Ambrosia: Evaluating the Effects of a Food-As-Medicine Platform on Gut Microbiome Composition and… (NCT06091813) | Clinical Trial Compass
CompletedNot Applicable
Ambrosia: Evaluating the Effects of a Food-As-Medicine Platform on Gut Microbiome Composition and Metabolism
United States546 participantsStarted 2023-11-01
Plain-language 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.
Who can participate
Age range18 Years – 64 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Adults 18 to 64 years old at the time of enrollment at high risk for colorectal cancer, defined as follows:
✓. EITHER a personal history of colorectal cancer, advanced adenoma, or 3 or more non-advanced adenomas in a single screening
✓. OR TWO of the following criteria:
✓. Able to provide stool samples at study start and after approximately 5 months
✓. Willing and able to undergo virtual Medical Nutrition Therapy based on cohort assignment
✓. Willing to complete online questionnaires concerning diet and lifestyle, in English
✓. Competency in spoken and written English
✓. Can provide written informed consent
Exclusion criteria
✕. Subjects with known HIV, Hepatitis A, Hepatitis B, Hepatitis C
✕. Known Familial Adenomatous Polyposis or Lynch Syndrome (aka Hereditary Non-Polyposis Colorectal Cancer or HNPCC) diagnosis