36 Participants NeededMy employer runs this trial

High-Fiber Plant-Based Diet for Clonal Hematopoiesis

Recruiting at 6 trial locations
US
Overseen ByUrvi Shah, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Memorial Sloan Kettering Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a high-fiber, plant-based diet can improve the quality of life for individuals with clonal hematopoiesis (CH), a condition where blood cells develop mutations. Participants will either follow this diet with support from a dietitian or continue with their usual care. The trial focuses on how dietary changes may affect day-to-day well-being, tracked through surveys. Ideal participants have CH confirmed through specific tests, a body mass index (BMI) of 25 or higher, consume less than 30 grams of fiber daily, and are open to trying new recipes. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on diet and well-being.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on GLP-1 drugs, you can participate if you've been on a stable dose for at least 3 months.

What prior data suggests that a high-fiber plant-based diet is safe for people with clonal hematopoiesis?

Research has shown that a high-fiber plant-based diet (HFPBD) is generally safe for people. Studies have found that this diet is easy to follow and can improve health in several ways. For example, one study found that the HFPBD was safe and practical, enhancing diet quality and gut health over 12 weeks. Another study noted that this diet boosted metabolism and immune function without causing serious side effects.

These findings suggest that following an HFPBD could safely improve quality of life, especially for those with certain health conditions. However, consulting a healthcare provider before making any dietary changes is always important to ensure they suit individual health needs.12345

Why are researchers excited about this trial?

Unlike the standard of care for clonal hematopoiesis, which often involves monitoring and lifestyle advice, the high-fiber plant-based diet offers a fresh approach. This diet is unique because it aims to improve health by increasing fiber intake through plant-based meals, potentially impacting blood health and reducing the progression of clonal hematopoiesis. Researchers are excited because this diet focuses on a non-invasive, nutrition-based intervention that could enhance overall well-being and provide a novel way to manage this condition.

What evidence suggests that a high-fiber plant-based diet could improve quality of life for people with clonal hematopoiesis?

This trial will compare a high-fiber, plant-based diet with usual care for participants with clonal hematopoiesis. Studies have shown that such a diet can benefit health. Research suggests it might improve key health indicators related to metabolism and the immune system. High-fiber diets have been linked to slower progression of diseases related to blood disorders, like multiple myeloma. Evidence also indicates that these diets can reduce risk factors for heart disease, enhancing overall well-being. For individuals with clonal hematopoiesis, these potential benefits suggest that a high-fiber, plant-based diet could improve quality of life.34567

Who Is on the Research Team?

US

Urvi Shah, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for people diagnosed with clonal hematopoiesis (CH). Participants should be able to follow a plant-based diet and complete surveys. Specific inclusion or exclusion details are not provided.

Inclusion Criteria

I am 18 years old or older.
I have CCUS and have had a bone marrow biopsy to rule out other causes.
BMI ≥25 kg/m^2
See 6 more

Exclusion Criteria

I am able to understand and follow instructions for the 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
Severe allergy to any legume (such as anaphylactic shock) or allergies to multiple legumes or if cross-contamination is a risk are not eligible
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a high-fiber plant-based diet with regular phone or video calls with a dietitian

52 weeks
Every 2 weeks for the first 12 weeks, every 4 weeks from Weeks 13-24, and every 8 weeks from Weeks 25-52

Follow-up

Participants are monitored for quality of life improvements using questionnaires/surveys

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • High-Fiber Plant-Based Diet

Trial Overview

The study tests if eating a high-fiber, plant-based diet—possibly with supplements and fermented foods—can improve quality of life in people with CH. Quality of life will be measured using questionnaires.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: High Fiber Plant-Based DietExperimental Treatment4 Interventions
Group II: Usual care armActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Citations

Association of Diet Quality With Prevalence of Clonal ... - PMC

The results of this study suggest that unhealthy eating habits may be associated with the development of clonal hematopoiesis of indeterminate potential.

A Dietary Study for People With Clonal Hematopoiesis

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 ...

A High-Fiber, Plant-Based Diet in Myeloma Precursor Disorders

A high-fiber, plant-based diet improved metabolic, microbiome, and immune biomarkers in patients with MGUS/SMM and delayed myeloma progression in mouse.

A Dietary Study for People With Clonal Hematopoiesis

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.

High-Fiber Diet Tied to Slower Multiple Myeloma ...

High-fiber diets may play a role in hematologic malignancies, from slowing disease progression in precursor conditions of multiple myeloma ...

High-fiber plant-based diet could benefit patients at risk for ...

Results from a new clinical trial suggest that a high-fiber plant-based diet could benefit patients at risk for developing multiple myeloma.

High-Fiber Plant-Based Diet for Clonal Hematopoiesis

The study tests if eating a high-fiber, plant-based diet—possibly with supplements and fermented foods—can improve quality of life in people with CH. Quality of ...