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

150 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

Inclusion Criteria9

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 Criteria15

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.

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).