Response of Gut Microbiota and Cardiometabolic Biomarkers to Consumption of Walnuts

Withdrawn before enrolling · Not applicable

Conditions studied: Healthy, Normal Weight, Overweight, Obese

In brief

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 will be separated by a 4 week washout period. The order of diets will be random; study participants will complete both interventions. Dietary modifications will be part of the study protocol.

Key facts

Study ID

NCT04307628

Run by

University of California, Davis

People needed

0

Starts

2022-06-01

Expected to finish

2024-11-30

Last updated by the study team

2024-05-22

Who can join

Age: 20 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Ragle Human Nutrition Research Center — Davis, California, United States

Full record on ClinicalTrials.gov

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