About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Omega-3
Dietary supplementFor 2 weeks, patients will receive omega 3 fatty acid supplements 1640 mg (2 capsules) twice daily
Curcumin
Dietary supplementFor 2 weeks, patients in the curcumin arm will receive Curcumin C3 complex 1000 mg with 5 mg BioPerine twice daily
Probiotic
Dietary supplementFor 2 weeks, patients in the probiotic arm will receive Ultra-50 probiotics with 50 billion CFU per capsule (one capsule) twice daily
Whole food, plant-based diet (WFPBD)
Other interventionDaily 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).
Treatment groups
Trial outcomes
Primary outcomes
Relative abundance of stool butyrate producers 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.
Sponsors and contacts
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Memorial Sloan Kettering Cancer Center
Lead sponsor
HealthTree Foundation
Collaborator