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Clinical Trial Summary

The objective of this study is to test whether dietary behavior modification impacts diet quality and stool microbiome composition and metabolism using microbial whole genome sequencing, targeted metabolomics, and immune profiling. 400 adults 18-64 years old at high risk for CRC (based on past colonoscopy findings or lifestyle risk factors) will be assigned to one of two cohorts, with approximately 200 participants in each. - Cohort 1 will serve as the control group without any directed dietary modifications. - Cohort 2 participants will receive medical nutrition therapy (MNT) via 5 Telenutrition (TN) visits with a registered dietitian (RD), utilizing the Academy of Nutrition and Dietetics' Nutrition Care Process. Stool samples will be obtained for each subject at baseline and end of study. Whole genome sequencing, metabolite analysis, and immune profiling will be performed on the samples. Demographic data, general health information, diet and lifestyle information will be collected from the subjects (all self-reported). When applicable, notes from telenutrition appointments will also be collected. Diet information will be collected using the Picture Your Plate(TM) validated food questionnaire.


Clinical Trial Description

n/a


Study Design


NCT number NCT06091813
Study type Interventional
Source Persephone Biosciences
Contact Stephen Van Dien, PhD
Phone 858-682-4777
Email svandien@persephonebiome.com
Status Recruiting
Phase N/A
Start date November 1, 2023
Completion date September 30, 2024