1. Endothelial Dysfunction (EndoPAT Score <=2)
Conditions
Keywords
Endothelial function
Brief summary
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).
Interventions
DIETARY_SUPPLEMENTChardonnay Seed Flour (CSF)
CSF is made from wine grape skins and seeds.
DIETARY_SUPPLEMENTPlacebo
Sponsors
Whole Vine Products
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age \>= 18 years old 2. Demonstrated endothelial dysfunction (EndoPAT score \<= 2) at time of screening.
Exclusion criteria
1. Age below 18 or above 80 2. Endothelial function greater than 2.0 at baseline 3. Hypertension (at screening): any patient with systolic blood pressure (SBP \>=170 mmHg or diastolic blood pressure \>= 110 mmHg, or hypotension (SBP \< 100 mmHg 4. Abnormal liver function tests 5. Uncontrolled Diabetes Mellitus or the use of metformin for Diabetes Mellitus 6. Difficulty swallowing capsules 7. Gastrointestinal disease manifesting with symptoms of malabsorption such as celiac disease or Crohn's disease 8. Non-English speakers 9. Vulnerable populations unable to consent such as prisoners or dependents 10. 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: 1. History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy or bowel resection 2. Any history of pancreatic injury, pancreatitis or evidence of impaired pancreatic function/injury as indicated by abnormal lipase or amylase 3. Evidence of hepatic disease as determined by a history of hepatic encephalopathy, a history of cirrhosis, esophageal varices, or a history of portocaval shunt. 11. History of hypersensitivity to any of the study supplement or suspected contraindications to the study supplement. 12. History of noncompliance to medical regimens or unwillingness to comply with the study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endothelial function as measured by reactive hyperemia EndoPAT scores | Baseline to 4 months | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Change in High Sensitive C-reactive protein (hsCRP) | Baseline to 4 months |
Countries
United States
Outcome results
None listed