NCT02093455

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

March 18, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 21, 2014

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2017

Completed
Last Updated

February 11, 2022

Status Verified

February 1, 2022

Enrollment Period

3.5 years

First QC Date

March 18, 2014

Last Update Submit

February 1, 2022

Conditions

1. Endothelial Dysfunction (EndoPAT Score <=2)

Keywords

Endothelial function

Outcome Measures

Primary Outcomes (1)

  • Endothelial function as measured by reactive hyperemia EndoPAT scores

    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.

    Baseline to 4 months

Secondary Outcomes (1)

  • Change in High Sensitive C-reactive protein (hsCRP)

    Baseline to 4 months

Study Arms (2)

Chardonnay Seed Flour (CSF)

ACTIVE COMPARATOR

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.

Dietary Supplement: Chardonnay Seed Flour (CSF)

Placebo

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo

Interventions

Chardonnay Seed Flour (CSF)DIETARY_SUPPLEMENT

CSF is made from wine grape skins and seeds.

Chardonnay Seed Flour (CSF)
PlaceboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • 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.

    PMID: 32067098DERIVED

Related Links

Study Officials

  • Amir Lerman, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

March 18, 2014

First Posted

March 21, 2014

Study Start

March 1, 2014

Primary Completion

August 23, 2017

Study Completion

August 23, 2017

Last Updated

February 11, 2022

Record last verified: 2022-02

Locations

US(1)