Recruiting

High-Fiber Plant-Based Diet

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT07590804

Conditions

Clonal Hematopoiesis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

high-fiber plant-based meals

fermented foods

supplements

surveys

Study Details

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

Study ID

NCT07590804

Start date

May 4, 2026

Status verified date

May, 2026

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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

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).

Interventions

high-fiber plant-based meals

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

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.

supplements

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

surveys

QOL will be measured with the EORTC QLQ C30

Primary outcome measure

  • compare the rates of improvement in Quality Of Life [ Time Frame: up to 12 weeks ]

Central Contacts and Locations

Central contacts

Urvi Shah, MD

646-608-3713ShahNutrivention@mskcc.org

Tamanna Haque, MD

646-608-4166

Locations

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Urvi Shah, MD

646-608-3713

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Urvi Shah, MD

646-608-3713

Memorial Sloan Kettering Bergen (All Protocol Activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Urvi Shah, MD

646-608-3713

Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)

Recruiting

Commack, New York, United States, 11725

Contacts

Urvi Shah, MD

646-608-3713

Memorial Sloan Kettering Westchester (All Protocol Activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Urvi Shah, MD

646-608-3713

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Recruiting

New York, New York, United States, 10065

Contacts

Urvi Shah, MD

646-608-3713ShahNutrivention@mskcc.org

Tamanna Haque, MD

646-608-4166

Memorial Sloan Kettering Nassau (All Protocol Activities)

Recruiting

Uniondale, New York, United States, 11553

Contacts

Urvi Shah, MD

646-608-3713

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

May 15, 2026

Last verified

May, 2026

Keywords

  • High-Fiber Plant Diet

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-05-15.