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)

A Randomized Placebo Controlled Study of a Plant-Based Dietary Versus Supplement Versus Placebo Intervention in Patients With Monoclonal Gammopathy of Undetermined Significance (MGUS) and Smoldering Multiple Myeloma (SMM) - The Nutrition Prevention (NUTRIVENTION-3) Study

The researchers are doing this study to look at how butyrate levels change in participants' stool after they are on a- plant-based diet for at least 12 weeks. All participants will have monoclonal gammopathy of undetermined significance (MGUS) or smoldering multiple myeloma (SMM). We will compare how the plant-based diet, omega-3 fatty acid and curcumin supplements, and placebo (an inactive substance that looks like the study supplements) affect butyrate levels in participants' stool.

Study Overview

• Status: Recruiting
• Conditions: Monoclonal Gammopathy of Undetermined Significance; Smoldering Multiple Myeloma
• Intervention / Treatment: Other: Whole Foods Plant-based Diet; Dietary supplement: Algae Omega 3 + Curcumin; Other: Placebo supplements

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexander Lesokhin, MD; Phone Number: 646-608-3717
• Study Contact Backup: Name: Urvi A Shah, MD, MS; Phone Number: 646-608-3713; Email: ShahNutrivention@mskcc.org

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Emory University (Data Collection Only)
      • Contact: Nisha Joseph, MD; Phone Number: 404-778-0519
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Recruiting
      • Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
      • Contact: Urvi A Shah, MD, MS; Phone Number: 646-608-3713
    • Middletown, New Jersey, United States, 07748
      • Recruiting
      • Memorial Sloan Kettering Monmouth (All Protocol Activities)
      • Contact: Urvi A Shah, MD, MS; Phone Number: 646-608-3713
    • Montvale, New Jersey, United States, 07645
      • Recruiting
      • Memorial Sloan Kettering Bergen (All Protocol Activities)
      • Contact: Urvi A Shah, MD, MS; Phone Number: 646-608-3713
  • New York
    • Commack, New York, United States, 11725
      • Recruiting
      • Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)
      • Contact: Urvi A Shah, MD, MS; Phone Number: 646-608-3713
    • Harrison, New York, United States, 10604
      • Recruiting
      • Memorial Sloan Kettering Westchester (All Protocol Activities)
      • Contact: Urvi A Shah, MD, MS; Phone Number: 646-608-3713
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
      • Contact: Urvi A Shah, MD, MS; Phone Number: 646-608-3713
    • Uniondale, New York, United States, 11553
      • Recruiting
      • Memorial Sloan Kettering Nassau (All protocol activities)
      • Contact: Urvi A Shah, MD, MS; Phone Number: 646-608-3713

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: 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 Comparator: Placebo; For 12 weeks on the placebo arm, patients will be given placebo supplements twice daily (QWell and Sabinsa pharmaceuticals).	Other: 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).
Experimental: 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.	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stool microbiome diversity at 12 weeks	To evaluate the change in stool microbiome diversity on a dietary vs supplement vs placebo intervention at 12 weeks when compared to baseline	12 weeks

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: Paula and Rodger Riney Foundation; Plantable; M and M labs; VeggieDoctor; Sabinsa pharmaceuticals; Daily Harvest
• Investigators: Principal Investigator: Urvi A Shah, MD, MS, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2022
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: November 29, 2022
• First Submitted That Met QC Criteria: November 29, 2022
• First Posted (Actual): December 7, 2022

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Plant-Based Diet; Supplements; 22-175
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Hematologic Diseases; Immunoproliferative Disorders; Precancerous Conditions; Paraproteinemias; Blood Protein Disorders; Hypergammaglobulinemia; Hemic and Lymphatic Diseases; Smoldering Multiple Myeloma; Monoclonal Gammopathy of Undetermined Significance; Organic Chemicals; Hydrocarbons, Acyclic; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Diarylheptanoids; Heptanes; Alkanes; Catechols; Phenols; Benzene Derivatives; Curcumin
• Other Study ID Numbers: 22-175

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No