Metabolic Response to Chardonnay Grape Marc Powder

Obesity Clinical Trial

Official title:

Metabolic Response to Chardonnay Grape Marc Powder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03203915
• Other study ID #: 81946-4
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: June 28, 2019

Study information

• Verified date: July 2021
• Source: USDA, Western Human Nutrition Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: June 28, 2019
• Est. primary completion date: June 28, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Obesity

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Western Human Nutrition Research Center	Davis	California

Sponsors (2)

Lead Sponsor	Collaborator
USDA, Western Human Nutrition Research Center	Sonomaceuticals LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	Changes in oxidized LDL	oxidized LDL measured at fasting and 1, 2, 3 hrs postprandial	Weeks 4, 10, 16
Other	Changes in apolipoprotein profile	Apo CIII, Apo B, Apo AI, Apo E measured at fasting and postprandial (1 and 3hr)	Weeks 4, 10, 16
Other	General health	General well being via questionnaire, comprehensive metabolic panel (at fasting), fatty liver index	Weeks 4, 10, 16
Primary	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	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
Secondary	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
Secondary	Changes in inflammatory markers	Immunological markers such as: tumor necrosis factor-a, Interleukin-ß, 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
Secondary	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
Secondary	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
Secondary	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