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)

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

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).

Sponsors & Collaborators

• Paula and Rodger Riney Foundation

  collaborator UNKNOWN

• Plantable

  collaborator UNKNOWN

• M and M labs

  collaborator UNKNOWN

• VeggieDoctor

  collaborator UNKNOWN

• Sabinsa pharmaceuticals

  collaborator UNKNOWN

• Daily Harvest

  collaborator UNKNOWN

• Memorial Sloan Kettering Cancer Center

  lead OTHER

Principal Investigators

• Urvi A Shah, MD, MS · Memorial Sloan Kettering Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-11-29

Primary Completion

2026-11-30

Completion

2026-11-30

Countries

• United States

Study Locations