Metabolic Response to Chardonnay Grape Marc Powder

NCT ID: NCT03203915

Last Updated: 2021-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2019-06-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Dyslipidemia Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group 1

Order of treatments:

A: Chardonnay grape marc powder high polyphenol dose B: Chardonnay grape marc powder low polyphenol dose C: Placebo

Group Type EXPERIMENTAL

Chardonnay grape marc marc high polyphenol dose (120mg)

Intervention Type 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)

Intervention Type 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)

Intervention Type DIETARY_SUPPLEMENT

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

Group 2

Order of treatments:

A: Chardonnay grape marc powder high polyphenol dose C: Placebo B: Chardonnay grape marc powder low polyphenol dose

Group Type EXPERIMENTAL

Chardonnay grape marc marc high polyphenol dose (120mg)

Intervention Type 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)

Intervention Type 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)

Intervention Type DIETARY_SUPPLEMENT

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

Group 3

Order of treatments:

B: Chardonnay grape marc powder low polyphenol dose C: Placebo A: Chardonnay grape marc powder high polyphenol dose

Group Type EXPERIMENTAL

Chardonnay grape marc marc high polyphenol dose (120mg)

Intervention Type 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)

Intervention Type 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)

Intervention Type DIETARY_SUPPLEMENT

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

Group 4

Order of treatments:

B: Chardonnay grape marc powder low polyphenol dose A: Chardonnay grape marc powder high polyphenol dose C: Placebo

Group Type EXPERIMENTAL

Chardonnay grape marc marc high polyphenol dose (120mg)

Intervention Type 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)

Intervention Type 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)

Intervention Type DIETARY_SUPPLEMENT

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

Group 5

Order of treatments:

C: Placebo A: Chardonnay grape marc powder high polyphenol dose B: Chardonnay grape marc powder low polyphenol dose

Group Type EXPERIMENTAL

Chardonnay grape marc marc high polyphenol dose (120mg)

Intervention Type 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)

Intervention Type 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)

Intervention Type DIETARY_SUPPLEMENT

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

Group 6

Order of treatments:

C: Placebo B: Chardonnay grape marc powder low polyphenol dose A: Chardonnay grape marc powder high polyphenol dose

Group Type EXPERIMENTAL

Chardonnay grape marc marc high polyphenol dose (120mg)

Intervention Type 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)

Intervention Type 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)

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Chardonnay grape marc marc high polyphenol dose (120mg)

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

Intervention Type DIETARY_SUPPLEMENT

Chardonnay grape marc powder low polyphenol dose (75mg)

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

Intervention Type DIETARY_SUPPLEMENT

Placebo (0mg)

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* 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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sonomaceuticals LLC

UNKNOWN

Sponsor Role collaborator

USDA, Western Human Nutrition Research Center

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nancy L Keim, PhD

Role: PRINCIPAL_INVESTIGATOR

United States Department of Agriculture (USDA)

Locations

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Western Human Nutrition Research Center

Davis, California, United States

Site Status

Countries

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United States

Other Identifiers

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81946-4

Identifier Type: -

Identifier Source: org_study_id

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