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OpenTrials
Completed

NCT Number: NCT02093455

Effects of Chardonnay Seed Flour on Vascular Health

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >= 18 years old
  • Demonstrated endothelial dysfunction (EndoPAT score <= 2) at time of screening.

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 major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy or bowel resection
  • Any history of pancreatic injury, pancreatitis or evidence of impaired pancreatic function/injury as indicated by abnormal lipase or amylase
  • Evidence of hepatic disease as determined by a history of hepatic encephalopathy, a history of cirrhosis, esophageal varices, or a history of portocaval shunt.
  • 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

Treatment and study plan

Chardonnay Seed Flour (CSF)

Dietary Supplement

CSF is made from wine grape skins and seeds.

Placebo

Dietary Supplement

Primary outcomes

  1. Endothelial function as measured by reactive hyperemia EndoPAT scores

    Time frame: 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 outcomes

  1. Change in High Sensitive C-reactive protein (hsCRP)

    Time frame: Baseline to 4 months

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Whole Vine Products

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Mar 21, 2014
Registry last updated
Feb 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.