Muscadine Wine Polyphenols for Cognitive Functioning

Overseen By Kylee Mai

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Must not be taking: Psychostimulants, cannabis products

Disqualifiers: Pregnancy, Diabetes, Mental illnesses, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether muscadine wine polyphenols, compounds found in certain fruits and foods, can enhance memory, mood, and overall brain function. Researchers aim to determine if these polyphenols help by reducing stress and inflammation or improving brain chemical balance. Participants will either begin with a placebo and then switch to the polyphenols or vice versa, each for six weeks with a break in between. This trial suits healthy individuals who weigh at least 110 pounds and have no significant mental health issues. As an unphased study, it offers a unique opportunity to contribute to groundbreaking research on natural compounds and their potential brain health benefits.

Will I have to stop taking my current medications?

The trial requires that you stop taking any medication that might influence the study's outcome, such as psychostimulants. If you're on such medications, you may need to stop them to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that muscadine wine polyphenols offer potential health benefits, particularly as antioxidants. They might help protect cells from damage. Some studies in mice suggest these polyphenols could aid with memory issues like Alzheimer's. However, these studies have not been conducted in humans and remain in the early stages of understanding the full effects.

For humans, muscadine wine polyphenols are generally considered safe because they come from grapes, which are commonly consumed. The trial tests a nutraceutical, a product made from food with added health benefits. While specific safety data for humans isn't detailed, the trial's existence suggests it is considered safe enough for further testing. If this treatment posed significant danger, it wouldn't have reached this research stage. Always consult a healthcare provider before joining a clinical trial to discuss any concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about muscadine wine nutraceuticals for cognitive functioning because they offer a novel approach by harnessing the power of polyphenols. Polyphenols are natural compounds found in plants known for their antioxidant properties, which could help protect brain cells from damage. Unlike standard treatments for cognitive decline, which often involve pharmaceuticals targeting specific neurotransmitters, muscadine wine polyphenols may provide a more holistic, natural method by reducing oxidative stress and inflammation in the brain. This treatment's potential to improve cognitive health in a natural way has researchers eager to explore its full benefits.

What evidence suggests that muscadine wine polyphenols might be an effective treatment for cognitive functioning?

Research shows that polyphenols, natural compounds in foods and drinks like muscadine wine, may enhance brain functions, memory, and mood. Studies suggest these polyphenols might protect against memory loss and dementia by reducing inflammation and damage from harmful molecules in the brain. Evidence indicates that polyphenols can help manage the body's stress response, potentially improving mood and reducing depression and anxiety. While research on muscadine wine polyphenols continues, similar compounds in red wine have shown promise in early studies. This trial will evaluate the effects of muscadine wine polyphenols on cognitive functioning, with participants receiving either muscadine wine polyphenols or a placebo in different phases. Overall, these findings suggest that muscadine wine could benefit brain health and mood. ^{1 2 6 7 8}

Who Is on the Research Team?

Liwei Gu, PhD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My weight is at least 110 pounds.

Healthy

BMI between 18.5 and 29.9

Exclusion Criteria

I am not taking any medication that could affect the study results.

I have diabetes.

I have a history of heart or brain disorders.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase 1

Participants consume either placebo or muscadine wine polyphenol for six weeks

6 weeks

Washout

A 21-day washout period between treatment phases

3 weeks

Treatment Phase 2

Participants switch treatments and consume either muscadine wine polyphenol or placebo for another six weeks

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Muscadine Juice
• Muscadine Wine Nutraceuticals
• Muscadine Wine Polypehnol
• Placebo
• Sprite
• Vodka

Trial Overview 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.

How Is the Trial Designed?

Group I: Placebo-Intervention Active Control 2 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-Placebo Active Control 2 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

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Published Research Related to This Trial

Four types of Spanish red wines (Merlot, Tempranillo, Garnacha, and Cabernet-Sauvignon) were studied for their neuroprotective effects, with Merlot showing the highest activity due to its rich polyphenolic content.

The neuroprotection observed in these wines is linked to their ability to scavenge free radicals and protect astrocytes from oxidative stress, suggesting that the polyphenols in red wine contribute to its antioxidant properties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study of red wine neuroprotection on astrocytes. Gómez-Serranillos, MP., Martín, S., Ortega, T., et al.[2021]

In a study involving rats, specific polyphenolic metabolites from Cabernet Sauvignon red wine were found to accumulate in the brain, with quercetin-3-O-glucuronide significantly reducing the generation of harmful beta-amyloid peptides associated with Alzheimer's disease.

Quercetin-3-O-glucuronide not only interfered with the formation of neurotoxic beta-amyloid aggregates but also improved synaptic transmission and long-term potentiation in the hippocampus, suggesting it may have multiple beneficial effects on Alzheimer's disease mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of brain-targeted bioactive dietary quercetin-3-O-glucuronide as a novel intervention for Alzheimer's disease. Ho, L., Ferruzzi, MG., Janle, EM., et al.[2021]

Polyphenols, particularly those found in grapes and berries, have been shown to help delay age-related cognitive decline and neurodegenerative diseases due to their antioxidant and anti-inflammatory properties.

Combining polyphenol consumption with regular physical exercise may enhance cognitive benefits for the aging brain, suggesting a potential for developing neuro-nutraceuticals as functional foods to support brain health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Polyphenols as an Effective Therapeutic Intervention Against Cognitive Decline During Normal and Pathological Brain Aging. Devi, SA., Chamoli, A.[2020]

Combining three polyphenolic compounds (grape seed extract, resveratrol, and Concord grape juice extract) showed enhanced protection against cognitive impairments in a mouse model of Alzheimer's disease compared to individual treatments.

The combination treatment significantly reduced total amyloid content in the brain and improved long-term potentiation deficits, suggesting that targeting multiple disease mechanisms with polyphenols may increase therapeutic efficacy for Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting multiple pathogenic mechanisms with polyphenols for the treatment of Alzheimer's disease-experimental approach and therapeutic implications. Wang, J., Bi, W., Cheng, A., et al.[2021]

Moderate consumption of two different red wines, Cabernet Sauvignon and muscadine, showed promise in reducing Alzheimer's disease symptoms in a transgenic mouse model, indicating potential benefits of polyphenolic compounds in these wines.

Cabernet Sauvignon was found to lower the production of amyloid-beta peptides, while muscadine interfered with the harmful aggregation of these peptides, suggesting that different wines may work through unique mechanisms to combat Alzheimer's pathology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heterogeneity in red wine polyphenolic contents differentially influences Alzheimer's disease-type neuropathology and cognitive deterioration. Ho, L., Chen, LH., Wang, J., et al.[2021]

Regular moderate wine consumption may reduce the risk of chronic diseases linked to inflammation, but the health benefits depend on the type of wine and its polyphenol content.

The review highlights that both alcohol and polyphenols in wine could contribute to health benefits, with the overall effect influenced by individual dietary patterns and the specific mechanisms related to cardiovascular disease development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wine and health: state of proofs and research needs. Walzem, RL.[2011]

Moderate wine consumption, particularly red wine, may help prevent chronic diseases due to its high levels of antioxidants like resveratrol, anthocyanins, and catechins.

Resveratrol specifically contributes to cardiovascular health by neutralizing harmful free radicals, protecting brain cells, and reducing blood clot formation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contribution of Red Wine Consumption to Human Health Protection. Snopek, L., Mlcek, J., Sochorova, L., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05541887

Study Details | NCT05541887 | Use Muscadine Wine ... We hypothesize that intake of muscadine wine polyphenols enhances cognition and memory and improve depression and anxiety in healthy adults over 50 year-old ...

2. trialx.com trialx.com/clinical-trials/listings/269727/use-muscadine-wine-nutraceuticals-to-improve-brain-health-cognition-and-mental-health/

Use Muscadine Wine Nutraceuticals to Improve Brain ... We hypothesize that intake of muscadine wine polyphenols enhances cognition and memory and improve depression and anxiety in healthy adults over 50 year-old.

3. blogs.ifas.ufl.edu blogs.ifas.ufl.edu/fshndept/?p=4631

Muscadine Wine Polyphenols | Effects on Cognition and Mood If these effects exist, incorporating muscadine wine polyphenols into our diets may help prevent the development of cognitive decline or mental ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11510231/

The Potential Effects of Red Wine and Its Components on ... The main findings highlight a protective effect of wine polyphenols present in red wine on dementia in different preclinical models of cognitive decline.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9686579/

Targeted UHPLC-MS Analysis Reveals Disparate ... Heterogeneity in red wine polyphenolic contents differentially influences Alzheimer's disease-type neuropathology and cognitive deterioration.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2857553/

Heterogeneity in Red Wine Polyphenolic Contents ... Muscadine treatment attenuates AD-type cognitive deterioration in Tg2576 mice. In this study, we explored the potential impact of muscadine treatment on ...

7. mdpi.com mdpi.com/2072-6643/17/14/2327

Effect of Dealcoholized Muscadine Wine on the ... Purple muscadine wine polyphenols have a unique composition and possible disease-preventive properties. This study aims to determine how dealcoholized muscadine ...

8. smallfruits.cals.ncsu.edu smallfruits.cals.ncsu.edu/2020/06/critical-article-muscadines-health-benefits/

Critical Article: Muscadine's Health Benefits - Small Fruits Muscadines have been evaluated for their benefits on human health for several decades, especially due to their high antioxidant capacity and abundant phenolic ...