Actively Recruiting
A Study of a Plant-Based Diet and Dietary Supplements in People With Smoldering Multiple Myeloma (SMM) or Monoclonal Gammopathy of Undetermined Significance (MGUS)
Led by Memorial Sloan Kettering Cancer Center · Updated on 2025-11-13
200
Participants Needed
7
Research Sites
153 weeks
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
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
Official 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 prior diagnosis of MGUS or smoldering myeloma documented within 6 months prior to enrollment
- Age 18 years or older
- Willingness to follow all study procedures
- Physically able to complete study requirements or has assistance for tasks like meal preparation, stool shipment, and surveys
- Interest in learning to cook plant-based recipes
- Access to a smartphone or device with camera and ability to download the Keenoa app
- Residing in the United States for the study duration
- English speaking or has a family member/caregiver who can assist with surveys and app use
You will not qualify if you...
- Taking supplements other than vitamin D, iron, vitamin B12, potassium, magnesium, calcium, or medically required supplements unless approved by the principal investigator
- Currently following a whole foods plant-based diet (ovo-lactovegetarian or processed junk food vegan diets allowed)
- Allergy to legumes
- Severe allergies like anaphylaxis to peanuts or tree nuts such as cashews
- Participating in weight loss or dietary trials/programs requiring specific diets or supplements (weight loss drugs allowed)
- Mental impairment preventing cooperation
- Enrolled in any other therapeutic investigational study
- Currently pregnant
- Taking full dose anticoagulation
- Investigator concerns about ability to safely complete the study
- Heavy alcohol use defined as more than 5 drinks per day or more than 15 drinks per week
- Current illicit drug use except inhaled marijuana, vaping, cigarette smoking, or medical marijuana
- Requires antibiotics within 14 days before study intervention
- Plans to travel during the study that would prevent adherence
- History of active inflammatory bowel disease or major gastrointestinal surgery within 3 months prior to enrollment, or history of total colectomy or bariatric surgery (restrictive bariatric surgery allowed)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
A
Alexander Lesokhin, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here