Actively Recruiting
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
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-16
180
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
P
Paula and Rodger Riney Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how butyrate levels in stool change after following a plant-based diet for at least 12 weeks in people with monoclonal gammopathy of undetermined significance (MGUS) or smoldering multiple myeloma (SMM). The study compares the effects of a plant-based diet, omega-3 fatty acid and curcumin supplements, and placebo on these butyrate levels. This randomized, placebo-controlled trial is conducted by Memorial Sloan Kettering Cancer Center to explore nutritional interventions in these conditions. Participants will be assigned to one of three groups: a plant-based diet group receiving two premade meals daily for 12 weeks; a supplement group taking algae omega-3 and curcumin supplements twice daily for 52 weeks; or a placebo group receiving inactive supplements twice daily for 25 weeks. The plant-based diet includes low glycemic meals with legumes, vegetables, whole grains, and plant fats, coupled with dietary education and counseling every 4 weeks. During the study, participants will be monitored through stool samples to assess microbiome diversity at 12 weeks. They will receive ongoing dietary support and have access to study staff for questions. The study lasts up to 52 weeks depending on the group, with regular assessments to track adherence, safety, and changes in butyrate levels. The research aims to understand how diet and supplements affect gut health in MGUS and SMM patients.
CONDITIONS
Brief Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of monoclonal gammopathy of undetermined significance (MGUS) or smoldering multiple myeloma (SMM)
- For non light chain MGUS/SMM, M spike must be 65 0.2 g/dL or bone marrow plasma cells 6510% (both not required)
- For light chain MGUS/SMM, involved light chain must be 6510 mg/dL or bone marrow plasma cells 6510% (both not required)
- For IgA MGUS/SMM, IgA level must be greater than 350 mg/dL and abnormal immunofixation is required
- For IgD MGUS/SMM, IgD level must be greater than 50 mg/dL and abnormal immunofixation is required
- Age 18 years or older
- Willingness to comply with all study-related procedures
- ECOG performance status of 0 to 3
- Interest in learning to cook plant-based recipes
You will not qualify if you...
- Currently follow a whole foods plant-based diet (ovo-lacto-vegetarian or processed junk food vegan diets allowed)
- Allergy to legumes
- Severe allergies such as anaphylactic shock to nuts, specifically cashews (peanuts not included)
- Participation in weight loss, dietary, or exercise programs concurrently
- Mental impairment preventing cooperation
- Enrollment in any other therapeutic investigational study concurrently or within 180 days prior to study start
- Pregnancy
- Positive HBV, HCV, or HIV PCR test requiring treatment before enrollment
- Grade 2 or higher electrolyte abnormalities not resolved before enrollment
- Investigator concerns about safety or contraindications
- Heavy alcohol use (>2 drinks per day or >14 drinks per week)
- Current illicit drug use (heroin, cocaine, excluding marijuana)
- Planned prolonged travel interfering with diet adherence
- History of major gastrointestinal surgery within 3 months prior to enrollment (excluding appendectomy or cholecystectomy)
- Currently taking curcumin or omega-3 supplements and unwilling to stop at trial consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks for diet and placebo arms; 12 weeks for diet arm; 52 weeks for supplement arm
Participants receive one of three interventions: a whole foods plant-based diet with dietary counseling, algae omega 3 and curcumin supplements twice daily, or placebo supplements twice daily.
Diet arm: dietary counseling every 4 weeks; Supplement and placebo arms: twice daily dosing
Trial Site Locations
Total: 8 locations
1
Emory University (Data Collection Only)
Atlanta, Georgia, United States, 30322
Actively Recruiting
2
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
3
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
4
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
5
Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
6
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
7
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
8
Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
U
Urvi A Shah, MD, MS
A
Alexander Lesokhin, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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