A Dietary Study for People With Clonal Hematopoiesis

A Decentralized High-Fiber Dietary Intervention Trial in Clonal Hematopoiesis - NUTRIVENTION-CH

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.

Study Overview

• Status: Recruiting
• Conditions: Clonal Hematopoiesis
• Intervention / Treatment: Other: high-fiber plant-based meals; Other: fermented foods; Dietary supplement: supplements; Other: surveys

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Urvi Shah, MD; Phone Number: 646-608-3713; Email: ShahNutrivention@mskcc.org
• Study Contact Backup: Name: Tamanna Haque, MD; Phone Number: 646-608-4166

Study Locations

• United States
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Recruiting
      • Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
      • Contact: Urvi Shah, MD; Phone Number: 646-608-3713
    • Middletown, New Jersey, United States, 07748
      • Recruiting
      • Memorial Sloan Kettering Monmouth (All Protocol Activities)
      • Contact: Urvi Shah, MD; Phone Number: 646-608-3713
    • Montvale, New Jersey, United States, 07645
      • Recruiting
      • Memorial Sloan Kettering Bergen (All Protocol Activities)
      • Contact: Urvi Shah, MD; Phone Number: 646-608-3713
  • New York
    • Commack, New York, United States, 11725
      • Recruiting
      • Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)
      • Contact: Urvi Shah, MD; Phone Number: 646-608-3713
    • Harrison, New York, United States, 10604
      • Recruiting
      • Memorial Sloan Kettering Westchester (All Protocol Activities)
      • Contact: Urvi Shah, MD; Phone Number: 646-608-3713
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center (All protocol activities)
      • Contact: Urvi Shah, MD; Phone Number: 646-608-3713; Email: ShahNutrivention@mskcc.org
      • Contact: Tamanna Haque, MD; Phone Number: 646-608-4166
    • Uniondale, New York, United States, 11553
      • Recruiting
      • Memorial Sloan Kettering Nassau (All protocol activities)
      • Contact: Urvi Shah, MD; Phone Number: 646-608-3713

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High Fiber Plant-Based Diet; 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; A meal service will ship 12 frozen prepared meals per week to your home.; Other: fermented foods; Fermented foods will be encouraged on the diet. Fermented foods contain probiotics that help support a balanced gut microbiome and might improve overall digestion.; Dietary supplement: supplements; Patients will be recommended by research dietitian to take a weekly vitamin B12 supplement (at least 500 mcg weekly); Other: surveys; QOL will be measured with the EORTC QLQ C30
Active Comparator: Usual care arm; 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; QOL will be measured with the EORTC QLQ C30

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Urvi Shah, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: May 7, 2026
• First Submitted That Met QC Criteria: May 12, 2026
• First Posted (Actual): May 15, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: High-Fiber Plant Diet
• Additional Relevant MeSH Terms: Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Surveys and Questionnaires; Fermented Foods
• Other Study ID Numbers: 26-086

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No