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Dietary Study for Clonal Hematopoiesis

This study is looking at whether a high-fiber plant-based diet (HFPBD) can improve your quality of life if you have clonal hematopoiesis (CH). CH is a condition where some of your blood stem cells have genetic changes. The study will provide you with 12 frozen prepared high-fiber plant-based meals per week and encourage fermented foods. You'll also be recommended to take a weekly vitamin B12 supplement. To join, you must have confirmed CH through genetic testing of your blood or bone marrow. The researchers will measure success by comparing improvements in your quality of life, which will be assessed using surveys over 12 weeks. The current recruitment status is unclear, and the study plans to enroll 36 people.

Study design
This is an interventional study, meaning you will receive a specific intervention. It plans to enroll 36 participants.
What's involved
You will receive 12 frozen prepared meals weekly and be encouraged to eat fermented foods. You will also be recommended to take a weekly vitamin B12 supplement and complete surveys to measure your quality of life.
Compensation
Not stated in the trial record.
Follow-up
Your quality of life will be measured for up to 12 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07590804

A Dietary Study for People With Clonal Hematopoiesis

Recruiting
NAAges 18+InterventionalPrevention
Memorial Sloan Kettering Cancer Center
~36 participants
Updated 2026-05-15 on ClinicalTrials.gov
What's tested:high-fiber plant-based mealsfermented foodssupplementssurveys

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
compare the rates of improvement in Quality Of Life
Measured over up to 12 weeks

Conditions

Clonal Hematopoiesis

Explore related trials

Clonal Cytopenia of Undetermined SignificanceClonal HematopoiesisSomatic Variation

Where it's being run

7 sites across 2 states
New York4
New Jersey3

Study leadership

  • Urvi Shah, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Urvi Shah, MD
[email protected]
646-608-3713
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

Patients must have confirmed clonal hematopoiesis via next generation sequencing (NGS) of blood or bone marrow biopsy sample
Patients with clonal cytopenias of undetermined significance (CCUS) are eligible if a bone marrow biopsy is done to exclude other causes.
Variant allele frequency must be ≥2% for mutation as measured by (NGS)
Treatment at MSK or at sites listed below that uses EPIC for electronic medical records and willing to share records with MSK through EPIC's care everywhere or through MSK's shared care network. If not meeting this criterion, decision to allow for participation is per PI discretion.
Age ≥ 18 years
BMI ≥25 kg/m\^2
Participant or caregiver must be able to complete surveys and have interest in trying new recipes or cooking.
Screening 24-hour dietary recall must consume \<30 grams dietary fiber per day to be eligible (any one of two 24-hour screening dietary recalls).
For patients at MSK, require bone marrow biopsy at screening in the past 24 weeks with collection of research biobanking sample. Bone marrow at other sites is optional.

Exclusion

Prior MDS/AML directed therapy
Chemotherapy, radiation, or immunotherapy within the past year (surgical- resection only or other cancer/precancer on observation is eligible)
Patients with a concurrent malignancy whose natural history or treatment may compromise completion of this trial are excluded.
Concurrent pregnancy will make a participant ineligible to participate
Patients that already follow a minimally processed (whole food) plant-based diet in the last 3 months are not eligible (ovo-lacto-vegetarian or processed junk food vegan diets are eligible).
Patients on GLP-1 drugs are eligible if it has been started at least 3 months prior to study and on stable dose. If it has been started more recently for diabetes mellitus control but not weight loss they are eligible. If it is medically indicated and started for diabetes mellitus control while on trial they will not be removed/excluded from trial.
Mental impairment leading to inability to cooperate will lead to exclusion from trial participation.
If in the opinion of the investigator there maybe any concerns regarding the ability of the patient to complete the study safely or any contraindications.
Concurrent weight loss or dietary programs will be ineligible if require a specific diet or weight loss supplements.
Plan for prolonged travel during the study that would preclude adherence to prescribed diet. Willingness to comply during travel is not an exclusion.
Severe allergy to any legume (such as anaphylactic shock) or allergies to multiple legumes or if cross-contamination is a risk are not eligible.
Severe allergies such as anaphylactic shock to peanuts and/or tree nuts, such as cashews are not eligible.

What this trial measures

  • compare the rates of improvement in Quality Of Lifeup to 12 weeks

    using the Quality of Life Global Health Status at W13D1 Scoring will be based on standard EORTC criteria