Chardonnay Marc and Vascular Response

NCT ID: NCT05545865

Last Updated: 2025-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2025-08-24

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cardiovascular Diseases Vascular Dilation Oxidative Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Acute crossover design
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators
Low and High flavanol cocoa will be provided in coded packaging.

Study Groups

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Low Flavanol Cocoa Powder

12 g of Low Flavanol Cocoa Powder (30 mg of cocoa flavanols) provided as a beverage mixed in water

Group Type PLACEBO_COMPARATOR

High Flavanol Cocoa Powder

Intervention Type OTHER

Measure the response 2 and 6 hours post high flavanol cocoa intake

Vine to Bar Chocolate - 2 servings

Intervention Type OTHER

Measure the response 2 and 6 hours post chocolate intake

Vine to Bar Chocolate - 1 serving

Intervention Type OTHER

Measure the response 2 and 6 hours post chocolate intake

High Flavanol Cocoa Powder

High Flavanol Cocoa Powder (435 mg of flavanols) will be provided as a beverage mixed in water.

Group Type EXPERIMENTAL

Low Flavanol Cocoa Powder

Intervention Type OTHER

Measure the response 2 and 6 hours post low flavanol cocoa intake

Vine to Bar Chocolate - 2 servings

Intervention Type OTHER

Measure the response 2 and 6 hours post chocolate intake

Vine to Bar Chocolate - 1 serving

Intervention Type OTHER

Measure the response 2 and 6 hours post chocolate intake

Vine to Bar Chocolate covered almonds

Intervention Type OTHER

Measure the response 2 and 6 hours post chocolate covered almond intake

Two Servings of Vine to Bar Chocolate

Two servings (60g, 6 pieces) of Vine to Bar Chocolate providing both cocoa flavanols and Chardonnay marc.

Group Type EXPERIMENTAL

Vine to Bar Chocolate - 1 serving

Intervention Type OTHER

Measure the response 2 and 6 hours post chocolate intake

Vine to Bar Chocolate covered almonds

Intervention Type OTHER

Measure the response 2 and 6 hours post chocolate covered almond intake

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.

Group Type EXPERIMENTAL

Low Flavanol Cocoa Powder

Intervention Type OTHER

Measure the response 2 and 6 hours post low flavanol cocoa intake

High Flavanol Cocoa Powder

Intervention Type OTHER

Measure the response 2 and 6 hours post high flavanol cocoa intake

Vine to Bar Chocolate - 2 servings

Intervention Type OTHER

Measure the response 2 and 6 hours post chocolate intake

Vine to Bar Chocolate covered almonds

Intervention Type OTHER

Measure the response 2 and 6 hours post chocolate covered almond intake

Vine to Bar Chocolate covered Almonds

11 pieces (45g) of Vine to Bar Chocolate providing both cocoa flavanols and Chardonnay marc, with almonds

Group Type EXPERIMENTAL

Vine to Bar Chocolate - 2 servings

Intervention Type OTHER

Measure the response 2 and 6 hours post chocolate intake

Vine to Bar Chocolate - 1 serving

Intervention Type OTHER

Measure the response 2 and 6 hours post chocolate intake

Interventions

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Low Flavanol Cocoa Powder

Measure the response 2 and 6 hours post low flavanol cocoa intake

Intervention Type OTHER

High Flavanol Cocoa Powder

Measure the response 2 and 6 hours post high flavanol cocoa intake

Intervention Type OTHER

Vine to Bar Chocolate - 2 servings

Measure the response 2 and 6 hours post chocolate intake

Intervention Type OTHER

Vine to Bar Chocolate - 1 serving

Measure the response 2 and 6 hours post chocolate intake

Intervention Type OTHER

Vine to Bar Chocolate covered almonds

Measure the response 2 and 6 hours post chocolate covered almond intake

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carl L Keen

Role: PRINCIPAL_INVESTIGATOR

Distinguished Professor Emeritus of Nutrition

Locations

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Academic Surge, University of California, Davis

Davis, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Roberta R Holt

Role: CONTACT

5304005952

Facility Contacts

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Roberta R Holt, PhD

Role: primary

530-400-5952

Other Identifiers

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1810396

Identifier Type: -

Identifier Source: org_study_id

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