Chardonnay Marc and Vascular Response
Preclinical Trials to Determine the Range of Chardonnay Mark Intake for Improved Metabolic and Vascular Response.
1 other identifier
interventional
5
1 country
1
Brief Summary
This study aims to obtain data on the potential influence of Vine to Bar product(s) containing Chardonnay marc on cardiometabolic health. These initial studies will inform the design and timing of data collection for future dietary intervention trials that will examine the influence of Chardonnay marc intake on outcomes/biomarkers of both cardiometabolic health and the gut microbiome. This includes collecting data on the potential differences in response to the products based on the unique food matrix for each of the products that will be tested. Moreover, as there is a paucity of data on the influence of cocoa flavanol intake on vascular function beyond 4 hours post intake, the response of the selected outcomes will be assessed after 6 hours of flavanol intake. This is a time point that captures the increased circulating presence of microbial derived flavanol metabolites.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable cardiovascular-diseases
Started Sep 2022
Typical duration for not_applicable cardiovascular-diseases
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2022
CompletedFirst Submitted
Initial submission to the registry
September 9, 2022
CompletedFirst Posted
Study publicly available on registry
September 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 24, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 24, 2026
February 18, 2026
February 1, 2026
4 years
September 9, 2022
February 13, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Framingham Reactive Hyperemia Index (fRHI)
measurement of microvascular function using peripheral arterial tonometry (EndoPAT2000)
6 hours
Secondary Outcomes (5)
Platelet aggregation
6 hours
soluble NADPH oxidase
6 hours
Glucose
6 hours
Insulin
6 hours
Total nitrate
6 hours
Study Arms (5)
Low Flavanol Cocoa Powder
PLACEBO COMPARATOR12 g of Low Flavanol Cocoa Powder (30 mg of cocoa flavanols) provided as a beverage mixed in water
High Flavanol Cocoa Powder
EXPERIMENTALHigh Flavanol Cocoa Powder (435 mg of flavanols) will be provided as a beverage mixed in water.
Two Servings of Vine to Bar Chocolate
EXPERIMENTALTwo servings (60g, 6 pieces) of Vine to Bar Chocolate providing both cocoa flavanols and Chardonnay marc.
One Serving of Vine to Bar Chocolate
EXPERIMENTALA single serving (30g, 3 pieces) of Vine to Bar Chocolate providing both cocoa flavanols and Chardonnay marc.
Vine to Bar Chocolate covered Almonds
EXPERIMENTAL11 pieces (45g) of Vine to Bar Chocolate providing both cocoa flavanols and Chardonnay marc, with almonds
Interventions
Measure the response 2 and 6 hours post low flavanol cocoa intake
Measure the response 2 and 6 hours post high flavanol cocoa intake
Measure the response 2 and 6 hours post chocolate intake
Measure the response 2 and 6 hours post chocolate intake
Measure the response 2 and 6 hours post chocolate covered almond intake
Eligibility Criteria
You may qualify if:
- Screening or Visit 1 Reactive Hyperemia Index (RHI; EndoPAT 2000) \< 2.0
- Subject is willing and able to comply with the study protocols.
- Subject is willing to participate in all study procedures
- BMI 25.0 - 35 kg/m2
You may not qualify if:
- BMI ≥ 35 kg/m2
- Indivduals that weight less than a 110 lbs
- Donation of blood within the previous 30 days
- Visit 1 Reactive Hyperemia Index (RHI; EndoPAT 2000) ≥ 2.0
- ug/ml and 3 ug/ml collagen screening maximal platelet aggregatory response of \< 65%.
- Platelet counts \< 150,000 / ul
- Anemia, which includes self report, or a screening hemoglobin and hematocrit that is less than the normal reference range or as diagnosed by study physician upon review of complete blood cell count reports.
- Dislike or allergy for nuts, cocoa or grape products
- Self-reported use of daily anticoagulation agents including aspirin, NSAIDs
- Vegan, Vegetarians, food faddists or those consuming a non-traditional diet
- Fruit consumption ≥ 3 cups/day
- Vegetable consumption ≥ 4 cups/day
- Nut intake ≥ 2 servings/ week
- Coffee/tea ≥ 3 cups/day
- Dark chocolate ≥ 3 oz/day
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Academic Surge, University of California, Davis
Davis, California, 95616, United States
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Carl L Keen
Distinguished Professor Emeritus of Nutrition
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Low and High flavanol cocoa will be provided in coded packaging.
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2022
First Posted
September 19, 2022
Study Start
September 1, 2022
Primary Completion (Estimated)
August 24, 2026
Study Completion (Estimated)
August 24, 2026
Last Updated
February 18, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share