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)

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Monoclonal Gammopathy of Undetermined Significance
• Smoldering Multiple Myeloma

Interventions

Type	Name	Description
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
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
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).

Timeline

• Start date: 2022-11-29
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2022-12-07
• Last updated: 2026-04-16

Locations

8 sites across 1 country: United States