RecruitingNot ApplicableNCT06055894

A Study of a Plant-Based Diet and Dietary Supplements in People With Smoldering Multiple Myeloma (SMM) or Monoclonal Gammopathy of Undetermined Significance (MGUS)

Microbial Changes in Response to a Plant Based Diet and/or Supplements in SMM/MGUS Patients: A National Multi-Arm Randomized Prospective Telehealth Study Via HealthTree


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

200 participants

Start Date

Sep 20, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The researchers are going this to look at how butyrate levels change in participants' stool after they are on a plant-based diet or dietary supplements (omega-3, curcumin or probiotics) for 2 weeks. All participants will have smoldering multiple myeloma (SMM) or monoclonal gammopathy of undetermined significance (MGUS). The researchers will compare how the different dietary changes affect butyrate levels in participants' stool.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is examining whether a whole-food, plant-based diet combined with dietary supplements can slow the progression of early-stage blood cancers — specifically smoldering multiple myeloma (SMM) or monoclonal gammopathy of undetermined significance (MGUS) — conditions that are precursors to full multiple myeloma. **You may be eligible if...** - You have been diagnosed with MGUS or smoldering multiple myeloma confirmed within the past 6 months - You are 18 years or older and live in the United States - You have access to a smartphone with camera and can download an app - You are interested in learning to prepare plant-based meals **You may NOT be eligible if...** - You have already progressed to active multiple myeloma requiring treatment - You are unable to physically complete the study requirements and have no one to assist you - You do not have access to a smart device Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTOmega-3

For 2 weeks, patients will receive omega 3 fatty acid supplements 1640 mg (2 capsules) twice daily

DIETARY_SUPPLEMENTCurcumin

For 2 weeks, patients in the curcumin arm will receive Curcumin C3 complex 1000 mg with 5 mg BioPerine twice daily

DIETARY_SUPPLEMENTProbiotic

For 2 weeks, patients in the probiotic arm will receive Ultra-50 probiotics with 50 billion CFU per capsule (one capsule) twice daily

OTHERWhole food, plant-based diet (WFPBD)

Daily Harvest once a week. The meals will have range from 2 breakfast, 11 lunch/dinners, 1 snack (provided Week 1), and whole grains items (provided Week 2).


Locations(7)

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Commack, New York, United States

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Memorial Sloan Kettering Nassau (All Protocol Activities)

Uniondale, New York, United States

View Full Details on ClinicalTrials.gov

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NCT06055894


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