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NCT06091813 · ClinicalTrials.gov registry record · NA
Ambrosia: Evaluating the Effects of a Food-As-Medicine Platform on Gut Microbiome Composition and Metabolism
A NA study, sponsored by Persephone Biosciences.
- Completed
- Registry status
- NA
- Development phase
- 546
- Enrollment target
NCT06091813: Completed NA study, sponsored by Persephone Biosciences.
NCT06091813 is a NA study that has completed, run by Persephone Biosciences. The registered enrollment target is 546 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06091813, a NA study, has completed, sponsored by Persephone Biosciences.
- COMPLETED
- Registry status
- NA
- Development phase
- 546 participants
- Enrollment target
Study 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.
Primary Outcome
Measure microbiome composition before and after 5 telenutrition visits by whole genome sequencing, and determine change in microbial composition as indicated by gUnifrac distance between the two datapoints.
Interventions
- BEHAVIORAL Nutrition Counseling
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 546 participants |
| Start Date | 2023-11-01 |
| Est. Completion | 2025-03-15 |
| Phase | NA |
What the finished NCT06091813 record still lists
NCT06091813 is an interventional study that assigns participants to a tested intervention. The registered 546 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (61% lower).
The record links to 0 conditions, and to 1 intervention - of which Nutrition Counseling is the first listed.
NCT06091813 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06091813 about?
NCT06091813 is a clinical study titled "Ambrosia: Evaluating the Effects of a Food-As-Medicine Platform on Gut Microbiome Composition and Metabolism". 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 colo...
What is the current status of trial NCT06091813?
This trial is currently completed. It is a NA study. The enrollment target is 546 participants. The study started on 2023-11-01. Estimated completion is 2025-03-15.
What interventions are being tested in trial NCT06091813?
The interventions under investigation include: Nutrition Counseling (BEHAVIORAL).
Who is sponsoring clinical trial NCT06091813?
This trial is sponsored by Persephone Biosciences, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06091813's enrollment target sits among peer trials
546 186th of 2000 higher than 1,815 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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