Effects of Chardonnay Seed Flour on Vascular Health

Not Applicable

Completed

• Conditions: 1. Endothelial Dysfunction (EndoPAT Score <=2)
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Chardonnay Seed Flour (CSF)

• Registration Number: NCT02093455
• Lead Sponsor: Mayo Clinic

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-18
• Study First Submitted QC: 2014-03-20
• Study First Posted: 2014-03-21
• Primary Completion: 2017-08-23
• Study Completion: 2017-08-23
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-01
• Last Update Posted: 2022-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	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.
Chardonnay Seed Flour (CSF)	Chardonnay Seed Flour (CSF)	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change in High Sensitive C-reactive protein (hsCRP)	Baseline to 4 months

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States