Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Directed Dietary Intervention | No Intervention | Control group without any directed dietary modifications | |
| Medical Nutrition Therapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutrition Counseling | Behavioral | Dietitian-led nutrition coaching via 5 Telenutrition visits, utilizing the Academy of Nutrition and Dietetics' Nutrition Care Process. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Nutrition Counseling Microbiome Impact | 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. | 4 months |
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Charles Baum, MD | Independent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Persephone Biosciences, Inc. | San Diego | California | 92121 | United States |
Not provided
| Label | URL |
|---|---|
| Link to sign up for study | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided