Cardiovascular DiseasesNCT06476795
The Influence of Chardonnay Marc Intake on Gut and Cardiometabolic Health
A study testing Chardonnay Marc in people with Cardiovascular Diseases and Adiposity, run by University of California, Davis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Adiposity, Cardiometabolic Syndrome
- What is being tested?
- Chardonnay Marc
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2024to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 20Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, Davis
Davis, California, 95616
Roberta Holt, PhD, 530-400-5952, rrholt@ucdavis.edu
About this study
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.
Read the 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.
- Conditions
- Cardiovascular Diseases, Adiposity, Cardiometabolic Syndrome
- Being tested
- Chardonnay Marc
- Medical subject headings
- Cardiovascular Diseases, Obesity, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chardonnay MarcOther
Food product made from Chardonnay wine grapes
| Study group | Role | What they receive |
|---|---|---|
| Chardonnay Marc Intake Level 1 | Experimental | Daily intake of Chardonnay marc at 1.5 g Receives: Other: Chardonnay Marc |
| Chardonnay Marc Intake Level 2 | Experimental | Daily intake of Chardonnay marc at 4.5 g Receives: Other: Chardonnay Marc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microvascular function
Microvascular function measured by peripheral arterial tonometry
Measured: 12 weeks
Secondary outcomes (10)
Plasma Cholesterol
Circulating levels of plasma lipids
Measured: 12 weeks
Cytokines
Pro-inflammatory Th17 cytokines
Measured: 12 weeks
short chain fatty acids
Plasma and fecal levels of short chain fatty acids
Measured: 12 weeks
plasma bile acids
Circulating levels of primary and secondary bile acids
Measured: 12 weeks
blood glucose
fasting levels of blood glucose
Measured: 12 weeks
Gene expression
gene expression from whole blood
Measured: 12 weeks
insulin
plasma insulin levels after an overnight fast
Measured: 12 weeks
zonulin
serum and fecal zonulin as a measure of gut permeability
Measured: 12 weeks
lipopolysaccharide binding protein
serum measure of gut permeability
Measured: 12 weeks
Metabolomics
plasma levels of untargeted metabolites
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start1 Jun 2024
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- We will use a two-arm escalation design
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06476795
- Sponsor's protocol ID
- 2034985
- Status last verified
- Aug 2026
- First submitted
- 20 Jun 2024
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Chardonnay Marc Intake on Gut and Cardiometabolic Health
- ClinicalTrials.gov ID
- NCT06476795
- Acronym / sponsor ID
- 2034985
- Conditions
- Cardiovascular Diseases, Adiposity, Cardiometabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 26 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We will use a two-arm escalation design
| Arm | Type | Receives |
|---|---|---|
| Chardonnay Marc Intake Level 1 | Experimental | Other: Chardonnay MarcDaily intake of Chardonnay marc at 1.5 g |
| Chardonnay Marc Intake Level 2 | Experimental | Other: Chardonnay MarcDaily intake of Chardonnay marc at 4.5 g |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chardonnay MarcFood product made from Chardonnay wine grapes | Other | Chardonnay Marc Intake Level 1, Chardonnay Marc Intake Level 2 |
Primary outcome
Microvascular function
Time frame: 12 weeks
Microvascular function measured by peripheral arterial tonometry
10 secondary outcomes
Plasma Cholesterol
Time frame: 12 weeks
Cytokines
Time frame: 12 weeks
short chain fatty acids
Time frame: 12 weeks
plasma bile acids
Time frame: 12 weeks
blood glucose
Time frame: 12 weeks
Gene expression
Time frame: 12 weeks
insulin
Time frame: 12 weeks
zonulin
Time frame: 12 weeks
lipopolysaccharide binding protein
Time frame: 12 weeks
Metabolomics
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chardonnay Marc in people with Cardiovascular Diseases and Adiposity, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roberta R Holt, PhD (5304005952, rrholt@ucdavis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microvascular function (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.