A Dietary Study for People With Clonal Hematopoiesis

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT07590804
Status
Recruiting
Apply to this trial

Conditions

  • Clonal Hematopoiesis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • high-fiber plant-based meals — OTHER
    A meal service will ship 12 frozen prepared meals per week to your home.
  • 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.
  • supplements — DIETARY_SUPPLEMENT
    Patients will be recommended by research dietitian to take a weekly vitamin B12 supplement (at least 500 mcg weekly)
  • surveys — OTHER
    QOL will be measured with the EORTC QLQ C30

Study Details

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.

Key Dates

Start date
May 4, 2026
Status verified
May 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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).

Primary Outcome Measure

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

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)Basking RidgeNew Jersey07920
Urvi Shah, MD
646-608-3713
Memorial Sloan Kettering Monmouth (All Protocol Activities)MiddletownNew Jersey07748
Urvi Shah, MD
646-608-3713
Memorial Sloan Kettering Bergen (All Protocol Activities)MontvaleNew Jersey07645
Urvi Shah, MD
646-608-3713
Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)CommackNew York11725
Urvi Shah, MD
646-608-3713
Memorial Sloan Kettering Westchester (All Protocol Activities)HarrisonNew York10604
Urvi Shah, MD
646-608-3713
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065
Urvi Shah, MD
[email protected]
646-608-3713
Tamanna Haque, MD
646-608-4166
Memorial Sloan Kettering Nassau (All Protocol Activities)UniondaleNew York11553
Urvi Shah, MD
646-608-3713

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Memorial Sloan Kettering Basking Ridge (All Protocol Activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (All Protocol Activities)· Middletown, NJMemorial Sloan Kettering Bergen (All Protocol Activities)· Montvale, NJMemorial Sloan Kettering Suffolk- Commack (All Protocol Activities)· Commack, NYMemorial Sloan Kettering Westchester (All Protocol Activities)· Harrison, NYMemorial Sloan Kettering Cancer Center (All Protocol Activities)· New York, NY

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