Effects of Chardonnay Seed Flour on Vascular Health

Mayo Clinic

Status: Completed

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

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Chardonnay Seed Flour (CSF)

Study type: Interventional

Funder types: Other

Identifiers

NCT02093455

13-007023

Details and patient eligibility

About

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).

Enrollment: 168 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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168 participants in 2 patient groups, including a placebo group

Chardonnay Seed Flour (CSF)

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Chardonnay Seed Flour (CSF)

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo