A Study Comparing Plant-Based Diet, Supplements, and Placebo in Adults With MGUS or Smoldering Multiple Myeloma to Measure Stool Butyrate Levels

What this Trial Is About

Researchers are studying how butyrate levels in stool change after following a plant-based diet for at least 12 weeks in people with monoclonal gammopathy of undetermined significance MGUS or smoldering multiple myeloma SMM. The study compares the effects of a plant-based diet, omega-3 fatty acid and curcumin supplements, and placebo on these butyrate levels. This randomized, placebo-controlled trial is conducted by Memorial Sloan Kettering Cancer Center to explore nutritional interventions in these conditions. Participants will be assigned to one of three groups a plant-based diet group receiving two premade meals daily for 12 weeks a supplement group taking algae omega-3 and curcumin supplements twice daily for 52 weeks or a placebo group receiving inactive supplements twice daily for 25 weeks. The plant-based diet includes low glycemic meals with legumes, vegetables, whole grains, and plant fats, coupled with dietary education and counseling every 4 weeks. During the study, participants will be monitored through stool samples to assess microbiome diversity at 12 weeks. They will receive ongoing dietary support and have access to study staff for questions. The study lasts up to 52 weeks depending on the group, with regular assessments to track adherence, safety, and changes in butyrate levels. The research aims to understand how diet and supplements affect gut health in MGUS and SMM patients.

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)