A Dietary Study for People With Clonal Hematopoiesis

Memorial Sloan Kettering Cancer Center (MSK)

Status: Enrolling

Conditions: Clonal Hematopoiesis

Treatments: Other: high-fiber plant-based meals; Other: fermented foods; Dietary Supplement: supplements; Other: surveys

Study type: Interventional

Funder types: Other

Identifiers

NCT07590804

26-086

Details and patient eligibility

About

The researchers are doing this study to find out whether a high-fiber plant-based diet (HFPBD) can improve quality of life for people with CH. A HFPBD includes foods that are mainly from plants (for example, fruits,vegetables, nuts, beans, and whole grains). The researchers will measure quality of life by having participants complete questionnaires/surveys.

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

High Fiber Plant-Based Diet

Experimental group

Description:

Participants will have a phone call or video call with a dietitian every 2 weeks for the first 12 weeks, every 4 weeks from Weeks 13-24, and every 8 weeks from Weeks 25-52. Participants will receive high-fiber plant-based meals for 12 weeks

Treatment:

Other: surveys

Dietary Supplement: supplements

Other: fermented foods

Other: high-fiber plant-based meals

Usual care arm

Active Comparator group

Description:

Participants will have phone calls with a member of the study team every 4 weeks for the first 12 weeks. After the first 12 weeks, participants will have a phone call or video call with a dietitian at Weeks 13 and 53 (end of study).

Treatment:

Other: surveys