1. Endothelial Dysfunction (EndoPAT Score <=2)NCT02093455
Effects of Chardonnay Seed Flour on Vascular Health
A study testing Chardonnay Seed Flour (CSF) in people with 1. Endothelial Dysfunction (EndoPAT Score <=2), run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- 1. Endothelial Dysfunction (EndoPAT Score <=2)
- What is being tested?
- Chardonnay Seed Flour (CSF)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to 23 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 18 years old
- Demonstrated endothelial dysfunction (EndoPAT score <= 2) at time of screening.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
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).
- Being tested
- Chardonnay Seed Flour (CSF), Placebo
- Keywords
- Endothelial function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chardonnay Seed Flour (CSF)Dietary supplement
CSF is made from wine grape skins and seeds.
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 4 months
Secondary outcomes (1)
Change in High Sensitive C-reactive protein (hsCRP)
Measured: Baseline to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2014 (estimated)
- Study startMar 2014
- Primary completion23 Aug 2017
- Study completion23 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 1. Endothelial Dysfunction (EndoPAT Score <=2)Studies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Whole Vine Products
- Responsible party
- Principal investigator, Amir Lerman, Mayo Clinic
- Investigators
- Amir Lerman, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02093455
- Sponsor's protocol ID
- 13-007023
- Status last verified
- Feb 2022
- First submitted
- 18 Mar 2014
- Last updated
- 11 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32067098
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Chardonnay Seed Flour on Vascular Health
- ClinicalTrials.gov ID
- NCT02093455
- Acronym / sponsor ID
- 13-007023
- Keywords
- Endothelial function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Whole Vine Products
- Study start
- Mar 2014
- Primary completion
- 23 Aug 2017 (actual)
- Study completion
- 23 Aug 2017 (actual)
- First posted
- 21 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chardonnay Seed Flour (CSF) | Active comparator | Dietary Supplement: 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. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPre-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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age >= 18 years old
- Demonstrated endothelial dysfunction (EndoPAT score <= 2) at time of screening.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chardonnay Seed Flour (CSF)CSF is made from wine grape skins and seeds. | Dietary supplement | Chardonnay Seed Flour (CSF) |
| Placebo | Dietary supplement | Placebo |
Primary outcome
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.
1 secondary outcome
Change in High Sensitive C-reactive protein (hsCRP)
Time frame: Baseline to 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2022.
- Derived from this study: PubMed 32067098Corban 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.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amir Lerman, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chardonnay Seed Flour (CSF) in people with 1. Endothelial Dysfunction (EndoPAT Score <=2), run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial function as measured by reactive hyperemia EndoPAT scores (time frame: Baseline to 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02093455, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2022.