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Ambrosia: Evaluating the Effects of a Food-As-Medicine Platform on Gut Microbiome Composition and Metabolism

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Impact of Dietary Chages Directed by Medical Nutrition Therapy on Gut Microbiome Composition

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Ambrosia: Evaluating the Effects of a Food-As-Medicine Platform on Gut Microbiome Composition and Metabolism

Quick Facts

Study Start:2023-11-01
Study Completion:2025-03-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06091813

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 64 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Adults 18 to 64 years old at the time of enrollment at high risk for colorectal cancer, defined as follows:
  2. 1. EITHER a personal history of colorectal cancer, advanced adenoma, or 3 or more non-advanced adenomas in a single screening
  3. 2. OR TWO of the following criteria:
  4. * One or more first-degree relatives with a history of colorectal cancer
  5. * Body mass index above 30 (Persephone will calculate given height and weight
  6. * Have smoked an average of 5 or more cigarettes (1/4 pack) per day for a continuous period of 10 years or more.
  7. 2. Able to provide stool samples at study start and after approximately 5 months
  8. 3. Willing and able to undergo virtual Medical Nutrition Therapy based on cohort assignment
  9. 4. Willing to complete online questionnaires concerning diet and lifestyle, in English
  10. 5. Competency in spoken and written English
  11. 6. Can provide written informed consent
  1. 1. Subjects with known HIV, Hepatitis A, Hepatitis B, Hepatitis C
  2. 2. Known Familial Adenomatous Polyposis or Lynch Syndrome (aka Hereditary Non-Polyposis Colorectal Cancer or HNPCC) diagnosis
  3. 3. A history of Crohn's Disease, Inflammatory Bowel Disease, or chronic colitis.
  4. 4. Active cancer in the past 2 years, or currently undergoing any form of cancer therapy.
  5. 5. Confirmed case of COVID-19 or influenza within one month prior to enrollment
  6. 6. Oral or systemic antibiotic or probiotic use, or a known GI infection, within 3 months prior to enrollment
  7. 7. Engaged in a nutritional or dietary intervention in the past 3 months.
  8. 8. Women who are pregnant or plan to become pregnant in the next 6 months, or currently nursing.

Contacts and Locations

Principal Investigator

Charles Baum, MD
PRINCIPAL_INVESTIGATOR
Independent

Study Locations (Sites)

Persephone Biosciences, Inc.
San Diego, California, 92121
United States

Collaborators and Investigators

Sponsor: Persephone Biosciences

  • Charles Baum, MD, PRINCIPAL_INVESTIGATOR, Independent

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-01
Study Completion Date2025-03-15

Study Record Updates

Study Start Date2023-11-01
Study Completion Date2025-03-15

Terms related to this study

Additional Relevant MeSH Terms

  • Impact of Dietary Chages Directed by Medical Nutrition Therapy on Gut Microbiome Composition