Chardonnay Marc for Gut and Heart Health
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of California, Davis
Must not be taking: Anticoagulants, NSAIDs, Supplements
Disqualifiers: Vegan, Heart disease, Cancer, others
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
678910How 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.
2451112Eligibility Criteria
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.
+2 more
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
+17 more
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: Chardonnay Marc Intake Level 2Experimental Treatment1 Intervention
Daily intake of Chardonnay marc at 4.5 g
Group II: Chardonnay Marc Intake Level 1Experimental Treatment1 Intervention
Daily intake of Chardonnay marc at 1.5 g
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of California, DavisDavis, CA
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Who Is Running the Clinical Trial?
University of California, DavisLead Sponsor
References
Alcohol, heart disease, and mortality: a review. [2007]Observational data suggest that moderate alcohol consumption is associated with reduced all-cause mortality compared with that associated with either abstinence or heavy drinking. Alcohol consumption reduces cardiovascular disease risk primarily by increasing production of high-density lipoprotein cholesterol, and possibly by increasing plasminogen, tissue plasminogen activator, and endothelial function, and decreasing platelet aggregability, fibrinogen, and lipoprotein(a). Red wine, containing antioxidants, has been purported to be especially cardioprotective. However, red wine consumption is not associated with reduced all-cause mortality in European countries, and American studies have found no relationship between the type of alcohol consumed and cardiovascular risk. Alcohol appears to be more cardioprotective if consumed with meals (possibly owing to protection against postprandial endothelial protection) and in moderation daily (as opposed to binge drinking). Despite the wealth of observational data, it is not absolutely clear that alcohol reduces cardiovascular risk, because no randomized controlled trials have been performed. Alcohol should never be recommended to patients to reduce cardiovascular risk as a substitute for the well-proven alternatives of appropriate diet, exercise, and drugs. Alcohol remains the number three cause of preventable premature death in this country, and the risk of alcohol habituation, abuse, and adverse effects must be considered in any patient counseling.
Alcohol and atherosclerosis: recent insights. [2019]Light to moderate alcohol intake is known to have cardioprotective properties; however, the magnitude of protection depends on other factors and may be confined to some subsets of the population. This review focuses on factors that modify the relationship between alcohol and coronary heart disease (CHD). The cardioprotective effect of alcohol seems to be larger among middle-aged and elderly adults than among young adults, who do not have a net beneficial effect of a light to moderate alcohol intake in terms of reduced all-cause mortality. The levels of alcohol at which the risk of CHD is lowest and the levels of alcohol at which the risk of CHD exceeds the risk among abstainers are lower for women than for men. The pattern of drinking seems important for the apparent cardioprotective effect of alcohol, and the risk of CHD is generally lower for steady versus binge drinking. Finally, there is some evidence that wine may have more beneficial effects than beer and distilled spirits; however, these results are still controversial and may be confounded by personal characteristics and other lifestyle factors such as diet. The inverse association between alcohol intake and CHD is influenced by age, gender, drinking pattern, and possibly by type of alcohol.
The relationship between wine consumption and cardiovascular risk: from epidemiological evidence to biological plausibility. [2011]Epidemiological studies have suggested that cardiovascular disease morbidity and mortality can be decreased by moderate alcohol consumption. Several recent studies have also separately assessed the relative risk associated with different types of alcoholic beverages. The evidence obtained strongly suggests, although does not prove, that there is a major beneficial effect from drinking a low-moderate amount of wine. A meta-analysis has recently been performed on 19 of these studies, selected on the basis of the availability of specific information on the relative risk associated with wine consumption. The results indicate a negative association of moderate (up to 300 ml per day) wine consumption with the risk of cardiovascular events. Although some cardioprotective effects of alcoholic beverages are probably due to ethanol-induced elevation of HDL cholesterol, lowering of fibrinogen plasma levels and, perhaps, of platelet aggregation, it is reasonable to speculate that the cardiovascular protective effects of wine, observed in French and in other populations, may be attributed in part to the antioxidant, vasorelaxant, and antithrombotic properties of its polyphenolic components.
Alcohol, ischemic heart disease, and the French paradox. [2023]Many studies have shown either an inverse relation between alcohol intake and ischemic heart disease or a U-shaped curve in which the equivalent of two drinks per day of any kind of alcohol is associated with a decreased incidence of coronary disease compared with no drinks, while higher doses result in an increased risk of infarction and stroke. Although the cardioprotective effects of most alcoholic beverages are probably due to an elevation of high-density lipoprotein as well as the ability of alcohol to prevent platelet aggregation and increased fibrinolysis, there is an increased favorable effect of red wine. The unique cardioprotective properties of red wine reside in the action of flavonoids which are absent in white wine (with the exception of champagne) and sparse in beer (with the exception of dark beers). The best research flavonoids are resveritrol and quercetin, which confer antioxidant properties more potent than alpha-tocopherol. Grape juice has about half the amount of flavonoids by volume as does red wine.
Alcohol, ischemic heart disease, and the French paradox. [2019]Studies comparing alcohol intake and ischemic heart disease have shown either an inverse relation or a U-shaped curve in which the equivalent of two drinks per day of any kind of alcohol is associated with a decreased incidence of coronary disease compared with no drinks, while higher doses result in an increased risk of infarction and stroke. The cardioprotective effects of most alcoholic beverages are probably due to an elevation of high-density lipoprotein and the ability of alcohol to prevent platelet aggregation and increase fibrinolysis; however, there is an increased favorable effect from red wine. The unique cardioprotective properties of red wine reside in the action of flavonoids which are minimal in white wine (with the exception of champagne). The best researched flavonoids are resveratrol and quercetin, which confer antioxidant properties more potent than alpha-tocopherol. Grape juice has about half the amount of flavonoids by volume as red wine.
Plant Food Supplements with Antioxidant Properties for the Treatment of Chronic and Neurodegenerative Diseases: Benefits or Risks? [2017]Wine by-products, in particular grape pomace, can be an important source of polyphenols and dietary fibers and are increasingly being used as a starting material in the industrial production of plant food supplements, such as other matrices containing biomolecules, with antioxidant properties. The risk associated with the consumption of these products was recently analyzed through a study of potential genotoxic and carcinogenic compounds that can be found in the marketed products. In particular, occurrence data about contamination with the mycotoxin ochratoxin A were also reported. This short review aims at giving an overview about the quality and benefits of these kinds of food supplements, and also about risks of incorrect use, focusing on the emerging need for stricter European regulations.
Antidotal effect of grape juice (Vitis vinifera) on ochratoxin A caused hepatorenal carcinogenesis in mice (Mus musculus). [2013]Oral administration of ochratoxin A to young weanling mice (Mus musculus) caused several haematological changes and induced hepatoma and renal carcinoma. Concurrent administration of berry and leaf juice of the common grape (Vitis vinifera) to mice together with ochratoxin A significantly reduced the hepatic and renal damage caused by ingestion of this mycotoxin. None of the animals receiving berry/leaf juice of V. vinifera showed the formation of hepatorenal carcinoma whereas 25% of animals receiving only ochratoxin A developed well differentiated renal carcinoma and hepatic lesions.
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]Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of l-valine produced by fermentation using a non-genetically modified strain of Corynebacterium glutamicum (CGMCC 18932). l-Valine is intended to be used in feed and water for drinking as a nutritional additive, functional group amino acids, their salts and analogues, for all animal species and categories. The production strain is considered suitable for the qualified presumption of safety (QPS) approach to safety assessment. The FEEDAP Panel concluded that l-valine produced by C. glutamicum CGMCC 18932 is considered safe for the target species when supplemented to the diet in appropriate amounts according to the nutritional needs of the target species. The use of l-valine produced using C. glutamicum CGMCC 18932 in animal nutrition is considered safe for the consumer and for the environment. No conclusion could be drawn on the potential of l-valine produced using C. glutamicum CGMCC 18932 to be irritant to the skin or eyes, or a dermal sensitiser due to the lack of data. The FEEDAP Panel concluded that the l-valine produced by fermentation using C. glutamicum CGMCC 18932 is an efficacious source of the essential amino acid l-valine for non-ruminant nutrition. To be as efficacious in ruminants as in non-ruminants, supplemental l-valine requires protection against ruminal degradation. The FEEDAP Panel expressed concerns on the use of amino acids in water for drinking for hygienic reasons.
Exposure risk assessment to ochratoxin A through consumption of juice and wine considering the effect of steam extraction time and vinification stages. [2018]The goals of this study were (i) to verify the effect of steam extraction used in juice production and the stages of vinification on the ochratoxin A (OTA) levels found in grapes naturally contaminated, and (ii) evaluate the risk of exposure to this toxin when the daily consumption of juice and wine is followed to prevent cardiovascular disease. OTA-producing fungi were isolated from Cabernet Sauvignon, Moscato Itálico and Concord grapes harvested from the same vineyard and intended to produce red wine, white wine and juice, respectively. The highest levels of this toxin were found in the Concord grapes used for juice production. Although greater reduction in OTA levels occurred during juice production (73%) compared to winemaking (66 and 44%, for red and white, respectively), the estimated OTA exposure through juice was higher than the tolerable intake established for this toxin by JECFA. The risk associated with juice consumption, rather than wine, can be explained by (i) higher OTA levels found in Concord must than those of Cabernet and Moscato, indicating that Concord grapes appear to be more susceptible to OTA production by toxigenic fungi; and (ii) the daily recommended juice consumption is higher than those proposed to red wine.
Occurrence of ochratoxin A in wine and grape juice marketed in Rio de Janeiro, Brazil. [2012]Ochratoxin A (OA) is receiving attention world-wide because of the hazard it poses to human health. The aim was to test the distribution of OA in grape juice, pulps of frozen grapes, and national and imported table wine obtained from markets in Rio de Janeiro, Brazil. Analytical methodology using immunoaffinity column for OA extraction and clean-up with a final separation on a reversed-phase (C(18)) column and fluorescence detection in high-performance liquid chromatography showed a detection limit of 21 ng l(-1). The mean recovery was 91% for red wines and 82% for white wines; while the mean recoveries for juices and pulps of frozen grapes were 91.6 and 88%, respectively. Of 64 samples of grape juice and frozen pulps, 25% were positive for OA, being the mean content of 37 ng l(-1) with a maximum concentration of 100 ng l(-1). In wines, the mean concentration detected in 80 samples analysed was 34.4 ng l(-1) with 28.75% of positive samples. Red wines showed the highest percentages and levels of contaminated samples: 38% and 37 ng l(-1), respectively. The white wine contained levels above 26 ng l(-1) in 17.75% of the analysed samples. The levels of contamination detected in red wine sold in Río de Janeiro were not enough to surpass the virtually safe dose established as 5 n g kg(-1) body weight of daily intake.
The mediterranean lecture: wine and thrombosis--from epidemiology to physiology and back. [2017]The protective effect of moderate alcohol consumption on the risk of cardiovascular disease has been consistently shown in many epidemiological studies. Antiatherogenic alterations in plasma lipoproteins, particularly increase in high-density lipoprotein (HDL) cholesterol,are considered as the most plausible mechanism of the protective effect of alcohol consumption on coronary artery disease (CHD). Other potential mechanisms contributing to the cardio-protective effects of moderate alcohol consumption include anti-thrombotic down regulation of blood platelet function, as well as of the coagulation and fibrinolysis balance. Since the proposal of a "French paradox" in the early Nineties, the possibility that consuming alcohol in the form of wine might confer a protection against CHD above that expected from its alcohol content, has made the topic"wine and health" increasingly popular. Many epidemiological studies have explored such a possibility, by comparing specific alcoholic beverage types (wine,beer, liqueur) in respect to their relative capacity to reduce the risk of CHD. In parallel, experimental studies have been done, in which wine and wine-derived products have been tested for their capacity to interfere with molecular and cellular mechanisms relevant to the pathogenesis of CHD. Wine might indeed conceivably have other ethanol unrelated beneficial effects. The biological rationale for such a hypothesis has been linked to the enrichment in grape-derived, non-alcoholic components, that possibly make it peculiar in respect to other alcoholic beverages. In fact, while the mechanisms underlying the effects of alcohol on cardiovascular disease have been limited to lipid metabolism and the haemostatic system, those related to wine consumption have also been extended to specific anti-inflammatory, antioxidant and nitric oxide related vaso-relaxant properties of its polyphenolic constituents. The effect of wine consumption has been carefully investigated to account for potential confounding of several conditions (inappropriate use of abstainers as control population, correlation between wine or total alcohol consumption and markers of healthy lifestyle and socioeconomic factors, diet, etc.). Strong evidence indicates that moderate wine consumption rather than confounders reduces both fatal and non fatal CHD events. In spite of the fact that the healthy effect of moderate intake of wine is by now well accepted, important issues remain to be resolved about the relationship between wine, alcohol and alcoholic beverages, the (possibly different) optimal amount of alcohol intake in men and women, the individual or environmental modulation of the alcohol related effect and the pattern of drinking. Some of these issues have been recently addressed in a large meta-analysis, in which the relationship between wine or beer consumption and CHD risk was quantitatively evaluated. We shall summarize here the experimental and epidemiological studies with wine or wine-derived products aimed at finding biological explanations for the supposed superior cardio-protective effects of wine consumption and to discuss some open questions about wine and vascular disease as approached in epidemiological studies.
Experimental evidence for the cardioprotective effects of red wine. [2021]Both epidemiological and experimental studies have revealed that intake of wine, particularly red wine, in moderation protects cardiovascular health; however, the experimental basis for such an action is not fully understood. Because all types of red wine contain varying amounts of alcohol and antioxidants, it is likely that the cardioprotective effect of red wine is due to both these constituents. In view of its direct action on the vascular smooth muscle cells, alcohol may produce coronary vasodilation in addition to attenuating oxidative stress by its action on the central nervous system. The antioxidant components of red wine may provide cardioprotection by their ability to reduce oxidative stress in the heart under different pathological conditions. Mild-to-moderate red wine consumption improves cardiac function in the ischemic myocardium through the protection of endothelial function, the expression of several cardioprotective oxidative stress-inducible proteins, as well as the activation of adenosine receptors and nitrous oxide synthase mechanisms.