NCT05640843

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

Recruiting now NA Last updated 15 April 2026

What this trial tests

NA trial testing Whole Foods Plant-based Diet in Monoclonal Gammopathy of Undetermined Significance in 180 participants. Currently enrolling.

Timeline

29 November 2022

Primary endpoint
1 November 2026

1 November 2026

Quick facts

Lead sponsor	Memorial Sloan Kettering Cancer Center
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	180
Start date	29 November 2022
Primary completion	1 November 2026
Estimated completion	1 November 2026
Sites	8 locations across United States

Drugs / interventions tested

• Whole Foods Plant-based Diet
• Algae Omega 3 + Curcumin
• Placebo supplements

Conditions studied

• Monoclonal Gammopathy of Undetermined Significance — all drugs for Monoclonal Gammopathy of Undetermined Significance →
• Smoldering Multiple Myeloma — all drugs for Smoldering Multiple Myeloma →

Sponsor

Memorial Sloan Kettering Cancer Center — full company profile →

Who can join

18 and older, any sex, with Monoclonal Gammopathy of Undetermined Significance or Smoldering Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Stool microbiome diversity at 12 weeks
  Time frame: 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

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Dietary and microbiome evidence in multiple myeloma and other plasma cell disorders.
   Shah UA, Parikh R, Castro F, Bellone M, et al · · 2023 · cited 28× · PMID 36997677 · DOI 10.1038/s41375-023-01874-4
2. Diagnosis and Management of Monoclonal Gammopathy of Undetermined Significance: A Review.
   Liu Y, Parks AL. · · 2025 · cited 8× · PMID 39960681 · DOI 10.1001/jamainternmed.2024.8124
3. Pre-diagnosis dietary patterns and risk of multiple myeloma in the NIH-AARP diet and health study.
   Castro F, Parikh R, Eustaquio JC, Derkach A, et al · · 2024 · cited 6× · PMID 38158443 · DOI 10.1038/s41375-023-02132-3
4. A High-Fiber, Plant-Based Diet in Myeloma Precursor Disorders: Results from the NUTRIVENTION Clinical Trial and Preclinical Vk*MYC Model.
   Shah UA, Cogrossi LL, Garcés JJ, Policastro A, et al · · 2026 · cited 4× · PMID 41342739 · DOI 10.1158/2159-8290.cd-25-1101
5. Unlocking the Therapeutic Potential of Algae-Derived Compounds in Hematological Malignancies.
   Vujović T, Paradžik T, Babić Brčić S, Piva R. · · 2025 · cited 4× · PMID 39858100 · DOI 10.3390/cancers17020318
6. Conceptualizing an Integrative Multiple Myeloma Care: The Role of Nutrition, Supplements, and Complementary Modalities.
   Andreazzoli F, Levy Yurkovski I, Ben-Arye E, Bonucci M. · · 2024 · cited 3× · PMID 38257130 · DOI 10.3390/nu16020237
7. Phytochemicals in overcoming venetoclax resistance in acute myeloid leukemia: mechanistic insights and therapeutic potential.
   Prajapati S, Patel M, Jyotishi C, Gupta R. · · 2025 · cited 2× · PMID 41201585 · DOI 10.1007/s00277-025-06710-6
8. Racial differences in the proportion of myeloma cases attributable to excess body weight and diabetes mellitus in the United States.
   Anuraj A, Rath D, Derkach A, Usmani SZ, et al · · 2026 · cited 2× · PMID 40836775 · DOI 10.3324/haematol.2025.287724