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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Omega-3

    Dietary supplement

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

  • Curcumin

    Dietary supplement

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

  • Probiotic

    Dietary supplement

    For 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 intervention

    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).

Treatment groups

200 Participants
are divided into 4 treatment groups
Group A: Omega-3Experimental treatment 1 intervention
Group B: CurcuminExperimental treatment 1 intervention
Group C: ProbioticExperimental treatment 1 intervention
Group D: Whole food, plant-based diet (WFPBD)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
at 2 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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