High-Fiber Plant-Based Diet in People with Clonal Hematopoiesis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study examines whether adopting a high-fiber plant-based diet, with possible fermented foods and supplements, can enhance quality of life for patients with clonal hematopoiesis. Participants will complete surveys to measure changes in well-being while following the diet. Eligibility requires confirmed clonal hematopoiesis, adequate age and BMI, and the ability to provide dietary data and records. The study leverages MSK and affiliated New Jersey sites with electronic medical record sharing to track dietary impact. No formal phase designation is provided, and the protocol emphasizes dietary modification and patient-reported outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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.

Where it's running

• Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
  Basking Ridge, New Jersey, United States Recruiting
• Memorial Sloan Kettering Monmouth (All Protocol Activities)
  Middletown, New Jersey, United States Recruiting
• Memorial Sloan Kettering Bergen (All Protocol Activities)
  Montvale, New Jersey, United States Recruiting
• Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)
  Commack, New York, United States Recruiting
• Memorial Sloan Kettering Westchester (All Protocol Activities)
  Harrison, New York, United States Recruiting
• Memorial Sloan Kettering Cancer Center (All Protocol Activities)
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Urvi Shah, MD — Memorial Sloan Kettering Cancer Center
• Study coordinator: Urvi Shah, MD
• Email: ShahNutrivention@mskcc.org
• Phone: 646-608-3713

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.