Clinical trial NCT06476795: The Influence of Chardonnay Marc Intake on Gut and Cardiometabolic Health
Official title: The Influence of Chardonnay Marc Intake on Gut and Cardiometabolic Health
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Adiposity
Cardiometabolic Syndrome
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2024-06-26
Enrollment: 5
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: We will use a two-arm escalation design
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Postmenopausal female, with a cessation of menses for at least 2 years
* 45-70 years of age
* BMI 31- 49.9 kg/m2
* Fasting triglycerides \> 120 mg/dL
* Subject is willing and able to comply with the study protocols and procedures.

Exclusion Criteria:

* Self-reported use of daily anticoagulation agents including aspirin, NSAIDs
* Prescription medications and supplements, except for a 6 month stable dose of thyroid medications
* Vegan, Vegetarians, food faddists or those consuming a non-traditional diet
* Fruit consumption ≥ 3 cups/day
* Vegetable consumption ≥ 4 cups/day
* Coffee/tea ≥ 3 cups/day
* Dark chocolate ≥ 3 oz/day
* Self-reported restriction of physical activity due to a chronic health condition
* Self-reported chronic/routine high intensity exercise
* Blood pressure ≥ 140/90 mm Hg
* Self-reported renal or liver disease
* Self-reported heart disease, which includes cardiovascular events and stroke, diabetes
* Peripheral artery disease Raynaud's syndrome or disease
* Inability to properly place or wear the PAT probes or abnormal measurements on pre-screening PAT
* Self-reported cancer within past 5 years
* Self-reported gastrointestinal disorders, apart from appendix removal
* Unwillingness to stop any supplement use, including herbal, plant or botanical, fish oil, oil supplements six weeks prior to study enrollment.
* Indications of substance or alcohol abuse within the last 3 years
* All forms of smoking (e.g. vaping, cigarette, cannabis)
* Current enrollee in a clinical research study.

Primary outcomes:
measure: Microvascular function
timeFrame: 12 weeks
Secondary outcomes:
measure: Plasma Cholesterol
timeFrame: 12 weeks
measure: Cytokines
timeFrame: 12 weeks
measure: short chain fatty acids
timeFrame: 12 weeks
measure: plasma bile acids
timeFrame: 12 weeks
measure: blood glucose
timeFrame: 12 weeks
measure: Gene expression
timeFrame: 12 weeks
measure: insulin
timeFrame: 12 weeks
measure: zonulin
timeFrame: 12 weeks
measure: lipopolysaccharide binding protein
timeFrame: 12 weeks
measure: Metabolomics
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Davis
country: United States
facility: University of California, Davis
state: California
Study officials:
References: