Actively Recruiting
A Decentralized High-Fiber Dietary Intervention Trial in Clonal Hematopoiesis - NUTRIVENTION-CH
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-05-15
36
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether a high-fiber plant-based diet (HFPBD) can improve quality of life for people with clonal hematopoiesis (CH). This diet mainly includes plant foods such as fruits, vegetables, nuts, beans, and whole grains. The study measures quality of life using questionnaires and surveys filled out by participants. Participants will be randomly assigned to one of two groups. One group will receive high-fiber plant-based meals delivered to their homes for 12 weeks and have regular phone or video calls with a dietitian every 2 weeks for the first 12 weeks, every 4 weeks from weeks 13 to 24, and every 8 weeks from weeks 25 to 52. The other group will receive usual care with phone calls every 4 weeks for the first 12 weeks and dietitian calls at weeks 13 and 53. During the study, participants will complete quality of life surveys using the EORTC QLQ C30 questionnaire. Assessments include phone or video visits with dietitians, dietary intake monitoring, and adherence to the assigned diet. The main outcome is improvement in quality of life within the first 12 weeks. The total study duration for participants is 52 weeks, with ongoing monitoring and support throughout this time.
CONDITIONS
Brief Title
A Dietary Study for People With Clonal Hematopoiesis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 65% for mutation as measured by NGS
- Treatment at MSK or sites using EPIC electronic medical records willing to share records with MSK
- Age 18 years or older
- Body mass index (BMI) 25 kg/m or higher
- Participant or caregiver must be able to complete surveys and have interest in trying new recipes or cooking
- Screening 24-hour dietary recall must show less than 30 grams dietary fiber per day
- For patients at MSK, bone marrow biopsy at screening within past 24 weeks with research biobanking sample collection; biopsy at other sites is optional
You will not qualify if you...
- Prior therapy directed at myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)
- Chemotherapy, radiation, or immunotherapy within the past year (surgery only or observation for other cancers allowed)
- Concurrent malignancy that may interfere with trial completion
- Current pregnancy
- Following a minimally processed whole food plant-based diet in the last 3 months (ovo-lacto-vegetarian or processed junk food vegan diets allowed)
- Mental impairment preventing cooperation
- Investigator concerns about ability to safely complete the study
- Concurrent weight loss or dietary programs requiring specific diet or supplements
- Plans for prolonged travel that would prevent diet adherence
- Severe allergies to legumes or nuts with risk of anaphylactic shock or cross-contamination
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (phone or video call)
Duration - 52 weeks
Participants follow either a high-fiber plant-based diet with delivered meals and regular dietitian support or usual care with periodic phone calls to support dietary habits.
Phone or video calls every 2 weeks for the first 12 weeks, every 4 weeks from Weeks 13-24, and every 8 weeks from Weeks 25-52 for the high-fiber diet group; phone calls every 4 weeks for the first 12 weeks, then calls at Weeks 13 and 53 for the usual care group
Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
U
Urvi Shah, MD
T
Tamanna Haque, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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