The Influence of Chardonnay Marc Intake on Gut and Cardiometabolic Health

NCT06476795 | Recruiting

• 1 other identifier: 2034985
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiovascular Diseases; Adiposity; Cardiometabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• Microvascular function

  Microvascular function measured by peripheral arterial tonometry

  12 weeks

Secondary Outcomes (10)

• Plasma Cholesterol

  12 weeks

• Cytokines

  12 weeks

• short chain fatty acids

  12 weeks

• plasma bile acids

  12 weeks

• blood glucose

  12 weeks

Study Arms (2)

Chardonnay Marc Intake Level 1

EXPERIMENTAL

Daily intake of Chardonnay marc at 1.5 g

Other: Chardonnay Marc

Chardonnay Marc Intake Level 2

EXPERIMENTAL

Daily intake of Chardonnay marc at 4.5 g

Other: Chardonnay Marc

Interventions

Chardonnay Marc OTHER

Food product made from Chardonnay wine grapes

Chardonnay Marc Intake Level 1; Chardonnay Marc Intake Level 2

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal female, with a cessation of menses for at least 2 years
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California, Davis

Davis, California, 95616, United States

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases; Obesity; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Central Study Contacts

Roberta R Holt, PhD

CONTACT

5304005952; rrholt@ucdavis.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We will use a two-arm escalation design

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: June 26, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)