NCT04307628

Response of Gut Microbiota and Cardiometabolic Biomarkers to Consumption of Walnuts

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of California, Davis · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Accepted

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 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.

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 acids and secondary bile acids). The researchers hypothesize that walnut consumption will result in improvements to blood lipid profiles, including decreased total and LDL-cholesterol; increased HDL-related cholesterol efflux capacity and antioxidant protection; and decreased inflammatory biomarkers relative to control diet. The researchers hypothesize changes in cardiometabolic health biomarkers will be correlated with food bioactive metabolites and/or fecal metagenome. Pathway analysis will identify metabolic pathways differentially regulated by walnut-derived bioactives and walnut-responsive microbial genes.

Conditions

• Healthy
• Normal Weight
• Overweight
• Obese

Interventions

Type	Name	Description
OTHER	Walnut	Study participants will eat 2 ounces of walnuts each day.
OTHER	Nut-Free	Study participants will not eat nuts.

Timeline

• Start date: 2022-06-01
• Primary completion: 2024-06-30
• Completion: 2024-11-30
• First posted: 2020-03-13
• Last updated: 2024-05-22

Locations

1 site across 1 country: United States