A Study Comparing a Plant-Based Diet with Supplements and Placebo in People with Monoclonal Gammopathy of Undetermined Significance or Smoldering Multiple Myeloma

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Full Title

A Randomized Placebo Controlled Study of a Plant-Based Dietary versus Supplement versus Placebo Intervention in Patients with Monoclonal Gammopathy of Undetermined Significance (MGUS) and Smoldering Multiple Myeloma (SMM) - The Nutrition Prevention (NUTRIVENTION-3) Study

Purpose

Researchers want to know if eating a plant-based diet and taking certain nutritional supplements may be helpful for reducing the risk of progression to multiple myeloma in people with monoclonal gammopathy of undetermined significance (MGUS) or smoldering multiple myeloma (SMM). People with MGUS and SMM have an abnormal protein called the M protein in their blood and are at risk of developing multiple myeloma.

Butyrate is an important substance produced by the gut microbiome (the bacteria in the intestine) that works against cancer and inflammation. A plant-based diet may raise butyrate levels. In this study, researchers are observing how butyrate levels change in the stool of people with MGUS and SMM after following a plant-based diet and/or supplements for at least 12 weeks. Omega-3 fatty acid and curcumin supplements may also have positive effects on the gut microbiome.

All participants will be provided with plant-based meals as well as with dietary coaching from Plantable for at least 12 weeks of the study. Some participants will also take omega-3 fatty acid and curcumin supplements, or a placebo that looks like the active supplements but contains no active ingredient.

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have MGUS or SMM and may not already be following a whole-foods plant-based diet.
  • This study is for people age 18 and older.

Contact

For more information and to ask about eligibility for this study, please contact the office of Dr. Urvi Shah at 646-608-3713 or email Francesca Castro at [email protected].

Protocol

22-175

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

ClinicalTrials.gov ID

NCT05640843