Study on How Plant-Based High-Fiber Diets Affect Gut Microbiome and Metabolites in Adults with Smoldering Multiple Myeloma

What this Trial Is About

Researchers are investigating how plant-based diets affect the gut microbiome and related metabolites in patients with smoldering multiple myeloma sMM. The study aims to show that diets rich in fiber can promote beneficial gut bacteria that produce short-chain fatty acids SCFAs, potentially preventing progression to multiple myeloma. This national, multicenter study involves up to 62 sMM patients and focuses on the impact of dietary changes on gut health and immune balance. Participants will be encouraged to follow a balanced, high-fiber diet for 12 weeks, choosing from various diet plans based on their preferences. Medical visits will take place at enrollment and at week 12, with nutritional counseling provided initially, at one month, and as needed. Stool and blood samples will be collected before the diet starts, and again at 4 and 12 weeks to monitor changes in the gut microbiome and SCFA levels. Dietary adherence will be tracked daily through questionnaires and food diaries. During the study, participants will have routine medical visits and sample collections aligned with standard sMM follow-up care. Researchers will compare biological data from baseline and follow-up samples to assess diet effects on SCFA concentration and gut microbiome composition. Evaluation of diet adherence and safety monitoring will also be ongoing throughout the trial, lasting 12 weeks with encouragement to continue plant-based eating beyond this period.

A Prospective Multicenter Study of the Effects of Plant-based Diets on Gut Microbiome and Derived Metabolites in Patients Affected by Smoldering Multiple Myeloma