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.
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).
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
Parallel
Whole Foods Plant-based Diet
Other interventionThe 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
Algae Omega 3 + Curcumin
Dietary supplementFor 52 weeks on the supplement arm, patients will be given algae omega 3 supplements and curcumin supplements (Sabinsa pharmaceuticals) twice daily
Placebo supplements
Other interventionFor 25 weeks on the placebo arm, patients will be given placebo supplements twice daily (Veggie Doctor/M and M pharmaceuticals and Sabinsa pharmaceuticals).
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
Click on the lead sponsor to view all of their trials.
Memorial Sloan Kettering Cancer Center
Lead sponsor
Paula and Rodger Riney Foundation
Collaborator
Plantable
Collaborator
M and M labs
Collaborator
VeggieDoctor
Collaborator
Sabinsa pharmaceuticals
Collaborator
Daily Harvest
Collaborator
