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)

Study Overview
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Brief Summary
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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.

Official Title
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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 (NUTRIVENTION3) Study

Conditions
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Multiple Myeloma, Monoclonal Gammopathy of Undetermined Significance

Intervention / Treatment
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* Other: Whole Foods Plant-based Diet
* Dietary Supplement: Algae omega 3
* Other: Placebo supplements


Participation Criteria
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Eligibility Criteria
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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 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a randomized, multi-center pilot study with 150 patients (50 per arm). Randomization will be stratified based on BMI and MGUS/SMM status. Randomization in the supplement and placebo arms will be blinded.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Whole Foods Plant-based Diet<br>For 12 weeks, on the WFPBD arm, patients will receive two premade meals per day, for lunch and dinner for 6 days weekly, prepared and shipped by U.S.-based WFPBD company Plantable weekly. | Other: Whole Foods Plant-based Diet<br>* The meals will have a low glycemic index and contain 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 an online portal from Plantable which contains education materials and access to a health coach daily. 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<br>|
| Experimental: Supplements<br>For 12 weeks on the supplement arm, patients will be given algae omega 3 supplements (QWell pharmaceuticals) and curcumin supplements (Sabinsa pharmaceuticals) twice daily. | Dietary Supplement: Algae omega 3<br>* Algae omega 3 given twice daily.<br>|
| Placebo Comparator: Placebo<br>For 12 weeks on the placebo arm, patients will be given placebo supplements twice daily (QWell and Sabinsa pharmaceuticals). | Other: Placebo supplements<br>* Placebo supplements given twice daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in stool butyrate levels | change in stool butyrate levels on a dietary vs supplement vs placebo intervention at 12 weeks when compared to baseline | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Plant-Based Diet, Supplements, 22-175