Clinical trial NCT02093455: Effects of Chardonnay Seed Flour on Vascular Health
Official title: Effects of Chardonnay Seed Flour on Vascular Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 1. Endothelial Dysfunction (EndoPAT Score <=2)
Keywords: Endothelial function
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Whole Vine Products
First posted: 2014-03-21
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Endothelial function as measured by reactive hyperemia EndoPAT scores
timeFrame: Baseline to 4 months
Secondary outcomes:
measure: Change in High Sensitive C-reactive protein (hsCRP)
timeFrame: Baseline to 4 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Amir Lerman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Corban MT, Widmer RJ, Cilluffo R, Kazeck MA, Lennon RJ, Lerman LO, Lerman A. The effect of polyphenol-rich chardonnay seed supplements on peripheral endothelial function. Eur J Nutr. 2020 Dec;59(8):3723-3734. doi: 10.1007/s00394-020-02203-6. Epub 2020 Feb 17.