Metabolic Response to Chardonnay Grape Marc Powder

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Dyslipidemia
• Intervention / Treatment: Dietary supplement: Chardonnay grape marc marc high polyphenol dose (120mg); Dietary supplement: Chardonnay grape marc powder low polyphenol dose (75mg); Dietary supplement: Placebo (0mg)

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.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Davis, California, United States, 95616
      • Western Human Nutrition Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 33 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; 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); 3 prepackaged capsules taken once in the morning with meal for 3 weeks. The total dose will be 120mg of total polyphenols; 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; 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
Experimental: Group 2; 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); 3 prepackaged capsules taken once in the morning with meal for 3 weeks. The total dose will be 120mg of total polyphenols; 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; 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
Experimental: Group 3; 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); 3 prepackaged capsules taken once in the morning with meal for 3 weeks. The total dose will be 120mg of total polyphenols; 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; 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
Experimental: Group 4; 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); 3 prepackaged capsules taken once in the morning with meal for 3 weeks. The total dose will be 120mg of total polyphenols; 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; 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
Experimental: Group 5; 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); 3 prepackaged capsules taken once in the morning with meal for 3 weeks. The total dose will be 120mg of total polyphenols; 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; 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
Experimental: Group 6; 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); 3 prepackaged capsules taken once in the morning with meal for 3 weeks. The total dose will be 120mg of total polyphenols; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in fecal microbiome profile	Gut microbiota community profile will be determined by 6M read metagenomic gene sequencing from stool samples	Weeks 1, 4, 10, 16
Changes in gut fermentation profile	Hydrogen and methane gas (parts per million) will be measured simultaneously in breath to assess gut fermentation	Weeks 4, 10, 16
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.	Weeks 4, 10, 16
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).	Weeks 4, 10, 16
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.	Weeks 1, 4, 10, 16
Changes in cognitive function	Executive function will be assessed using Cambridge Neuropsychological Test Automated Battery (CANTAB) and Autonomic Nervous System Output.	Weeks 4, 10, 16

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in glucose metabolism	Glucose and insulin measures at fasting and postprandially (1, 2, 3 hrs). this includes assessing insulin resistance and sensitivity indexes using fasting measurements.	Weeks 4, 10, 16
Changes in appetite hormones	Leptin, Ghrelin, Peptide YY 3-36, Glucagon-like peptide-1 at fasting and postprandial (1, 2, 3 hr)	Weeks 4, 10, 16
Changes in body composition and energy expenditure	Body composition by Dual energy X-ray Absorptiometry scan (radiologic exposure), body weight, waist and hip circumference, indirect calorimetry measured each visit.	Weeks 4, 10, 16
Changes in self-report of hunger and mood	Subjective rating measures using a visual analog scale at fasting and every 20 mins postprandially./	Weeks 4, 10, 16
Changes in NMR lipid particle profile	cholesterol species (e.g. VLDL, IDL, LDL, etc) identified and their particle sizes (e.g. small, medium, large) identified at fasting and 3hr postprandial	Weeks 4, 10, 16
Changes in oxidized LDL	oxidized LDL measured at fasting and 1, 2, 3 hrs postprandial	Weeks 4, 10, 16
Changes in apolipoprotein profile	Apo CIII, Apo B, Apo AI, Apo E measured at fasting and postprandial (1 and 3hr)	Weeks 4, 10, 16
General health	General well being via questionnaire, comprehensive metabolic panel (at fasting), fatty liver index	Weeks 4, 10, 16

Collaborators and Investigators

• Sponsor: USDA, Western Human Nutrition Research Center
• Collaborators: Sonomaceuticals LLC
• Investigators: Principal Investigator: Nancy L Keim, PhD, USDA ARS

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): June 28, 2019
• Study Completion (Actual): June 28, 2019

Study Registration Dates

• First Submitted: June 23, 2017
• First Submitted That Met QC Criteria: June 26, 2017
• First Posted (Actual): June 29, 2017

Study Record Updates

• Last Update Posted (Actual): July 16, 2021
• Last Update Submitted That Met QC Criteria: July 12, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: gut microbiome; cholesterol; polyphenol; triglyceride; grape seed extract; chardonnay marc powder
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias
• Other Study ID Numbers: 81946-4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No