Effects of Chardonnay Seed Flour on Vascular Health

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2017-08-23

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).

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Detailed Description

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Conditions

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1. Endothelial Dysfunction (EndoPAT Score <=2)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Chardonnay Seed Flour (CSF)

Intervention Type DIETARY_SUPPLEMENT

CSF is made from wine grape skins and seeds.

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Chardonnay Seed Flour (CSF)

CSF is made from wine grape skins and seeds.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No