Effects of Chardonnay Seed Flour on Vascular Health

Study Overview
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Brief Summary
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This is a randomized, double-blinded trial (Chardonnay seed flour vs. placebo - in pill form) with the purpose to test the impact of a four-month supplementation with Chardonnay Seed Flour (CSF) on endothelial function. Chardonnay flour is made from wine grape skins and seeds. We will examine the effect of CSF on parameters such as endothelial function (via EndoPAT testing), plasma lipid levels, glucose tolerance, insulin resistance, inflammatory markers, oxidative stress surrogates, endothelial progenitor cells (EPCs) as well as the makeup of and impact on the gut microbiome (via stool samples).

Official Title
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Effects of Chardonnay Seed Flour on Vascular Health

Conditions
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1. Endothelial Dysfunction (EndoPAT Score <=2)

Intervention / Treatment
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* Dietary Supplement: Chardonnay Seed Flour (CSF)
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >= 18 years old Demonstrated endothelial dysfunction (EndoPAT score <= 2) at time of screening. Exclusion criteria: Age below 18 or above 80 Endothelial function greater than 2.0 at baseline Hypertension (at screening): any patient with systolic blood pressure (SBP >=170 mmHg or diastolic blood pressure >= 110 mmHg, or hypotension (SBP < 100 mmHg Abnormal liver function tests Uncontrolled Diabetes Mellitus or the use of metformin for Diabetes Mellitus Difficulty swallowing capsules Gastrointestinal disease manifesting with symptoms of malabsorption such as celiac disease or Crohn's disease Non-English speakers Vulnerable populations unable to consent such as prisoners or dependents Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of the CSF including, but not limited to, any of the following: History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy or bowel resection Any history of pancreatic injury, pancreatitis or evidence of impaired pancreatic function/injury as indicated by abnormal lipase or amylase Evidence of hepatic disease as determined by a history of hepatic encephalopathy, a history of cirrhosis, esophageal varices, or a history of portocaval shunt. History of hypersensitivity to any of the study supplement or suspected contraindications to the study supplement. History of noncompliance to medical regimens or unwillingness to comply with the study protocol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Chardonnay Seed Flour (CSF)<br>Prepackaged capsules taken 3 times per day. During the first month, the total dose will be 15 g/d. For months 2-4, the total dose will be 30 g/d. | Dietary Supplement: Chardonnay Seed Flour (CSF)<br>* CSF is made from wine grape skins and seeds.<br>|
| Placebo Comparator: Placebo<br>Pre-packaged capsules taken 3 times per day. For the first month, a total of 15 g/d. During months 2 - 4, a total of 30 g/d. | Dietary Supplement: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial function as measured by reactive hyperemia EndoPAT scores | Endothelial function (Endothelial Peripheral Arterial Tonometry - EndoPAT) Testing will generate a score at baseline that will be compared to a second EndoPAT test which will be conducted again after the study subjects have taken the study product for 4 months. These scores will be used to determine if the study product had an effect on endothelial function. | Baseline to 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in High Sensitive C-reactive protein (hsCRP) |  | Baseline to 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endothelial function