Trials / Completed
CompletedNCT06091813
Ambrosia: Evaluating the Effects of a Food-As-Medicine Platform on Gut Microbiome Composition and Metabolism
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 546 (actual)
- Sponsor
- Persephone Biosciences · Industry
- Sex
- All
- Age
- 18 Years – 64 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Nutrition Counseling | Dietitian-led nutrition coaching via 5 Telenutrition visits, utilizing the Academy of Nutrition and Dietetics' Nutrition Care Process. |
Timeline
- Start date
- 2023-11-01
- Primary completion
- 2025-03-15
- Completion
- 2025-03-15
- First posted
- 2023-10-19
- Last updated
- 2025-07-31
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT06091813. Inclusion in this directory is not an endorsement.