Metabolic Response to Chardonnay Grape Marc Powder

NCT03203915 | Completed

• 1 other identifier: 81946-4
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dyslipidemia; Obesity

Keywords

cholesterol; triglyceride; grape seed extract; chardonnay marc powder; polyphenol; gut microbiome

Outcome Measures

Primary Outcomes (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)

  Weeks 4, 10, 16

Secondary Outcomes (6)

• Changes in fecal microbiome profile

  Weeks 1, 4, 10, 16

• Changes in gut fermentation profile

  Weeks 4, 10, 16

• Changes in inflammatory markers

  Weeks 4, 10, 16

• Changes in endothelial function measurement and blood pressure

  Weeks 4, 10, 16

• Changes in metabolomic profile

  Weeks 1, 4, 10, 16

Other Outcomes (8)

• Changes in glucose metabolism

  Weeks 4, 10, 16

• Changes in appetite hormones

  Weeks 4, 10, 16

• Changes in body composition and energy expenditure

  Weeks 4, 10, 16

Study Arms (6)

Group 1

EXPERIMENTAL

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

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 2

EXPERIMENTAL

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

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 3

EXPERIMENTAL

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

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 4

EXPERIMENTAL

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

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 5

EXPERIMENTAL

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

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 6

EXPERIMENTAL

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

Dietary Supplement: Chardonnay grape marc marc high polyphenol dose (120mg); Dietary Supplement: Chardonnay grape marc powder low polyphenol dose (75mg); Dietary Supplement: Placebo (0mg)

Interventions

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

Group 1; Group 2; Group 3; Group 4; Group 5; Group 6

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

Group 1; Group 2; Group 3; Group 4; Group 5; Group 6

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

Group 1; Group 2; Group 3; Group 4; Group 5; Group 6

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• USDA, Western Human Nutrition Research Center: lead
• Sonomaceuticals LLC: collaborator

Study Sites (1)

Western Human Nutrition Research Center

Davis, California, 95616, United States

Location

MeSH Terms

Conditions

Dyslipidemias; Obesity

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nancy L Keim, PhD

  United States Department of Agriculture (USDA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2017
• First Posted: June 29, 2017
• Study Start: August 1, 2017
• Primary Completion: June 28, 2019
• Study Completion: June 28, 2019
• Last Updated: July 16, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)