Impact of Dietary Chages Directed by Medical Nutrition Therapy on Gut Microbiome CompositionNCT06091813
Ambrosia: Evaluating the Effects of a Food-As-Medicine Platform on Gut Microbiome Composition and Metabolism
A study testing Nutrition Counseling in people with Impact of Dietary Chages Directed by Medical Nutrition Therapy on Gut Microbiome Composition, run by Persephone Biosciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Impact of Dietary Chages Directed by Medical Nutrition Therapy on Gut Microbiome Composition
- What is being tested?
- Nutrition Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 546 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2023to 15 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
- 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.
Show all 11Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Persephone Biosciences, Inc.
San Diego, California, 92121
About this study
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.
Read more
- 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.
- Conditions
- Impact of Dietary Chages Directed by Medical Nutrition Therapy on Gut Microbiome Composition
- Being tested
- Nutrition Counseling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition CounselingBehavioural
Dietitian-led nutrition coaching via 5 Telenutrition visits, utilizing the Academy of Nutrition and Dietetics' Nutrition Care Process.
| Study group | Role | What they receive |
|---|---|---|
| No Directed Dietary Intervention | No intervention | Control group without any directed dietary modifications |
| Medical Nutrition Therapy | Experimental | Not described Receives: Behavioral: Nutrition Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start1 Nov 2023
- Primary completion15 Mar 2025
- Study completion15 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impact of Dietary Chages Directed by Medical Nutrition Therapy on Gut Microbiome CompositionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 546 participants (actual)
Sponsor and investigators
- Lead sponsor
- Persephone Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charles Baum, MD, Principal investigator, Independent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06091813
- Sponsor's protocol ID
- PB-2023-01
- Status last verified
- Jul 2025
- First submitted
- 13 Oct 2023
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambrosia: Evaluating the Effects of a Food-As-Medicine Platform on Gut Microbiome Composition and Metabolism
- ClinicalTrials.gov ID
- NCT06091813
- Acronym / sponsor ID
- PB-2023-01
- Conditions
- Impact of Dietary Chages Directed by Medical Nutrition Therapy on Gut Microbiome Composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 546 participants (actual)
- Lead sponsor
- Persephone BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 15 Mar 2025 (actual)
- Study completion
- 15 Mar 2025 (actual)
- First posted
- 19 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Directed Dietary Intervention | No intervention | –Control group without any directed dietary modifications |
| Medical Nutrition Therapy | Experimental | Behavioral: Nutrition Counseling |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Adults 18 to 64 years old at the time of enrollment at high risk for colorectal cancer, defined as follows:
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition CounselingDietitian-led nutrition coaching via 5 Telenutrition visits, utilizing the Academy of Nutrition and Dietetics' Nutrition Care Process. | Behavioural | Medical Nutrition Therapy |
Primary outcome
Nutrition Counseling Microbiome Impact
Time frame: 4 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Link to sign up for studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Baum, MD principal investigator
Independent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition Counseling in people with Impact of Dietary Chages Directed by Medical Nutrition Therapy on Gut Microbiome Composition, run by Persephone Biosciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutrition Counseling Microbiome Impact (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.