University of California, Davis
Davis, California, 95616, United States
Location status: Recruiting
NCT Number: NCT06476795
Recently a dietary recommendation of 400 - 600 mg/ day has been proposed for the reduced risk of developing cardiovascular disease. Dietary flavanols can be obtained from the intake of foods such as tea, cocoa, wine, berries and apples. Incorporating Chardonnay Marc (the skins and seeds of Chardonnay grapes) into the diet can be an additional source of dietary flavanols. Like other flavanol-rich foods, Chardonnay Marc provides fiber and polysaccharides that may benefit gut health. This study seeks pilot data on the impact of the daily incorporation of Chardonnay Marc powder into the diet on markers of gut and cardiometabolic health.
Interested in participating?
Request Info45 year–70 year
Female
Interventional
Not applicable
Davis, California, 95616, United States
Location status: Recruiting
The overall study objective is to obtain data on the impact of the dietary incorporation of Chardonnay marc on measures of gut and cardiometabolic health. Towards this goal, an escalation design will be employed to examine the effects of 6 - 12 weeks of daily Chardonnay marc intake on markers of gut permeability, inflammation and cardiometabolic health in obese individuals. Study procedures will be performed during 3 study visits conducted at baseline, and after 6 and 12 weeks of Chardonnay Marc intake. For each study visit, 50 ml of blood (~3.5 tbsp) will be collected. For the first six weeks of the study, the participants will be asked to incorporate 1.5 g of Chardonnay Marc into their diet between the hours of 11 am and 4 pm every day. This level of intake will be increased to 4.5 g of Chardonnay marc everyday from weeks 6-12. Therefore, all individuals will consume Chardonnay marc for at least 12 weeks. The participants will be instructed to not cook or add the Chardonnay Marc to hot foods, however, they will be allowed to add the Marc to tepid or warm foods and beverages. They will also be asked to log their intake and how they incorporated the Marc into their diet via a log.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Food product made from Chardonnay wine grapes
Time frame: 12 weeks
Microvascular function measured by peripheral arterial tonometry
Time frame: 12 weeks
Circulating levels of plasma lipids
Time frame: 12 weeks
Pro-inflammatory Th17 cytokines
Time frame: 12 weeks
Plasma and fecal levels of short chain fatty acids
Time frame: 12 weeks
Circulating levels of primary and secondary bile acids
Time frame: 12 weeks
fasting levels of blood glucose
Time frame: 12 weeks
gene expression from whole blood
Time frame: 12 weeks
plasma insulin levels after an overnight fast
Time frame: 12 weeks
serum and fecal zonulin as a measure of gut permeability
Time frame: 12 weeks
serum measure of gut permeability
Time frame: 12 weeks
plasma levels of untargeted metabolites
Contact information is provided by the study sponsor or research team.
University of California, Davis
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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