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Plant-Based Diet Study for MGUS and SMM

This study is looking at how a plant-based diet, with or without certain supplements, affects people with Monoclonal Gammopathy of Undetermined Significance (MGUS) or Smoldering Multiple Myeloma (SMM). Researchers want to see how butyrate levels (a substance in your gut) change in your stool after being on a plant-based diet for at least 12 weeks. You would either receive a Whole Foods Plant-based Diet, or the diet along with Algae Omega 3 and Curcumin supplements, or the diet with placebo supplements (inactive substances that look like the real supplements). To join, you must be 18 or older and have a confirmed diagnosis of MGUS or SMM, meeting specific criteria for M spike or light chain levels. The study aims to enroll 180 participants, but its current status is unclear.

Study design
This interventional study plans to enroll 180 participants. It compares different interventions: a plant-based diet alone, a plant-based diet with Algae Omega 3 and Curcumin supplements, and a plant-based diet with placebo supplements.
What's involved
Participants on the supplement arm will take Algae Omega 3 and Curcumin supplements twice daily for 52 weeks. Participants on the placebo arm will take placebo supplements twice daily for 25 weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, stool microbiome diversity, is measured at 12 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05640843

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

Recruiting
NAAges 18+InterventionalTreatment
Memorial Sloan Kettering Cancer Center
~180 participants
Updated 2026-04-16 on ClinicalTrials.gov
What's tested:Whole Foods Plant-based DietAlgae Omega 3 + CurcuminPlacebo supplements

At a glance

Recruiting sites
8 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Stool microbiome diversity at 12 weeks
Measured over 12 weeks

Conditions

Monoclonal Gammopathy of Undetermined Significance
Smoldering Multiple Myeloma

Explore related trials

Monoclonal Gammopathy of Undetermined SignificanceSmoldering Multiple Myeloma

Where it's being run

8 sites across 3 states
New York4
New Jersey3
Georgia1

Study leadership

  • Urvi A Shah, MD, MS · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Urvi A Shah, MD, MS
[email protected]
646-608-3713
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Confirmed diagnosis of MGUS or SMM
If non light chain MGUS/SMM then M spike must be either ≥ 0.2 g/dL or BM PC ≥10% (both not required)
If light chain MGUS/SMM then involved must be ≥10 mg/dL or BM PC ≥10% (both not required)
If IgA MGUS/SMM then an IgA level \>350 mg/dL and an abnormal immunofixation is required (M spike criteria not required).
If IgD MGUS/SMM then an IgD level \>50 mg/dL and an abnormal immunofixation is required (M spike criteria not required).
Age ≥18 years
Willingness to comply with all study-related procedures
ECOG performance status of 0-3
Interested in learning to cook plant based recipes

Exclusion

Patients that already follow a whole foods plant based diet (ovo-lacto-vegetarian or processed junk food vegan diets are not excluded)
Legume allergy
Severe allergies such as anaphylactic shock to nuts (specifically cashews). Peanuts are not included in the meals.
Concurrent participation in weight loss/dietary/exercise programs
Mental impairment leading to inability to cooperate
Enrollment onto any other therapeutic investigational study concurrently and up to 180 days prior to study start date
Concurrent pregnancy
Positive HBV, HCV or HIV PCR test will need to be treated first and once undetectable viral load patients may enroll
≥ Grade 2 electrolyte abnormalities as defined by CTCAEv5.0 (need to be resolved before enrolling on study)
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
Heavy drinker (defined as \>2 drinks per day or \>14 drinks per week)
Current self-reported illicit drug use (eg heroin, cocaine not marijuana)
Plan for prolonged travel during the study that would preclude adherence to prescribed diets
History of major gastrointestinal surgery (not including appendectomy or cholecystectomy) within 3 months of enrollment
If already taking curcumin or omega 3 supplements patients must be willing to stop it on the date of trial consent for study duration.

What this trial measures

  • Stool microbiome diversity at 12 weeks12 weeks

    To evaluate the change in stool microbiome diversity on a dietary vs supplement vs placebo intervention at 12 weeks when compared to baseline