Nutritional Ketosis Marfan

March 22, 2026 updated by: Washington University School of Medicine

Nutritional Ketosis as a Novel Therapeutic Strategy to Stabilize Chronic Aortic Dissection in Marfan Syndrome

In this pilot clinical trial, the investigators will test whether a carefully supervised ketogenic diet can safely help people with Marfan syndrome who already have a chronic or residual aortic dissection. Fifteen participants will work with a study coordinator and dietitian to learn how to follow the diet and will have regular guidance and check-ins. The participants will measure their blood ketone levels at home with a simple finger-stick device and relay their readings to the research team. Every three months, blood samples will also be collected to confirm the body's level of ketosis.

Participants will continue their usual heart and blood-pressure medicines and regular visits with their doctors. Standard of care computed tomography (CT) scans of the aorta will be performed at the start of the study and then again at 6 and 12 months to see if the aorta changes in size.

The main goal is to see how many patients can avoid needing aortic surgery within one year, compared with what is normally expected from past studies. The investigators will also track how well patients follow the diet, how their aorta changes, and whether inflammation in their blood decreases.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mohamed Zayed, MD, PhD, MBA, DFSVS, FAHA, FAC
  • Phone Number: (314) 362-5648
  • Email: zayedm@wustl.edu

Study Contact Backup

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Adults between 18 and 50 years old.
  2. Ability to understand and willingness to sign an Institutional Review Board (IRB) approved written informed consent document.
  3. Genetically or clinically confirmed Marfan syndrome
  4. Chronic descending thoracic aortic dissection present for at least three months
  5. Maximal descending thoracic aortic diameter must measure between 4.0 and 5.0 cm at baseline on contrast-enhanced computed tomography angiography (CTA)
  6. Have been clinically stable and consistent antihypertensive regimen for at least four weeks

Exclusion Criteria:

  1. Acute or rapidly enlarging dissection (>0.5 cm increase over the preceding three months)
  2. Prior descending thoracic aortic repair or endograft placement
  3. Advanced renal or hepatic dysfunction
  4. Poorly controlled diabetes requiring insulin
  5. Active malignancy, pregnancy, or other metabolic or nutritional disorders that would contraindicate ketogenic therapy
  6. Body mass index below 18 kg/m²
  7. Inability to comply with dietary restrictions or follow-up imaging
  8. Current enrollment in another interventional study, which in the opinion of the principal investigator, may confound study results.
  9. Patients who, in the opinion of the principal investigator, are not suitable candidates for study participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prospective Cohort

Participants will initiate a supervised ketogenic diet formulated to provide approximately 70-75% of calories from fat, 20% from protein, and less than 10% from carbohydrates, consistent with protocols successfully used in therapeutic epilepsy trials but adapted for adult cardiovascular patients.

They will measure their blood ketone levels at home with a simple finger-stick device and relay their readings to the research team. Every three months, blood samples will also be collected to confirm the body's level of ketosis.

Participants will continue their usual heart and blood-pressure medicines and regular visits with their doctors. Standard of care computed tomography (CT) scans of the aorta will be performed at the start of the study and then again at 6 and 12 months to see if the aorta changes in size.
Other: Ketogenic diet
Participants will continue ketogenic diet for 12 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom from aortic intervention
Time Frame: 12 months
Freedom from aortic intervention at 12 months compared with historical controls.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aortic dissection and inflammatory markers
Time Frame: 12 months
Observation of changes related to aortic dissection and inflammatory markers
12 months
Number of Participants who Maintained Diet Adherence measured by Ketone Monitor
Time Frame: From day 1 to 12 months
In order to measure adherence, participants will use a handheld ketone meter (Keto-Mojo) to measure β-hydroxybutyrate levels three times per week via saliva as well as finger-stick blood testing.
From day 1 to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Estimated)

March 13, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

March 12, 2026

First Submitted That Met QC Criteria

March 22, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 22, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202510143

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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