Ignite Creation Date:
2024-05-06 @ 7:41 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06091813
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2023-10-13
Brief Title:
Ambrosia Evaluating the Effects of a Food-As-Medicine Platform on Gut Microbiome Composition and Metabolism
Sponsor:
Persephone Biosciences
Organization:
Persephone Biosciences
Study Overview
Official Title:
Ambrosia Evaluating the Effects of a Food-As-Medicine Platform on Gut Microbiome Composition and Metabolism
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 PlateTM validated food questionnaire
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 PlateTM validated food questionnaire
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None