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| Name | Class |
|---|---|
| Whole Vine Products | UNKNOWN |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chardonnay Seed Flour (CSF) | Active Comparator | 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. |
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| Placebo | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chardonnay Seed Flour (CSF) | Dietary Supplement | CSF is made from wine grape skins and seeds. |
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| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in High Sensitive C-reactive protein (hsCRP) | Baseline to 4 months |
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Inclusion Criteria:
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 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
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| Name | Affiliation | Role |
|---|---|---|
| Amir Lerman, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32067098 | Derived | Corban MT, Widmer RJ, Cilluffo R, Kazeck MA, Lennon RJ, Lerman LO, Lerman A. The effect of polyphenol-rich chardonnay seed supplements on peripheral endothelial function. Eur J Nutr. 2020 Dec;59(8):3723-3734. doi: 10.1007/s00394-020-02203-6. Epub 2020 Feb 17. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| Placebo | Dietary Supplement |
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