Status:
ACTIVE_NOT_RECRUITING
Response of Cardiometabolic Biomarkers and Gut Microbiota to Walnut Consumption
Lead Sponsor:
University of California, Davis
Conditions:
Cardiovascular Diseases
Eligibility:
All Genders
45-70 years
Phase:
NA
Brief Summary
The purpose of this research is to test if eating walnuts will cause any changes in blood lipids (like good and bad cholesterol, for example) and levels of inflammation in the blood, as well as change...
Detailed Description
The purpose of this research is to test if eating walnuts will cause any changes in blood lipids (like good and bad cholesterol, for example) and levels of inflammation in the blood, as well as change...
Eligibility Criteria
Inclusion
- Overweight and obese men and postmenopausal women between 45-70 years of age, BMI range of 25.0-39.9 kg/m2 and elevated LDL-C levels (130-189 mg/dL).
Exclusion
- Adults unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant or lactating women, women planning to become pregnant in the next four months and prisoners will be specifically excluded.
- Additional exclusion criteria are listed below:
- Allergy to walnuts or other nuts
- Eating more than 25 grams of fiber per day, assessed by the Block Dietary-Fruit-Vegetable-Fiber Screener©
- Taking medications or supplements known to affect metabolism or gut microbiota composition (i.e. Metformin, statins, antibiotics within the past 3 months, fiber supplements, probiotics, and others)
- Documented chronic diseases including diabetes, renal or liver disease, metabolic syndrome, active cancer, MI or stroke, history of gastric bypass or GI disease (e.g. Crohn's Disease, Irritable Bowel Disease, diverticulosis, diverticulitis, etc.)
- Smoker or living with a smoker, including vaporizer and/or electronic cigarettes.
- Illicit drug use, cannabis usage, or consuming \>1 alcoholic drink/day
- Extreme dietary or exercise patterns
- Recent weight fluctuations (\>10% in the last 6 months)
- Taking prescription lipid medications or supplements that may affect lipoprotein metabolism (i.e. \>1 g of fish oil/day, antioxidant supplements)
- Taking exogenous hormones
- Poor venous access
- Unwillingness to comply with study protocols
Key Trial Info
Start Date :
April 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05321277
Start Date
April 19 2022
End Date
August 1 2025
Last Update
April 2 2025
Active Locations (1)
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1
Ragle Human Nutrition Center
Davis, California, United States, 95616