RecruitingNot ApplicableNCT06055894

A Study of a Plant-Based Diet and Dietary Supplements in People With Smoldering Multiple Myeloma (SMM) or Monoclonal Gammopathy of Undetermined Significance (MGUS)

Microbial Changes in Response to a Plant Based Diet and/or Supplements in SMM/MGUS Patients: A National Multi-Arm Randomized Prospective Telehealth Study Via HealthTree

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

200 participants

Start Date

Sep 20, 2023

Study Type

INTERVENTIONAL

Conditions

Multiple Myeloma Monoclonal Gammopathy of Undetermined Significance Multiple Myeloma, Smoldering

Summary

The researchers are going this to look at how butyrate levels change in participants' stool after they are on a plant-based diet or dietary supplements (omega-3, curcumin or probiotics) for 2 weeks. All participants will have smoldering multiple myeloma (SMM) or monoclonal gammopathy of undetermined significance (MGUS). The researchers will compare how the different dietary changes affect butyrate levels in participants' stool.

Eligibility

Min Age: 18 Years

Inclusion Criteria8

Confirmed prior diagnosis MGUS or of smoldering myeloma (any time prior). However, confirmation of diagnosis must be documented in their last local oncologist clinic note within 6 months prior to study enrollment.
Age ≥18 years
Willingness to comply with all study-related procedures
Physically able to complete requirements for the study or has someone to assist with the requirements (such as meal preparation, stool shipment and survey completion)
Interested in learning to cook plant-based recipes
Access to smart mobile phone or device with camera and ability to download Keenoa app
Be residing within the United States for the study duration.
English speaking or a family member or caregiver who speaks English and is able to assist with the surveys and phone based Keenoa app.

Exclusion Criteria15

Taking any supplements other than vitamin D, iron, vitamin B12, potassium, magnesium, calcium or those needed for a medical indication must be reviewed by PI. If patient is on a supplement (including curcumin, probiotic, omega3) they must stop these for 2 weeks prior to enrollment on study.
Patients that already follow a whole foods plant based diet (ovo-lactovegetarian or processed junk food vegan diets are not excluded). This will be per research dietitian evaluation and discretion after nutrition screening.
Legume allergy
Severe allergies such as anaphylactic shock to peanuts and/or tree nuts, such as cashews
Concurrent participation in weight loss/dietary trials or defined programs (that require specified diets/supplements on the program). Patients on weight loss drugs are eligible.
Mental impairment leading to inability to cooperate
Enrollment onto any other therapeutic investigational study
Concurrent pregnancy
Patients on full dose anticoagulation
If in the opinion of the investigator there maybe any concerns regarding the ability of the patient to complete the study safely
Current self-reported heavy alcohol use and is defined as \>5 drinks per day or \>15 drinks per week
Current self-reported illicit drug use (except inhaled marijuana, vaping or cigarette smoking or medical marijuana.
Has a condition requiring antibiotics within 14 days of study intervention administration.
Plan for travel during the study that would preclude adherence to prescribed diets
History of active inflammatory bowel disease or major gastrointestinal surgery (not including appendectomy or cholecystectomy) within 3 months of enrollment or any history of total colectomy, or bariatric surgery (bariatric surgery which does not disrupt the gastrointestinal lumen, i.e. restrictive procedures such as banding, are permitted)

Interventions

DIETARY_SUPPLEMENTOmega-3

For 2 weeks, patients will receive omega 3 fatty acid supplements 1640 mg (2 capsules) twice daily

DIETARY_SUPPLEMENTCurcumin

For 2 weeks, patients in the curcumin arm will receive Curcumin C3 complex 1000 mg with 5 mg BioPerine twice daily

DIETARY_SUPPLEMENTProbiotic

For 2 weeks, patients in the probiotic arm will receive Ultra-50 probiotics with 50 billion CFU per capsule (one capsule) twice daily

OTHERWhole food, plant-based diet (WFPBD)

Daily Harvest once a week. The meals will have range from 2 breakfast, 11 lunch/dinners, 1 snack (provided Week 1), and whole grains items (provided Week 2).