Actively Recruiting
Microbial Changes in Response to a Plant-Based Diet and Supplements in Patients with Smoldering Multiple Myeloma or MGUS: A National Randomized Telehealth Study
Led by Memorial Sloan Kettering Cancer Center · Updated on 2025-11-13
200
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
H
HealthTree Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how butyrate levels in stool change in people with smoldering multiple myeloma (SMM) or monoclonal gammopathy of undetermined significance (MGUS) after following a plant-based diet or taking dietary supplements. The study aims to compare the effects of different dietary changes on stool butyrate to better understand potential impacts on these conditions. Participants are randomly assigned to one of four groups for two weeks: omega-3 fatty acid supplements taken twice daily, curcumin supplements taken twice daily, probiotic supplements taken twice daily, or a whole food plant-based diet (WFPBD) provided through prepared meals and guided by a dietitian. No other dietary changes are made in the supplement groups, and dietary intake data is collected. During the study, participants will complete surveys and use a mobile app to track their diet and stool samples. Researchers will measure the relative abundance of butyrate-producing microbes in stool at two weeks. Participants must have access to a smartphone and live in the United States. The total participation lasts for the two-week intervention period, with monitoring of adherence and safety throughout.
CONDITIONS
Brief Title
A Study of a Plant-Based Diet and Dietary Supplements in People With Smoldering Multiple Myeloma (SMM) or Monoclonal Gammopathy of Undetermined Significance (MGUS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of MGUS or smoldering myeloma documented in a clinic note within 6 months prior to enrollment
- Age 18 years or older
- Willing to comply with all study procedures
- Physically able to complete study requirements or has assistance
- Interested in learning to cook plant-based recipes
- Has access to a smartphone or device with a camera and can use the Keenoa app
- Resides within the United States for the study duration
- English speaking or has a family member or caregiver who can assist with surveys and app usage
You will not qualify if you...
- Taking supplements other than vitamin D, iron, vitamin B12, potassium, magnesium, calcium unless reviewed and approved
- Must stop supplements like curcumin, probiotics, or omega-3 two weeks before enrollment
- Already following a whole foods plant-based diet (ovo-lactovegetarian or processed vegan diets allowed)
- Allergy to legumes
- Severe allergies such as anaphylactic shock to peanuts or tree nuts like cashews
- Participating in other weight loss or dietary trials requiring specific diets or supplements
- Mental impairment preventing cooperation
- Enrolled in other therapeutic investigational studies
- Currently pregnant
- On full dose anticoagulation
- Investigator concerns about safe study completion
- Heavy alcohol use (>5 drinks/day or >15 drinks/week)
- Illicit drug use except inhaled marijuana, vaping, cigarette smoking, or medical marijuana
- Need for antibiotics within 14 days before study intervention
- Planned travel during study that would prevent diet adherence
- History of active inflammatory bowel disease or major gastrointestinal surgery within 3 months
- History of total colectomy or bariatric surgery that disrupts the gastrointestinal tract (restrictive bariatric surgery allowed)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (telehealth)
Duration - 2 weeks
Participants receive dietary supplements or a plant-based diet intervention for 2 weeks. This includes omega-3 supplements, curcumin supplements, probiotic supplements, or weekly prepared plant-based meals along with dietary guidance.
Weekly visits via telehealth
Duration - Up to 2 weeks after treatment
Participants are monitored for changes in microbial composition after completing the 2-week intervention.
1 follow-up visit (telehealth)
Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
U
Urvi A Shah, MD, MS
A
Alexander Lesokhin, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
4
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