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?

Recently a dietary recommendation of 400 - 600 mg/ day has been proposed for the reduced risk of developing cardiovascular disease. Dietary flavanols can be obtained from the intake of foods such as tea, cocoa, wine, berries and apples. Incorporating Chardonnay Marc (the skins and seeds of Chardonnay grapes) into the diet can be an additional source of dietary flavanols. Like other flavanol-rich foods, Chardonnay Marc provides fiber and polysaccharides that may benefit gut health. This study seeks pilot data on the impact of the daily incorporation of Chardonnay Marc powder into the diet on markers of gut and cardiometabolic health.

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.

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 by-products like grape pomace, which may be similar, have been studied for potential risks, including contamination with harmful compounds like ochratoxin A, a toxin that can pose health risks if consumed in high amounts. ^{1 2 3 4 5}

How is the treatment Chardonnay Marc unique for gut and heart health?

Chardonnay Marc is unique because it is derived from white wine grapes, which typically have fewer flavonoids compared to red wine. This treatment may offer a novel approach by potentially harnessing any unique properties of white wine grape components, which are less studied compared to the well-known cardioprotective effects of red wine flavonoids like resveratrol and quercetin. ^{6 7 8 9 10}

What evidence supports the effectiveness of the treatment Chardonnay Marc for gut and heart health?

Research suggests that moderate wine consumption, particularly red wine, may have heart health benefits due to its antioxidant properties, which are linked to compounds like flavonoids. While Chardonnay Marc is not red wine, it may still contain some beneficial polyphenolic components that could contribute to heart health. ^{6 7 9 11 12}

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

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]

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]

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 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]

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]

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]

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]

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]

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]

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]

Citations

1. Singapore pubmed.ncbi.nlm.nih.gov

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

2. United States pubmed.ncbi.nlm.nih.gov

Alcohol and atherosclerosis: recent insights. [2019]

3. Italy pubmed.ncbi.nlm.nih.gov

The relationship between wine consumption and cardiovascular risk: from epidemiological evidence to biological plausibility. [2011]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. England pubmed.ncbi.nlm.nih.gov

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

6. England pubmed.ncbi.nlm.nih.gov

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

7. England pubmed.ncbi.nlm.nih.gov

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

8. United States 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.). [2023]

9. England 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. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Occurrence of ochratoxin A in wine and grape juice marketed in Rio de Janeiro, Brazil. [2012]

11. Switzerland pubmed.ncbi.nlm.nih.gov

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12. Canada pubmed.ncbi.nlm.nih.gov

Experimental evidence for the cardioprotective effects of red wine. [2021]