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)

Official 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

Overview

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.

Interventions

• Other Whole 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 f
• Dietary supplement Algae 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
• Other Placebo 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).

Primary outcome measures

• Stool microbiome diversity at 12 weeks [Time frame: 12 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 8 centers

• Emory University (Data Collection Only) — Atlanta
• Memorial Sloan Kettering Basking Ridge (All Protocol Activities) — Basking Ridge
• Memorial Sloan Kettering Monmouth (All Protocol Activities) — Middletown
• Memorial Sloan Kettering Bergen (All Protocol Activities) — Montvale
• Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities) — Commack
• Memorial Sloan Kettering Westchester (All Protocol Activities) — Harrison
• Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York
• Memorial Sloan Kettering Nassau (All Protocol Activities) — Uniondale

Identifiers

NCT: NCT05640843 · 22-175

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗