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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Adiposity; Cardiometabolic Syndrome
• Intervention / Treatment: Other: Chardonnay Marc

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 5
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Roberta R Holt, PhD; Phone Number: 5304005952; Email: rrholt@ucdavis.edu

Study Locations

• United States
  • California
    • Davis, California, United States, 95616
      • Recruiting
      • University of California, Davis
      • Contact: Roberta Holt, PhD; Phone Number: 530-400-5952; Email: rrholt@ucdavis.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chardonnay Marc Intake Level 1; Daily intake of Chardonnay marc at 1.5 g	Other: Chardonnay Marc; Food product made from Chardonnay wine grapes
Experimental: Chardonnay Marc Intake Level 2; Daily intake of Chardonnay marc at 4.5 g	Other: Chardonnay Marc; Food product made from Chardonnay wine grapes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microvascular function	Microvascular function measured by peripheral arterial tonometry	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma Cholesterol	Circulating levels of plasma lipids	12 weeks
Cytokines	Pro-inflammatory Th17 cytokines	12 weeks
short chain fatty acids	Plasma and fecal levels of short chain fatty acids	12 weeks
plasma bile acids	Circulating levels of primary and secondary bile acids	12 weeks
blood glucose	fasting levels of blood glucose	12 weeks
Gene expression	gene expression from whole blood	12 weeks
insulin	plasma insulin levels after an overnight fast	12 weeks
zonulin	serum and fecal zonulin as a measure of gut permeability	12 weeks
lipopolysaccharide binding protein	serum measure of gut permeability	12 weeks
Metabolomics	plasma levels of untargeted metabolites	12 weeks

Collaborators and Investigators

• Sponsor: University of California, Davis

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: June 20, 2024
• First Submitted That Met QC Criteria: June 25, 2024
• First Posted (Actual): June 26, 2024

Study Record Updates

• Last Update Posted (Actual): July 10, 2025
• Last Update Submitted That Met QC Criteria: July 7, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Glucose Metabolism Disorders; Insulin Resistance; Hyperinsulinism; Cardiovascular Diseases; Metabolic Syndrome
• Other Study ID Numbers: 2034985

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No