Health TrialsbyHealthPanel

Chardonnay Marc and Vascular Response

ConditionsCardiovascular DiseasesVascular DilationOxidative Stress
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age30-50
SponsorUniversity of California, Davis

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Low Flavanol Cocoa Powder

    Other intervention

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

  • High Flavanol Cocoa Powder

    Other intervention

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

  • Vine to Bar Chocolate - 2 servings

    Other intervention

    Measure the response 2 and 6 hours post chocolate intake

  • Vine to Bar Chocolate - 1 serving

    Other intervention

    Measure the response 2 and 6 hours post chocolate intake

  • Vine to Bar Chocolate covered almonds

    Other intervention

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

Treatment groups

5 Participants
are divided into 5 treatment groups
Group A: Low Flavanol Cocoa PowderPlacebo comparator 3 interventions
Group B: High Flavanol Cocoa PowderExperimental treatment 4 interventions
Group C: Two Servings of Vine to Bar ChocolateExperimental treatment 2 interventions
Group D: One Serving of Vine to Bar ChocolateExperimental treatment 4 interventions
Group E: Vine to Bar Chocolate covered AlmondsExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Framingham Reactive Hyperemia Index (fRHI)

measurement of microvascular function using peripheral arterial tonometry (EndoPAT2000)

Time frame
6 hours

Secondary outcomes

1

Platelet aggregation

Platelet aggregation after collagen activation will be assessed using platelet aggregometry

Time frame
6 hours
2

soluble NADPH oxidase

measure of oxidative stress

Time frame
6 hours
3

Glucose

Plasma glucose will be measured

Time frame
6 hours
4

Insulin

Serum insulin levels will be measured

Time frame
6 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Davis

Lead sponsor

Source ClinicalTrials.gov
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