AzTrials
AzTrials

DyslipidemiaNCT03203915

Metabolic Response to Chardonnay Grape Marc Powder

A study testing Chardonnay grape marc marc high polyphenol dose (120mg) and Chardonnay grape marc powder low polyphenol dose (75mg) in people with Dyslipidemia and Obesity, run by USDA, Western Human Nutrition Research Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

To determine if the addition of chardonnay grape marc (also called pomace) powder enriched with grape seed extract to the diet will result in reducing blood levels of cholesterol or triglycerides. Read more about this study

Who is it for?
Ages 35 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Dyslipidemia, Obesity
What is being tested?
Chardonnay grape marc marc high polyphenol dose (120mg) and Chardonnay grape marc powder low polyphenol dose (75mg)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
31 participants
Where
1 siteUnited States
Study dates
1 Aug 2017to 28 Jun 2019
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 35 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • BMI ≥ 25 and < 40 kg/m2
  • Dyslipidemia as defined as (any one or all of the following values):
  • Total cholesterol > 190 mg/dL but < 240 mg/dL
  • LDL-cholesterol > 130 mg/dL but < 160 mg/dL
  • HDL-cholesterol < 40 mg/dL (men)/<50 mg/dL (women)
  • Fasting triglycerides > 150 mg/dL but < 300 mg/dL

Who cannot join

  • Renal, cardiovascular, gastrointestinal or hepatic disease, by medical history
  • History of a previous cardiovascular event
  • Diagnosis of type 2 diabetes
  • Pregnancy or lactation
  • Use of tobacco
  • Food sensitivities or allergies to the foods or components of foods provided in the standard meals including gluten, dairy, egg, soy, nuts, or seafood
Show all 9Show fewer
  • Use of herbal or plant-based supplements; omega-3 fatty acids, and fish oils in the past 3-6 months, and unwilling to discontinue use while participating in the study.
  • Use of lipid-lowering, glucose-lowering, anti-hypertensive, or weight loss medications
  • Use of antibiotics in the last three months.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Western Human Nutrition Research Center

    Davis, California, 95616

Other trials in United States

About this study

To determine if the addition of chardonnay grape marc (also called pomace) powder enriched with grape seed extract to the diet will result in reducing blood levels of cholesterol or triglycerides.

Read the detailed description

Previous research on grape seed nutritional properties has predominantly been confined to grape seed extracts (GSE) containing only soluble components. In animal models, GSE has been shown to prevent increases in blood pressure, blood cholesterol, and insulin resistance. In humans, there have been improvements in blood pressure, however no significant effect on blood cholesterol levels. Whole milled grape marc flours deliver more dietary complexity than seed extracts alone. In addition to the extractable and non-extractable polyphenols, flour offers dietary fiber, minerals, sterols and polyunsaturated fats. Grape marc flour is currently used as a food ingredient that is incorporated into various baked goods. However, to obtain good control of the dose level, the product will be provided in capsule form for this study. For reference, a ½ cup of of a high polyphenol food such as blueberries, contains about 325 milligrams of polyphenols, thus even with the higher dose, participants will be receiving an amount of polyphenols that is less than ¼ cup of blueberries. The grape marc powder is prepared in a facility that is certified for producing food-grade products, and the nutritional composition and safety of the product will be thoroughly evaluated before we begin the study. The objective of the current study is to determine if this chardonnay grape marc powder enriched with grape seed extract supplementation has beneficial impacts on the human blood lipid profile and to correlate gut biome changes to human metabolism.

Being tested
Chardonnay grape marc marc high polyphenol dose (120mg), Chardonnay grape marc powder low polyphenol dose (75mg), Placebo (0mg)
Keywords
cholesterol, triglyceride, grape seed extract, chardonnay marc powder, polyphenol, gut microbiome
Medical subject headings
Dyslipidemias, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chardonnay grape marc marc high polyphenol dose (120mg)Dietary supplement

    3 prepackaged capsules taken once in the morning with meal for 3 weeks. The total dose will be 120mg of total polyphenols

  • Chardonnay grape marc powder low polyphenol dose (75mg)Dietary supplement

    3 prepackaged capsules taken once in the morning with meal for 3 weeks. The total dose will be 75mg of total polyphenols

  • Placebo (0mg)Dietary supplement

    3 prepackaged capsules taken once in the morning with meal for 3 weeks. The total dose will be 0mg of polyphenols

Study groups in NCT03203915
Study groupRoleWhat they receive
Group 1ExperimentalOrder of treatments: A: Chardonnay grape marc powder high polyphenol dose B: Chardonnay grape marc powder low polyphenol dose C: Placebo
Receives: Dietary Supplement: Chardonnay grape marc marc high polyphenol dose (120mg); Dietary Supplement: Chardonnay grape marc powder low polyphenol dose (75mg); Dietary Supplement: Placebo (0mg)
Group 2ExperimentalOrder of treatments: A: Chardonnay grape marc powder high polyphenol dose C: Placebo B: Chardonnay grape marc powder low polyphenol dose
Receives: Dietary Supplement: Chardonnay grape marc marc high polyphenol dose (120mg); Dietary Supplement: Chardonnay grape marc powder low polyphenol dose (75mg); Dietary Supplement: Placebo (0mg)
Group 3ExperimentalOrder of treatments: B: Chardonnay grape marc powder low polyphenol dose C: Placebo A: Chardonnay grape marc powder high polyphenol dose
Receives: Dietary Supplement: Chardonnay grape marc marc high polyphenol dose (120mg); Dietary Supplement: Chardonnay grape marc powder low polyphenol dose (75mg); Dietary Supplement: Placebo (0mg)
Group 4ExperimentalOrder of treatments: B: Chardonnay grape marc powder low polyphenol dose A: Chardonnay grape marc powder high polyphenol dose C: Placebo
Receives: Dietary Supplement: Chardonnay grape marc marc high polyphenol dose (120mg); Dietary Supplement: Chardonnay grape marc powder low polyphenol dose (75mg); Dietary Supplement: Placebo (0mg)
Group 5ExperimentalOrder of treatments: C: Placebo A: Chardonnay grape marc powder high polyphenol dose B: Chardonnay grape marc powder low polyphenol dose
Receives: Dietary Supplement: Chardonnay grape marc marc high polyphenol dose (120mg); Dietary Supplement: Chardonnay grape marc powder low polyphenol dose (75mg); Dietary Supplement: Placebo (0mg)
Group 6ExperimentalOrder of treatments: C: Placebo B: Chardonnay grape marc powder low polyphenol dose A: Chardonnay grape marc powder high polyphenol dose
Receives: Dietary Supplement: Chardonnay grape marc marc high polyphenol dose (120mg); Dietary Supplement: Chardonnay grape marc powder low polyphenol dose (75mg); Dietary Supplement: Placebo (0mg)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in lipid profile

    Fasting triglyceride concentrations, LDL cholesterol, HDL cholesterol, non-HDL cholesterol will be measured in serum; postprandial triglyceride measurements (1, 2, 3 hours)

    Measured: Weeks 4, 10, 16

Secondary outcomes (6)

  1. Changes in fecal microbiome profile

    Gut microbiota community profile will be determined by 6M read metagenomic gene sequencing from stool samples

    Measured: Weeks 1, 4, 10, 16

  2. Changes in gut fermentation profile

    Hydrogen and methane gas (parts per million) will be measured simultaneously in breath to assess gut fermentation

    Measured: Weeks 4, 10, 16

  3. Changes in inflammatory markers

    Immunological markers such as: tumor necrosis factor-α, Interleukin-β, Interleukin-6, Interleukin-1B, Interleukin-10, Interleukin-18, Interleukin-1a, Intercellular Adhesion Molecule 1, vascular cell adhesion molecule 1, C-reactive protein, Serum amyloid A, neopterin, myeloperoxidase, eotaxin, Interferon gamma-induced protein 10, Myeloid dendritic cell, monocyte chemoattractant protein 1, Matrix metalloproteinase-1, Matrix metalloproteinase-3, Matrix metalloproteinase-9 will be taken at fasting at each test day.

    Measured: Weeks 4, 10, 16

  4. Changes in endothelial function measurement and blood pressure

    Blood pressure will be measured each test day. Endothelial function will be measured once per day using peripheral arterial tone (PAT) signal technology. Endothelial function is expressed as a Reactive Hyperemia Index (RHI).

    Measured: Weeks 4, 10, 16

  5. Changes in metabolomic profile

    Fecal bile acids, plasma bile acids, fecal and plasma short-chain fatty acids

    Fecal samples were taken at baseline and after each test day. Plasma samples were taken at fasting, 1, 2, and 3hrs postprandially.

    Measured: Weeks 1, 4, 10, 16

  6. Changes in cognitive function

    Executive function will be assessed using Cambridge Neuropsychological Test Automated Battery (CANTAB) and Autonomic Nervous System Output.

    Measured: Weeks 4, 10, 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2017
  2. Study start1 Aug 2017
  3. Primary completion28 Jun 2019
  4. Study completion28 Jun 2019

Resources

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
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03203915
Sponsor's protocol ID
81946-4
Status last verified
Jul 2021
First submitted
23 Jun 2017
Last updated
16 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lee F, Arvik T, Newman JW, Keim NL. Chardonnay grape marc/grape seed extract blends improve postprandial triglycerides and/or HDL cholesterol concentrations in adults with mild dyslipidemia in a randomized double blinded crossover trial. Nutr Res. 2026 May;149:66-80. doi: 10.1016/j.nutres.2026.02.009. Epub 2026 Mar 4.

    PubMed 41894982

Questions about this trial

What is this clinical trial studying?

A study testing Chardonnay grape marc marc high polyphenol dose (120mg) and Chardonnay grape marc powder low polyphenol dose (75mg) in people with Dyslipidemia and Obesity, run by USDA, Western Human Nutrition Research Center 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 6 inclusion and 9 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 16 Jul 2021. 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. 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?

Changes in lipid profile (time frame: Weeks 4, 10, 16). 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 NCT03203915, 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 16 Jul 2021; AzTrials last refreshed its copy on 2 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in