal pathway. Polyphenol has been well recognized for its antioxidant and anti-inflammatory properties. Previous studies have shown that polyphenol-rich food such as concord grape juice, blueberries, blackcurrants, and green oats positively affect cognition, memory, and mood in humans. However, no one has examined the effects of muscadine wine polyphenol on cognitive and mental health. In addition, if they do have effects, through what mechanism? This clinical trial will allow us to investigate the questions raised. We hypothesize that intake of muscadine wine polyphenols enhances cognition and memory and improve depression and anxiety in healthy adults over 50 year-old via regulating the HPA axis, alleviating inflammation and oxidative stress, and/or inhibiting monoamine oxidase activities. The research will provide the first clinical evidence of how muscadine wine polyphenols affect the brain and mental health.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention-Placebo | Active comparator | Other: Muscadine Wine Polyphenol, Other: PlaceboParticipants 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 |
| Placebo-Intervention | Active comparator | Other: Muscadine Wine Polyphenol, Other: PlaceboParticipants 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 |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy
- BMI (18.5-29.9)
- Body weight ≥110 pounds
Key exclusion criteria (12 listed)
- Pregnancy
- Breast-feeding
- Smokers
- Diabetic
- Heavy drinkers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Muscadine Wine PolyphenolAlso: Dealcoholized Muscadine Winedealcoholized muscadine wine with alcohol content <0.5% with addition of 50ppm of sodium metabisulfite for preservation | Other | Intervention-Placebo, Placebo-Intervention |
| Placebothis 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 | Other | Intervention-Placebo, Placebo-Intervention |
Primary outcome
Change from baseline cognitive performance score after intervention/placebo
Time frame: Baseline, 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 - continued
Time frame: Baseline, 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 - continued
Time frame: Baseline, 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) activity
Time frame: Baseline, 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 neurotransmitters
Time frame: Baseline, 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 factors
Time frame: Baseline, 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 protein
Time frame: Baseline, acute (4-hour post single dose), chronic (end of six week)
Plasma levels will be measured using ELISA
3 secondary outcomes
Change from baseline mood and anxiety score after intervention/placebo
Time frame: Baseline, acute (4-hour post single dose), chronic (end of six week)
Change from baseline depression score after intervention/placebo
Time frame: Baseline, acute (4-hour post single dose), chronic (end of six week)
Change from baseline pro-inflammatory cytokines
Time frame: Baseline, acute (4-hour post single dose), chronic (end of six week)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Background: PubMed 29184215Menard 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.
- Background: PubMed 25806005Du 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.
- Background: PubMed 28429081Haskell-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.
- Background: PubMed 26864371Lamport 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.
- Background: PubMed 26437830Whyte 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.
- BackgroundWatson 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: PubMed 32485993Kennedy 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.
- Background: PubMed 23009399Bandaruk 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.
- Background: PubMed 21964320Zhu 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.
- Background: PubMed 33054666Olasehinde 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liwei Gu, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Muscadine Wine Polyphenol in people with Cognitive Performance and Memory, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline cognitive performance score after intervention/placebo (time frame: Baseline, acute (4-hour post single dose), chronic (end of six week)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05541887, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.