RecruitingInterventional

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

NCT ID: NCT05640843Sponsor: Memorial Sloan Kettering Cancer CenterLast updated: 2026-04-16

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.

Arms & 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).

Outcome measures

Primary

Stool microbiome diversity at 12 weeks
To evaluate the change in stool microbiome diversity on a dietary vs supplement vs placebo intervention at 12 weeks when compared to baseline
Time frame: 12 weeks

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No

Inclusion Criteria: * 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). * If IgD MGUS/SMM then an IgD level \>50 mg/dL and an abnormal immunofixation is required (M spike criteria not required). * Age ≥18 years * Willingness to comply with all study-related procedures * ECOG performance status of 0-3 * Interested in learning to cook plant based recipes Exclusion Criteria: * 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 * Mental impairment leading to inability to cooperate * Enrollment onto any other therapeutic investigational study concurrently and up to 180 days prior to study start date * Concurrent pregnancy * Positive HBV, HCV or HIV PCR test will need to be treated first and once undetectable viral load patients may enroll * ≥ Grade 2 electrolyte abnormalities as defined by CTCAEv5.0 (need to be resolved before enrolling on study) * If in the opinion of the investigator there maybe any concerns regarding the ability of the patient to complete the study safely or any contraindications * Heavy drinker (defined as \>2 drinks per day or \>14 drinks per week) * Current self-reported illicit drug use (eg heroin, cocaine not marijuana) * Plan for prolonged travel during the study that would preclude adherence to prescribed diets * History of major gastrointestinal surgery (not including appendectomy or cholecystectomy) within 3 months of enrollment * If already taking curcumin or omega 3 supplements patients must be willing to stop it on the date of trial consent for study duration.