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

Official title

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

Overview

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.

Interventions

• Dietary supplement Omega-3
  For 2 weeks, patients will receive omega 3 fatty acid supplements 1640 mg (2 capsules) twice daily
• Dietary supplement Curcumin
  For 2 weeks, patients in the curcumin arm will receive Curcumin C3 complex 1000 mg with 5 mg BioPerine twice daily
• Dietary supplement Probiotic
  For 2 weeks, patients in the probiotic arm will receive Ultra-50 probiotics with 50 billion CFU per capsule (one capsule) twice daily
• Other Whole 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).

Primary outcome measures

• Relative abundance of stool butyrate producers at 2 weeks [Time frame: at 2 weeks]

Eligibility criteria

Inclusion criteria

• 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 criteria

• 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)

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

Open label

Primary purpose

Prevention

Study locations

United States · 7 centers

• 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 (Limited 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: NCT06055894 · 23-116

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗