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NCT Number: NCT06476795

The Influence of Chardonnay Marc Intake on Gut and Cardiometabolic Health

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.

Recruiting

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Key information

Age range

45 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Davis

Davis, California, 95616, United States

Location status: Recruiting

Location contact

Roberta Holt, PhD

CONTACT

[email protected]

530-400-5952

About this study

The overall study objective is to obtain data on the impact of the dietary incorporation of Chardonnay marc on measures of gut and cardiometabolic health. Towards this goal, an escalation design will be employed to examine the effects of 6 - 12 weeks of daily Chardonnay marc intake on markers of gut permeability, inflammation and cardiometabolic health in obese individuals. Study procedures will be performed during 3 study visits conducted at baseline, and after 6 and 12 weeks of Chardonnay Marc intake. For each study visit, 50 ml of blood (~3.5 tbsp) will be collected. For the first six weeks of the study, the participants will be asked to incorporate 1.5 g of Chardonnay Marc into their diet between the hours of 11 am and 4 pm every day. This level of intake will be increased to 4.5 g of Chardonnay marc everyday from weeks 6-12. Therefore, all individuals will consume Chardonnay marc for at least 12 weeks. The participants will be instructed to not cook or add the Chardonnay Marc to hot foods, however, they will be allowed to add the Marc to tepid or warm foods and beverages. They will also be asked to log their intake and how they incorporated the Marc into their diet via a log.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Postmenopausal female, with a cessation of menses for at least 2 years
  • 45-70 years of age
  • BMI 25- 49.9 kg/m2
  • Fasting triglycerides > 120 mg/dL
  • Subject is willing and able to comply with the study protocols and procedures.

Exclusion criteria

  • Self-reported use of daily anticoagulation agents including aspirin, NSAIDs
  • Prescription medications and supplements, except for a 6 month stable dose of thyroid medications
  • Vegan, Vegetarians, food faddists or those consuming a non-traditional diet
  • Fruit consumption ≥ 3 cups/day
  • Vegetable consumption ≥ 4 cups/day
  • Coffee/tea ≥ 3 cups/day
  • Dark chocolate ≥ 3 oz/day
  • Self-reported restriction of physical activity due to a chronic health condition
  • Self-reported chronic/routine high intensity exercise
  • Blood pressure ≥ 140/90 mm Hg
  • Self-reported renal or liver disease
  • Self-reported heart disease, which includes cardiovascular events and stroke, diabetes
  • Peripheral artery disease Raynaud's syndrome or disease
  • Inability to properly place or wear the PAT probes or abnormal measurements on pre-screening PAT
  • Self-reported cancer within past 5 years
  • Self-reported gastrointestinal disorders, apart from appendix removal
  • Unwillingness to stop any supplement use, including herbal, plant or botanical, fish oil, oil supplements six weeks prior to study enrollment.
  • Indications of substance or alcohol abuse within the last 3 years
  • All forms of smoking (e.g. vaping, cigarette, cannabis)
  • Current enrollee in a clinical research study.

Treatment and study plan

Chardonnay Marc

Other

Food product made from Chardonnay wine grapes

Primary outcomes

  1. Microvascular function

    Time frame: 12 weeks

    Microvascular function measured by peripheral arterial tonometry

Secondary outcomes

  1. Plasma Cholesterol

    Time frame: 12 weeks

    Circulating levels of plasma lipids

  2. Cytokines

    Time frame: 12 weeks

    Pro-inflammatory Th17 cytokines

  3. short chain fatty acids

    Time frame: 12 weeks

    Plasma and fecal levels of short chain fatty acids

  4. plasma bile acids

    Time frame: 12 weeks

    Circulating levels of primary and secondary bile acids

  5. blood glucose

    Time frame: 12 weeks

    fasting levels of blood glucose

  6. Gene expression

    Time frame: 12 weeks

    gene expression from whole blood

  7. insulin

    Time frame: 12 weeks

    plasma insulin levels after an overnight fast

  8. zonulin

    Time frame: 12 weeks

    serum and fecal zonulin as a measure of gut permeability

  9. lipopolysaccharide binding protein

    Time frame: 12 weeks

    serum measure of gut permeability

  10. Metabolomics

    Time frame: 12 weeks

    plasma levels of untargeted metabolites

Study contacts

Contact information is provided by the study sponsor or research team.

Roberta R Holt, PhD

CONTACT

[email protected]

5304005952

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 26, 2024
Registry last updated
Jul 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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