Who may be eligible for the Nutritional Ketosis Marfan trial?

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.

ClinicalTrials.gov record NCT07495267

Nutritional Ketosis Marfan

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 6, 2026

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

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.

Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.

Age18 years old to 50 years old

SexAll

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This pilot study will enroll 15 adults with Marfan syndrome who have a chronic aortic dissection. Participants will follow a supervised ketogenic diet for 12 months, monitor ketones at home, give periodic blood samples, and have CT scans of the aorta at baseline, 6 months, and 12 months while continuing usual medications. The main comparison is freedom from aortic intervention at 12 months against historical expectations; the study will also track diet adherence, aortic size changes, and blood inflammatory markers.

What it is studying. The study tests whether a carefully supervised ketogenic diet can be maintained for 12 months by adults with Marfan syndrome who have a chronic aortic dissection, and whether the diet is associated with freedom from aortic intervention at 12 months compared with historical controls. Investigators will also observe changes in aortic size and inflammatory markers and measure how well participants adhere to the diet.

What the researchers hope to learn. To determine freedom from aortic intervention at 12 months compared with historical controls; to measure diet adherence using home ketone monitoring; to observe changes in aortic dissection size and in blood inflammatory markers over 12 months.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Other: Ketogenic diet

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

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

Exclusion criteria

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

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Follow a supervised ketogenic diet for 12 months with regular guidance and check-ins from a study coordinator and dietitian. Measure ketone levels at home (finger-stick and saliva testing, several times per week) and relay readings to the study team; have blood samples every three months to confirm ketosis. Undergo standard-of-care CT scans of the aorta at baseline, 6 months, and 12 months. Continue usual heart and blood-pressure medicines and routine care with their own doctors while the study tracks diet adherence, aorta size, and blood inflammatory markers.

How the study is structured. Single-group interventional pilot study. About 15 participants follow a ketogenic diet (about 12 months) with regular support from study staff, home ketone monitoring (saliva and finger‑stick measurements several times per week), blood tests every three months to confirm ketosis, and standard CT scans of the aorta at start, 6 months, and 12 months. Participants continue their usual heart and blood-pressure medicines and regular medical care.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

The registry says recruitment has not started. When is it expected to open, and can I register interest now?
No sites are listed on the registry yet. Where will the study take place?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on Marfan syndrome

Clinical trials20 trials listed for Marfan syndromeEvery trial the registry lists for Marfan syndrome, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Marfan syndrome researchLatest monthly update: September 2026. Includes: After open aortic repair. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: Mar 13, 2026 (estimated)
Primary completion: Mar 1, 2028 (estimated)
Study completion: Mar 1, 2028 (estimated)
Target enrollment: 15 participants (estimated)
Last updated on registry: Mar 27, 2026
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: Washington University School of Medicine

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Mohamed Zayed, MD, PhD, MBA, DFSVS, FAHA, FAC 📞 (314) 362-5648 ✉ zayedm@wustl.edu
Kelly Koogler, RN, BSN 📞 3142861506 ✉ kooglerk@wustl.edu

Participating sites

Study locations have not been posted on ClinicalTrials.gov yet. This study is not yet recruiting, so sites may be added when recruitment begins. The central study contact above may be able to tell you about planned sites.

Terms used on this page · explanations by MedicalUpdates.ai

Standard of care: Treatment generally considered appropriate for a condition in a particular clinical setting. It can vary by patient, place and over time. In many studies the new treatment is added to, or compared with, standard of care.
computed tomography: An X-ray scan that builds detailed cross-section images of the body. 'High-resolution' CT (HRCT) is used to look closely at the lungs.
written informed consent: The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
baseline: Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
follow-up: The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
enrollment: The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
principal investigator: The doctor or scientist responsible for running the study at a site or overall.
Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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