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)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center

About this trial

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.

Eligibility criteria

Qualifiers

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).

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

180 Participants
are divided into 3 treatment groups

Sponsors and collaborators

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