Chardonnay Marc and Vascular Response

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

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Oxidative Stress; Vascular Dilation
• Intervention / Treatment: Other: High Flavanol Cocoa Powder; Other: Vine to Bar Chocolate - 2 servings; Other: Vine to Bar Chocolate - 1 serving; Other: Low Flavanol Cocoa Powder; Other: Vine to Bar Chocolate covered almonds

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 5
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Roberta R Holt; Phone Number: 5304005952; Email: rrholt@ucdavis.edu

Study Locations

• United States
  • California
    • Davis, California, United States, 95616
      • Recruiting
      • Academic Surge, University of California, Davis
      • Contact: Roberta R Holt, PhD; Phone Number: 530-400-5952; Email: rrholt@ucdavis.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Low Flavanol Cocoa Powder; 12 g of Low Flavanol Cocoa Powder (30 mg of cocoa flavanols) provided as a beverage mixed in water	Other: High Flavanol Cocoa Powder; Measure the response 2 and 6 hours post high flavanol cocoa intake; Other: Vine to Bar Chocolate - 2 servings; Measure the response 2 and 6 hours post chocolate intake; Other: Vine to Bar Chocolate - 1 serving; Measure the response 2 and 6 hours post chocolate intake
Experimental: High Flavanol Cocoa Powder; High Flavanol Cocoa Powder (435 mg of flavanols) will be provided as a beverage mixed in water.	Other: Vine to Bar Chocolate - 2 servings; Measure the response 2 and 6 hours post chocolate intake; Other: Vine to Bar Chocolate - 1 serving; Measure the response 2 and 6 hours post chocolate intake; Other: Low Flavanol Cocoa Powder; Measure the response 2 and 6 hours post low flavanol cocoa intake; Other: Vine to Bar Chocolate covered almonds; Measure the response 2 and 6 hours post chocolate covered almond intake
Experimental: Two Servings of Vine to Bar Chocolate; Two servings (60g, 6 pieces) of Vine to Bar Chocolate providing both cocoa flavanols and Chardonnay marc.	Other: Vine to Bar Chocolate - 1 serving; Measure the response 2 and 6 hours post chocolate intake; Other: Vine to Bar Chocolate covered almonds; Measure the response 2 and 6 hours post chocolate covered almond intake
Experimental: One Serving of Vine to Bar Chocolate; A single serving (30g, 3 pieces) of Vine to Bar Chocolate providing both cocoa flavanols and Chardonnay marc.	Other: High Flavanol Cocoa Powder; Measure the response 2 and 6 hours post high flavanol cocoa intake; Other: Vine to Bar Chocolate - 2 servings; Measure the response 2 and 6 hours post chocolate intake; Other: Low Flavanol Cocoa Powder; Measure the response 2 and 6 hours post low flavanol cocoa intake; Other: Vine to Bar Chocolate covered almonds; Measure the response 2 and 6 hours post chocolate covered almond intake
Experimental: Vine to Bar Chocolate covered Almonds; 11 pieces (45g) of Vine to Bar Chocolate providing both cocoa flavanols and Chardonnay marc, with almonds	Other: Vine to Bar Chocolate - 2 servings; Measure the response 2 and 6 hours post chocolate intake; Other: Vine to Bar Chocolate - 1 serving; Measure the response 2 and 6 hours post chocolate intake

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Framingham Reactive Hyperemia Index (fRHI)	measurement of microvascular function using peripheral arterial tonometry (EndoPAT2000)	6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Platelet aggregation	Platelet aggregation after collagen activation will be assessed using platelet aggregometry	6 hours
soluble NADPH oxidase	measure of oxidative stress	6 hours
Glucose	Plasma glucose will be measured	6 hours
Insulin	Serum insulin levels will be measured	6 hours
Total nitrate	circulating levels of nitrate	6 hours

Collaborators and Investigators

• Sponsor: University of California, Davis
• Investigators: Principal Investigator: Carl L Keen, Distinguished Professor Emeritus of Nutrition

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: September 9, 2022
• First Submitted That Met QC Criteria: September 14, 2022
• First Posted (Actual): September 19, 2022

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 1810396

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No