Monoclonal Gammopathy of Undetermined Significance, Multiple Myeloma, Multiple Myeloma, Smoldering
Conditions
Keywords
Plant-Based Diet, Dietary Supplements, 23-116
Brief 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.
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).
Sponsors
HealthTree Foundation
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
This is a randomized, non blinded, telehealth based, national pilot study with 100 patients (25 per arm). Randomization will be stratified based on BMI (normal/elevated) and Mayo risk SMM criteria.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative abundance of stool butyrate producers at 2 weeks | at 2 weeks | To evaluate the change in stool butyrate levels, which is defined as the average of -1 and 0 week samples. Patient stool will be assessed for butyrate levels in batches by gas chromatography mass spectrometry. |
Countries
United States
Contacts
Primary ContactUrvi A Shah, MD, MS
Backup ContactAlexander Lesokhin, MD
Outcome results
None listed