Chardonnay Marc and Vascular Response
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.
Conditions:
🦠 Cardiovascular Diseases 🦠 Vascular Dilation 🦠 Oxidative Stress
🗓️ Study Start (Actual) 1 September 2022
🗓️ Primary Completion (Estimated) 31 December 2024
✅ Study Completion (Estimated) 31 December 2024
👥 Enrollment (Estimated) 5
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Davis, California, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * 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

    Exclusion Criteria:

    • * 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
    • * 1 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
    • * Self-reported restriction of physical activity due to a chronic health condition
    • * Self-reported chronic/routine high intensity exercise
    • * Self-reported diabetes
    • * Blood pressure ≥ 140/90 mm Hg
    • * Self-reported renal or liver disease
    • * Self-reported heart disease, which includes cardiovascular events and stroke
    • * Peripheral artery disease, Raynaud's syndrome
    • * 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 malabsorption
    • * Currently taking prescription drugs or supplements.
    • * Supplement use or unwillingness to stop any supplement use, including herbal, plant or botanical, fish oil, oil supplements a month prior to study enrollment.
    • * Indications of substance or alcohol abuse within the last 3 years
    • * smoking, vaping, cannabis use
    • * Current enrollee in a clinical research study.
Ages Eligible for Study: 30 Years to 50 Years (ADULT)
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 9 September 2022
  • First Submitted that Met QC Criteria 14 September 2022
  • First Posted 19 September 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 15 March 2024
  • Last Update Posted 18 March 2024
  • Last Verified March 2024