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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 is a NA study that has completed, run by Persephone Biosciences. The registered enrollment target is 546 participants.
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.
Interventions
- BEHAVIORAL Nutrition Counseling
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 546 participants |
| Start Date | 2023-11-01 |
| Est. Completion | 2025-03-15 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06091813
The ClinicalTrials.gov registry entry for NCT06091813 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 546 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Persephone Biosciences, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Nutrition Counseling is the first listed.
NCT06091813 reports 0 study locations.
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.
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