A Study of a Plant-Based Diet and Dietary Supplements in People With Smoldering Multiple Myeloma (SMM) or Monoclonal Gammopathy of Undetermined Significance (MGUS)
NCT06055894 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2025-11-13
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.
Conditions
- Multiple Myeloma, Smoldering
- Multiple Myeloma
- Monoclonal Gammopathy of Undetermined Significance
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).
Sponsors & Collaborators
-
HealthTree Foundation
collaborator OTHER -
Memorial Sloan Kettering Cancer Center
lead OTHER
Principal Investigators
-
Urvi A Shah, MD, MS · Memorial Sloan Kettering Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-09-20
- Primary Completion
- 2026-09-30
- Completion
- 2026-09-30
Countries
- United States
Study Locations
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