RECRUITING

Chardonnay Marc and Vascular Response

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Conditions

Cardiovascular DiseasesVascular DilationOxidative Stress

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Preclinical Trials to Determine the Range of Chardonnay Mark Intake for Improved Metabolic and Vascular Response.

Quick Facts

Study Start:2022-09-01
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05545865

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Years to 50 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Screening or Visit 1 Reactive Hyperemia Index (RHI; EndoPAT 2000) \< 2.0
  2. * Subject is willing and able to comply with the study protocols.
  3. * Subject is willing to participate in all study procedures
  4. * BMI 25.0 - 35 kg/m2
  1. * BMI ≥ 35 kg/m2
  2. * Indivduals that weight less than a 110 lbs
  3. * Donation of blood within the previous 30 days
  4. * Visit 1 Reactive Hyperemia Index (RHI; EndoPAT 2000) ≥ 2.0
  5. * 1 ug/ml and 3 ug/ml collagen screening maximal platelet aggregatory response of \< 65%.
  6. * Platelet counts \< 150,000 / ul
  7. * 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.
  8. * Dislike or allergy for nuts, cocoa or grape products
  9. * Self-reported use of daily anticoagulation agents including aspirin, NSAIDs
  10. * Vegan, Vegetarians, food faddists or those consuming a non-traditional diet
  11. * Fruit consumption ≥ 3 cups/day
  12. * Vegetable consumption ≥ 4 cups/day
  13. * Nut intake ≥ 2 servings/ week
  14. * Coffee/tea ≥ 3 cups/day
  15. * Dark chocolate ≥ 3 oz/day
  16. * Self-reported restriction of physical activity due to a chronic health condition
  17. * Self-reported chronic/routine high intensity exercise
  18. * Self-reported diabetes
  19. * Blood pressure ≥ 140/90 mm Hg
  20. * Self-reported renal or liver disease
  21. * Self-reported heart disease, which includes cardiovascular events and stroke
  22. * Peripheral artery disease, Raynaud's syndrome
  23. * Inability to properly place or wear the PAT probes or abnormal measurements on pre- screening PAT
  24. * Self-reported cancer within past 5 years
  25. * Self-reported malabsorption
  26. * Currently taking prescription drugs or supplements.
  27. * Supplement use or unwillingness to stop any supplement use, including herbal, plant or botanical, fish oil, oil supplements a month prior to study enrollment.
  28. * Indications of substance or alcohol abuse within the last 3 years
  29. * smoking, vaping, cannabis use
  30. * Current enrollee in a clinical research study.

Contacts and Locations

Study Contact

Roberta R Holt
CONTACT
5304005952
rrholt@ucdavis.edu

Principal Investigator

Carl L Keen
PRINCIPAL_INVESTIGATOR
Distinguished Professor Emeritus of Nutrition

Study Locations (Sites)

Academic Surge, University of California, Davis
Davis, California, 95616
United States

Collaborators and Investigators

Sponsor: University of California, Davis

  • Carl L Keen, PRINCIPAL_INVESTIGATOR, Distinguished Professor Emeritus of Nutrition

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

Study Start Date2022-09-01
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2022-09-01
Study Completion Date2024-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Cardiovascular Diseases
  • Vascular Dilation
  • Oxidative Stress