Chardonnay Marc and Vascular Response

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05545865
• Other study ID #: 1810396
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: University of California, Davis
• Contact: Roberta R Holt
• Phone: 5304005952
• Email: rrholt[@]ucdavis.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The current set of trials will be of an acute (single intake, followed over 6 hours) that examines the postprandial response of individuals to the products. These preclinical trials will be conducted in the same individuals in an crossover design in order to limit individual variability, and keep the numbers small (5 individuals maximum), but still be able to assess the response to the different products.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Oxidative Stress
• Vascular Dilation

Intervention

Other:
• Low Flavanol Cocoa Powder
Measure the response 2 and 6 hours post low flavanol cocoa intake
• High Flavanol Cocoa Powder
Measure the response 2 and 6 hours post high flavanol cocoa intake
• Vine to Bar Chocolate - 2 servings
Measure the response 2 and 6 hours post chocolate intake
• Vine to Bar Chocolate - 1 serving
Measure the response 2 and 6 hours post chocolate intake
• Vine to Bar Chocolate covered almonds
Measure the response 2 and 6 hours post chocolate covered almond intake

Locations

Country	Name	City	State
United States	Academic Surge, University of California, Davis	Davis	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Framingham Reactive Hyperemia Index (fRHI)	measurement of microvascular function using peripheral arterial tonometry (EndoPAT2000)	6 hours
Secondary	Platelet aggregation	Platelet aggregation after collagen activation will be assessed using platelet aggregometry	6 hours
Secondary	soluble NADPH oxidase	measure of oxidative stress	6 hours
Secondary	Glucose	Plasma glucose will be measured	6 hours
Secondary	Insulin	Serum insulin levels will be measured	6 hours
Secondary	Total nitrate	circulating levels of nitrate	6 hours