Summary

Eligibility
for females ages 45-70 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UC Davis
Dates
study started
completion around

Description

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. We seek pilot data on the impact of the daily incorporation of Chardonnay Marc powder into the diet on markers of gut and cardiometabolic health.

Details

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, we will use an escalation design that will allow us 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. We will instruct the participants 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. We will also ask them to log their intake and how they incorporated the Marc into their diet via a log.

Keywords

Cardiovascular Diseases, Adiposity, Cardiometabolic Syndrome, Metabolic Syndrome, Chardonnay Marc

Eligibility

You can join if…

Open to females ages 45-70

  • 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.

You CAN'T join if...

  • 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.

Location

  • University of California, Davis accepting new patients
    Davis California 95616 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Davis
ID
NCT06476795
Study Type
Interventional
Participants
Expecting 5 study participants
Last Updated