Status:
WITHDRAWN
Response of Gut Microbiota and Cardiometabolic Biomarkers to Consumption of Walnuts
Lead Sponsor:
University of California, Davis
Conditions:
Healthy
Normal Weight
Eligibility:
All Genders
20-65 years
Phase:
NA
Brief Summary
The researchers will investigate blood and fecal responses in qualified study participants after eating walnuts for 4 weeks compared to not eating walnuts for 4 weeks. The two dietary interventions wi...
Detailed Description
The researchers hypothesize that walnut consumption will induce changes in fecal metagenome, identifiable walnut-derived bioactives (urolithins) and other microbial-derived products (short-chain fatty...
Eligibility Criteria
Inclusion
- Generally healthy men and women between 20-65 years of age and BMI range of 20.0-34.9 kg/m2 will be recruited from the Davis - Sacramento metropolitan area. Enrolled subjects must be willing to consume 2 ounces (approximately 1/2 cup) of walnuts daily and modify their diet to avoid eating walnuts and other nuts, and foods or beverages high in polyphenols (a list will be provided) during study enrollment . 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. Screening will take place by phone interview and through in-person screening and consent, including anthropometric and biochemical assessments and health history questionnaires.
Exclusion
- 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; vegan diet.
- 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 (e.g. hormonal birth control)
- Poor venous access
- Unwillingness to comply with study protocols
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04307628
Start Date
June 1 2022
End Date
November 30 2024
Last Update
May 22 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Ragle Human Nutrition Research Center
Davis, California, United States, 95616