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)
NCT ID: NCT05640843
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
150 participants
INTERVENTIONAL
2022-11-29
2026-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Daily Harvest weekly
For 12 weeks, on the Daily Harvest weekly arm, patients will receive two premade meals per day, for lunch and dinner for 6 days weekly, prepared and shipped by U.S.-based company Daily Harvest weekly.
Whole Foods Plant-based Diet
The meals will have a low glycemic index and contain legumes, vegetables, whole grains, and plant-based fats that have undergone minimal processing. Detailed recommendations for snacks and breakfasts meeting the standard of a WFPBD will also be given to supplement their daily calorie needs with access to education materials. Patients will also receive dietary education and counselling from a research dietitian every 4 weeks for the 12-week intervention period. They will have access to the team for questions and support as needed
Supplements
For 12 weeks on the supplement arm, patients will be given algae omega 3 supplements (QWell pharmaceuticals) and curcumin supplements (Sabinsa pharmaceuticals) twice daily.
Algae Omega 3 + Curcumin
For 52 weeks on the supplement arm, patients will be given algae omega 3 supplements and curcumin supplements (Sabinsa pharmaceuticals) twice daily
Placebo
For 12 weeks on the placebo arm, patients will be given placebo supplements twice daily (QWell and Sabinsa pharmaceuticals).
Placebo supplements
For 25 weeks on the placebo arm, patients will be given placebo supplements twice daily (Veggie Doctor/M and M pharmaceuticals and Sabinsa pharmaceuticals).
Interventions
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Whole Foods Plant-based Diet
The meals will have a low glycemic index and contain legumes, vegetables, whole grains, and plant-based fats that have undergone minimal processing. Detailed recommendations for snacks and breakfasts meeting the standard of a WFPBD will also be given to supplement their daily calorie needs with access to education materials. Patients will also receive dietary education and counselling from a research dietitian every 4 weeks for the 12-week intervention period. They will have access to the team for questions and support as needed
Algae Omega 3 + Curcumin
For 52 weeks on the supplement arm, patients will be given algae omega 3 supplements and curcumin supplements (Sabinsa pharmaceuticals) twice daily
Placebo supplements
For 25 weeks on the placebo arm, patients will be given placebo supplements twice daily (Veggie Doctor/M and M pharmaceuticals and Sabinsa pharmaceuticals).
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
ALL
No
Sponsors
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Paula and Rodger Riney Foundation
UNKNOWN
Plantable
UNKNOWN
M and M labs
UNKNOWN
VeggieDoctor
UNKNOWN
Sabinsa pharmaceuticals
UNKNOWN
Daily Harvest
UNKNOWN
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Urvi A Shah, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Emory University (Data Collection Only)
Atlanta, Georgia, United States
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 (All 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
Countries
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Central Contacts
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Alexander Lesokhin, MD
Role: CONTACT
Phone: 646-608-3717
Facility Contacts
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Nisha Joseph, MD
Role: primary
Urvi A Shah, MD, MS
Role: primary
Urvi A Shah, MD, MS
Role: primary
Urvi A Shah, MD, MS
Role: primary
Urvi A Shah, MD, MS
Role: primary
Urvi A Shah, MD, MS
Role: primary
Urvi A Shah, MD, MS
Role: primary
Urvi A Shah, MD, MS
Role: primary
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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22-175
Identifier Type: -
Identifier Source: org_study_id