Study Results
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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COMPLETED
NA
31 participants
INTERVENTIONAL
2017-08-01
2019-06-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
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
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
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
Placebo (0mg)
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
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
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
Placebo (0mg)
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
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
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
Placebo (0mg)
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
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
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
Placebo (0mg)
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
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
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
Placebo (0mg)
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
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
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
Placebo (0mg)
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
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
Placebo (0mg)
3 prepackaged capsules taken once in the morning with meal for 3 weeks. The total dose will be 0mg of polyphenols
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
35 Years
65 Years
ALL
Yes
Sponsors
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Sonomaceuticals LLC
UNKNOWN
USDA, Western Human Nutrition Research Center
FED
Responsible Party
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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
Countries
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Other Identifiers
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81946-4
Identifier Type: -
Identifier Source: org_study_id
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