A Dietary Study for People With Clonal Hematopoiesis

NCT07590804 | Recruiting

• 1 other identifier: 26-086
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Clonal Hematopoiesis

Keywords

High-Fiber Plant Diet

Outcome Measures

Primary Outcomes (1)

• compare the rates of improvement in Quality Of Life

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

  up to 12 weeks

Study Arms (2)

High Fiber Plant-Based Diet

EXPERIMENTAL

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

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

Usual care arm

ACTIVE COMPARATOR

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).

Other: surveys

Interventions

high-fiber plant-based meals OTHER

A meal service will ship 12 frozen prepared meals per week to your home.

High Fiber Plant-Based Diet

fermented foods OTHER

Fermented foods will be encouraged on the diet. Fermented foods contain probiotics that help support a balanced gut microbiome and might improve overall digestion.

High Fiber Plant-Based Diet

supplements DIETARY_SUPPLEMENT

Patients will be recommended by research dietitian to take a weekly vitamin B12 supplement (at least 500 mcg weekly)

High Fiber Plant-Based Diet

surveys OTHER

QOL will be measured with the EORTC QLQ C30

High Fiber Plant-Based Diet; Usual care arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (7)

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau (All Protocol Activities)

Uniondale, New York, 11553, United States

RECRUITING

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Interventions

Fermented Foods; Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Urvi Shah, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Urvi Shah, MD

CONTACT

646-608-3713; ShahNutrivention@mskcc.org

Tamanna Haque, MD

CONTACT

646-608-4166

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 15, 2026
• Study Start: May 4, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

US (7)