NCT06091813

Completed

Ambrosia: Evaluating the Effects of a Food-As-Medicine Platf...

Persephone Biosciences Source

Compare

Other study identifiers

Sponsor study identifier

PB-2023-01

Study Type

interventional

Actual enrollment (reported)

546

Locations

1 country

Sites

1

Timeline

Study Start

November 1, 2023

Actual (reported)

Primary Completion

March 15, 2025

Actual (reported)

Study Completion

March 15, 2025

Actual (reported)

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 Plate(TM) validated food questionnaire.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 546 participants
Study completion date: March 15, 2025
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
October 13, 2023
Actual (reported)
First Posted
October 19, 2023
Actual (reported)
Study Start
November 1, 2023
Actual (reported)
Primary Completion
March 15, 2025
Actual (reported)
Study Completion
March 15, 2025
Actual (reported)

Last Updated: July 31, 2025
Status Verified: July 2025
Last Update Submitted: July 28, 2025

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

Study Arms (2)

No Directed Dietary Intervention

NO INTERVENTION

Control group without any directed dietary modifications

Medical Nutrition Therapy

EXPERIMENTAL

Behavioral: Nutrition Counseling

Interventions

Nutrition CounselingBehavioral

Dietitian-led nutrition coaching via 5 Telenutrition visits, utilizing the Academy of Nutrition and Dietetics' Nutrition Care Process.

Medical Nutrition Therapy

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 64 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

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

Sponsors & Collaborators

Persephone Biosciences
Industrylead

Study Sites (1)

Persephone Biosciences, Inc.

San Diego, California, 92121, United States

Study Officials

Charles Baum, MD
Independent
PRINCIPAL INVESTIGATOR

Enrollment

546 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: BASIC SCIENCE
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 13, 2023

First Posted

October 19, 2023

Study Start

November 1, 2023

Actual (reported)

NCT06423963

Remote Exercise and Nutritional Prehabilitation for Pancreatic Cancer

Not ApplicableRecruiting

NCT05438940

Support Through Remote Observation and Nutrition Guidance (STRONG) Program for Gastroesophageal Cancer (GEC) Patients

Not ApplicableCompleted

NCT05802381

the Safety and Effectiveness of Protein Supplements on Cancer Patients With Nutritional Risk and Malnutrition

Not ApplicableUnknown

NCT05566197

Nusantara Diet (Low Calorie and Low Sodium) for Metabolic Syndrome

Not ApplicableUnknown

NCT01899001

Mood and Nutrition Interventions in Polycystic Ovary Syndrome

Not ApplicableCompleted

NCT04982640

Feasibility of Yoga for Type-2 Diabetes

Not ApplicableCompleted

OR TWO of the following criteria:

One or more first-degree relatives with a history of colorectal cancer

Body mass index above 30 (Persephone will calculate given height and weight

Have smoked an average of 5 or more cigarettes (1/4 pack) per day for a continuous period of 10 years or more.

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

You may not qualify if:

Subjects with known HIV, Hepatitis A, Hepatitis B, Hepatitis C
Known Familial Adenomatous Polyposis or Lynch Syndrome (aka Hereditary Non-Polyposis Colorectal Cancer or HNPCC) diagnosis
A history of Crohn's Disease, Inflammatory Bowel Disease, or chronic colitis.
Active cancer in the past 2 years, or currently undergoing any form of cancer therapy.
Confirmed case of COVID-19 or influenza within one month prior to enrollment
Oral or systemic antibiotic or probiotic use, or a known GI infection, within 3 months prior to enrollment
Engaged in a nutritional or dietary intervention in the past 3 months.
Women who are pregnant or plan to become pregnant in the next 6 months, or currently nursing.

Contact the study team to confirm eligibility.

Primary Completion

March 15, 2025

Actual (reported)

Study Completion

March 15, 2025

Actual (reported)

Last Updated

July 31, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT06091813
Data provider: ClinicalTrials.gov
Source updated: 2025-07-31
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:21:34 UTC

Locations

US(1)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

No Directed Dietary Intervention

Medical Nutrition Therapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

No Directed Dietary Intervention

Medical Nutrition Therapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations