RecruitingNot ApplicableNCT05640843

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)

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

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

180 participants

Start Date

Nov 29, 2022

Study Type

INTERVENTIONAL

Conditions

Monoclonal Gammopathy of Undetermined Significance Smoldering Multiple Myeloma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing a whole-food plant-based diet (with supplements) against a placebo in people with MGUS or smoldering multiple myeloma — early, not-yet-treated blood conditions that can sometimes develop into multiple myeloma — to see if diet changes can slow disease progression. **You may be eligible if...** - You have been diagnosed with MGUS (monoclonal gammopathy of undetermined significance) or smoldering multiple myeloma - You are 18 years or older - You are in reasonably good health (ECOG 0–3) - You are interested in learning to cook plant-based recipes and willing to follow the study diet **You may NOT be eligible if...** - You already follow a strict whole-food plant-based diet - Your blood cancer has progressed to active multiple myeloma requiring treatment - You are unwilling or unable to comply with the study requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERWhole 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_SUPPLEMENTAlgae 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

OTHERPlacebo 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).