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RecruitingNCT06055894

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

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

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
200 (estimated)
Sponsor
Memorial Sloan Kettering Cancer Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTOmega-3For 2 weeks, patients will receive omega 3 fatty acid supplements 1640 mg (2 capsules) twice daily
DIETARY_SUPPLEMENTCurcuminFor 2 weeks, patients in the curcumin arm will receive Curcumin C3 complex 1000 mg with 5 mg BioPerine twice daily
DIETARY_SUPPLEMENTProbioticFor 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).

Timeline

Start date
2023-09-20
Primary completion
2026-09-01
Completion
2026-09-01
First posted
2023-09-28
Last updated
2025-11-13

Locations

7 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT06055894. Inclusion in this directory is not an endorsement.