Chardonnay Marc for Gut and Heart Health

Overseen By Roberta R Holt, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of California, Davis

Must not be taking: Anticoagulants, NSAIDs, Supplements

Disqualifiers: Vegan, Heart disease, Cancer, others

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

Compensation: Varies

Number of Visits: 3

5 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how adding Chardonnay Marc (grape skins and seeds) to the diet might improve gut and heart health. Researchers are examining how this source of dietary flavanols could affect specific health markers. Participants will consume either a small or larger daily amount of Chardonnay Marc powder. Women who are postmenopausal (no periods for over two years), have a BMI of 25-49.9, and have fasting triglycerides over 120 mg/dL may be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on dietary interventions for health improvement.

Will I have to stop taking my current medications?

The trial requires participants to stop taking any supplements, including herbal, plant, botanical, fish oil, and oil supplements, six weeks before joining. However, if you are on a stable dose of thyroid medication for at least six months, you can continue taking it. Other prescription medications are not allowed.

What prior data suggests that Chardonnay Marc is safe for gut and heart health?

Research has shown that Chardonnay Marc, derived from the skins and seeds of Chardonnay grapes, is rich in flavanols. These natural compounds, also found in foods like tea and berries, may support heart and gut health. Although specific safety data on Chardonnay Marc in humans is lacking, similar foods have been consumed safely. Wine, made from grapes, is enjoyed globally.

This trial is in the "Not Applicable" phase, indicating that Chardonnay Marc is being tested for general safety and effects. This phase usually suggests that the treatment is expected to be safe based on knowledge of similar ingredients. Participants in this study will try two different amounts: 1.5 grams and 4.5 grams per day, comparable to typical dietary supplements.

While specific safety data for Chardonnay Marc is not yet available, its components are common in other foods and have been used safely before. It is important to consult a healthcare provider before trying something new to ensure it is appropriate. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Chardonnay Marc for gut and heart health because it introduces a natural, plant-based approach unlike typical medications. Derived from the byproducts of Chardonnay grape production, this treatment taps into the polyphenols and fiber found in grape marc, which are believed to support gut microbiota and cardiovascular function. Unlike standard treatments that often focus on pharmaceuticals, Chardonnay Marc offers a potentially safer and more holistic alternative, with two different dosage levels being explored for optimal health benefits.

What evidence suggests that Chardonnay Marc could be effective for gut and heart health?

Studies have shown that Chardonnay Marc, made from the skins and seeds of Chardonnay grapes, is rich in flavanols. These natural compounds have been linked to better heart health and may reduce the risk of heart disease. Research also indicates that Chardonnay Marc provides fiber and other substances beneficial for gut health. In this trial, participants will receive different intake levels of Chardonnay Marc to evaluate its effects. Previous participants experienced positive effects on heart health when they included Chardonnay Marc in their diet. This suggests that adding Chardonnay Marc could improve both heart and gut health. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with conditions like obesity, metabolic syndrome, or at risk of heart disease. Participants should be interested in testing whether adding Chardonnay Marc (grape skins and seeds) to their diet can improve gut and heart health.

Inclusion Criteria

BMI 31-49.9 kg/m2

Fasting triglycerides > 120 mg/dL

I am a postmenopausal woman who has not had a period for at least 2 years.

Exclusion Criteria

I take daily medication to thin my blood, including aspirin or NSAIDs.

Vegan, Vegetarians, food faddists or those consuming a non-traditional diet

Fruit consumption ≥ 3 cups/day

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Level 1

Participants incorporate 1.5 g of Chardonnay Marc into their diet daily for the first 6 weeks

6 weeks

1 visit (in-person) at baseline

Treatment Level 2

Participants increase intake to 4.5 g of Chardonnay Marc daily from weeks 6 to 12

6 weeks

1 visit (in-person) after 6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person) after 12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Chardonnay Marc

Trial Overview The study tests the effects of daily Chardonnay Marc powder on gut and cardiometabolic health. It aims to gather initial data on how this flavanol-rich food influences markers related to these areas.

How Is the Trial Designed?

Group I: Chardonnay Marc Intake Level 2 Experimental Treatment 1 Intervention

Daily intake of Chardonnay marc at 4.5 g

Group II: Chardonnay Marc Intake Level 1 Experimental Treatment 1 Intervention

Daily intake of Chardonnay marc at 1.5 g

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Published Research Related to This Trial

Light to moderate alcohol intake may protect against coronary heart disease (CHD), especially in middle-aged and elderly adults, but this benefit is not seen in young adults.

The cardioprotective effects of alcohol vary by gender, with women experiencing lower thresholds for risk compared to men, and steady drinking patterns being more beneficial than binge drinking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alcohol and atherosclerosis: recent insights. Tolstrup, J., Grønbaek, M.[2019]

L-valine produced by the non-genetically modified strain Corynebacterium glutamicum (CGMCC 18932) is deemed safe for all animal species when used as a nutritional additive, with no safety concerns for consumers or the environment.

The study concluded that while l-valine is effective for non-ruminant animals, it requires protection to maintain efficacy in ruminants due to potential degradation in the rumen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a feed additive consisting of l-valine produced by Corynebacterium glutamicum CGMCC 18932 for all animal species (Xinjiang Fufeng Biotechnologies Co., Ltd.). Bampidis, V., Azimonti, G., Bastos, ML., et al.[2023]

Moderate alcohol consumption, particularly around two drinks per day, is associated with a lower risk of ischemic heart disease, while higher consumption increases the risk of heart issues.

Red wine offers unique cardioprotective benefits due to its higher flavonoid content, such as resveratrol and quercetin, which have strong antioxidant properties compared to other alcoholic beverages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alcohol, ischemic heart disease, and the French paradox. Constant, J.[2019]

Moderate consumption of red wine is associated with cardiovascular health benefits, likely due to its alcohol content and antioxidant properties that help reduce oxidative stress.

Red wine may improve cardiac function by protecting endothelial function and activating mechanisms that support heart health, such as adenosine receptors and nitric oxide synthase.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experimental evidence for the cardioprotective effects of red wine. Das, S., Santani, DD., Dhalla, NS.[2021]

Grape pomace, a by-product of wine production, is a valuable source of polyphenols and dietary fibers, which can be used to create plant food supplements with antioxidant properties.

However, there are potential risks associated with these products, including contamination with harmful compounds like the mycotoxin ochratoxin A, highlighting the need for stricter regulations in Europe to ensure safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plant Food Supplements with Antioxidant Properties for the Treatment of Chronic and Neurodegenerative Diseases: Benefits or Risks? Piemontese, L.[2017]

Young weanling mice exposed to ochratoxin A developed significant liver and kidney damage, including the formation of tumors, with 25% showing renal carcinoma.

The concurrent administration of grape berry and leaf juice significantly protected the mice from these harmful effects, preventing the development of hepatorenal carcinoma altogether.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antidotal effect of grape juice (Vitis vinifera) on ochratoxin A caused hepatorenal carcinogenesis in mice (Mus musculus). Jeswal, P.[2013]

In a study analyzing 64 samples of grape juice and frozen grape pulps, 25% tested positive for Ochratoxin A (OA), with an average concentration of 37 ng/l, indicating a notable presence of this harmful toxin in these products.

Among 80 wine samples tested, 28.75% were positive for OA, with red wines showing the highest contamination levels, but the detected concentrations were below the established safe daily intake limit for humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occurrence of ochratoxin A in wine and grape juice marketed in Rio de Janeiro, Brazil. Rosa, CA., Magnoli, CE., Fraga, ME., et al.[2012]

Steam extraction during juice production significantly reduces ochratoxin A (OTA) levels, with a 73% reduction compared to 66% and 44% reductions during red and white winemaking, respectively.

Despite the reduction, the estimated OTA exposure from juice consumption exceeds the tolerable intake levels, primarily due to higher OTA levels in Concord grapes and greater daily juice consumption compared to wine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exposure risk assessment to ochratoxin A through consumption of juice and wine considering the effect of steam extraction time and vinification stages. Dachery, B., Veras, FF., Dal Magro, L., et al.[2018]

Moderate alcohol consumption may be linked to lower all-cause mortality and reduced cardiovascular disease risk, primarily by increasing beneficial high-density lipoprotein cholesterol and improving endothelial function, but this relationship is not definitively proven due to a lack of randomized controlled trials.

Despite some observational data suggesting benefits, alcohol should not be recommended as a method to reduce cardiovascular risk, as it poses significant risks including habituation and abuse, and well-established alternatives like diet and exercise are more effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alcohol, heart disease, and mortality: a review. Vogel, RA.[2007]

Moderate wine consumption (up to 300 ml per day) is associated with a reduced risk of cardiovascular events, based on a meta-analysis of 19 studies.

The potential cardioprotective effects of wine may be due to both ethanol's ability to raise HDL cholesterol and the beneficial properties of wine's polyphenolic components, which include antioxidant and antithrombotic effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The relationship between wine consumption and cardiovascular risk: from epidemiological evidence to biological plausibility. Rotondo, S., Di Castelnuovo, A., de Gaetano, G.[2011]

Moderate alcohol consumption, particularly the equivalent of two drinks per day, is associated with a lower risk of ischemic heart disease, while higher consumption increases the risk of heart issues.

Red wine offers unique cardioprotective benefits due to its flavonoid content, such as resveratrol and quercetin, which have stronger antioxidant properties compared to those found in white wine and beer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alcohol, ischemic heart disease, and the French paradox. Constant, J.[2023]

Moderate alcohol consumption, particularly in the form of wine, has been linked to a reduced risk of coronary artery disease (CHD), primarily through mechanisms such as increased HDL cholesterol and improved blood platelet function.

Wine may offer additional cardiovascular benefits beyond alcohol content due to its polyphenolic compounds, which have anti-inflammatory, antioxidant, and vaso-relaxant properties, suggesting that wine could be more protective than other alcoholic beverages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The mediterranean lecture: wine and thrombosis--from epidemiology to physiology and back. de Gaetano, G., Di Castelnuovo, A., Donati, MB., et al.[2017]

Citations

1. pubs.acs.org pubs.acs.org/doi/10.1021/acs.jafc.2c04519

Chardonnay Marc as a New Model for Upcycled Co-products ... The complex mixture of PBNPs within marc, grape fruit, juice and powder has shown positive effects on cardiovascular outcomes in a number of dietary ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9732887/

Chardonnay Marc as a New Model for Upcycled Co-products ... This review explores the potential of Chardonnay marc as a valuable new PBNP ingredient in the food system by combining health, sensory, and environmental ...

3. trialx.com trialx.com/clinical-trials/listings/319454/the-influence-of-chardonnay-marc-intake-on-gut-and-cardiometabolic-health/

The Influence of Chardonnay Marc Intake on Gut and ... Like other flavanol-rich foods, Chardonnay Marc provides fiber and polysaccharides that may benefit gut health. This study seeks pilot data on ...

4. caes.ucdavis.edu caes.ucdavis.edu/news/chardonnay-marc-trifecta-health-taste-and-sustainability

Chardonnay Marc: A 'Trifecta' of Health, Taste and Sustainability The paper illustrates that grape marc contains high levels of flavanols, which have been shown to have positive effects on the cardiovascular ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0023643821003455

A second life for wine grapes Chardonnay marc (pomace), an agricultural waste product, has demonstrated significant potential health benefits in previous studies.

6. withpower.com withpower.com/trial/phase-cardiometabolic-syndrome-5-2024-37267

Chardonnay Marc for Gut and Heart Health Is Chardonnay Marc safe for human consumption? There is no specific safety data available for Chardonnay Marc or its related names in humans. However, wine ...

7. wellvine.com wellvine.com/?srsltid=AfmBOoqeDsjXETqWFL1sCDY6xJbXqSeoWUs91u_QbHdBOcA4EPvE5aIm

WellVine: Real Food Prebiotic with Chardonnay Marc | Gut ... WellVine is a prebiotic from Chardonnay grapes, made from leftover grapes, that contains oligosaccharides, polyphenols, flavanols, and catechins.