Metabolic Response to Chardonnay Grape Pomace Powder



Status:Active, not recruiting
Conditions:High Cholesterol, Obesity Weight Loss
Therapuetic Areas:Cardiology / Vascular Diseases, Endocrinology
Healthy:No
Age Range:35 - 65
Updated:3/3/2019
Start Date:August 1, 2017
End Date:August 2019

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

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 pomace 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 pomace 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 pomace
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
pomace 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.

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.
We found this trial at
1
site
Davis, California 95616
Principal Investigator: Nancy L Keim, PhD
Phone: 530-752-4184
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mi
from
Davis, CA
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