NCT06055894Recruiting
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
Source: ClinicalTrials.gov · Last updated 5 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 20 Sept 2023
- Start date
- 20 Sept 2023
- Primary completion date
- Sept 2027
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Diseases
- Multiple myeloma
- NCT number
- NCT06055894
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 20 Sept 2023 to the primary completion date, Sept 2027
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent participation in weight loss/dietary trials or defined programs (that require specified diets/supplements on the program). Patients on weight loss drugs are eligible.
- Concurrent pregnancy
- Current self-reported illicit drug use (except inhaled marijuana, vaping or cigarette smoking or medical marijuana.
Other illness
- Legume allergy
- Severe allergies such as anaphylactic shock to peanuts and/or tree nuts, such as cashews
- Mental impairment leading to inability to cooperate
- Has a condition requiring antibiotics within 14 days of study intervention administration.
- History of active inflammatory bowel disease or major gastrointestinal surgery (not including appendectomy or cholecystectomy) within 3 months of enrollment or any history of total colectomy, or bariatric surgery (bariatric surgery which does not disrupt the gastrointestinal lumen, i.e. restrictive procedures such as banding, are permitted)
Lab values
- 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.
Other
- 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.
- Enrollment onto any other therapeutic investigational study
- Patients on full dose anticoagulation
- If in the opinion of the investigator there maybe any concerns regarding the ability of the patient to complete the study safely
- Current self-reported heavy alcohol use and is defined as \>5 drinks per day or \>15 drinks per week
- Plan for travel during the study that would preclude adherence to prescribed diets
Who the study is looking for
- 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)
- Interested in learning to cook plant-based recipes
- Access to smart mobile phone or device with camera and ability to download Keenoa app
- Be residing within the United States for the study duration.
- English speaking or a family member or caregiver who speaks English and is able to assist with the surveys and phone based Keenoa app.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge (All Protocol Activities) Coordinator of this site? Confirm its status | Basking Ridge | United States | Recruiting |
| Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) Coordinator of this site? Confirm its status | Commack | United States | Recruiting |
| Memorial Sloan Kettering Westchester (All Protocol Activities) Coordinator of this site? Confirm its status | Harrison | United States | Recruiting |
| Memorial Sloan Kettering Monmouth (All Protocol Activities) Coordinator of this site? Confirm its status | Middletown | United States | Recruiting |
| Memorial Sloan Kettering Bergen (All Protocol Activities) Coordinator of this site? Confirm its status | Montvale | United States | Recruiting |
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Memorial Sloan Kettering Nassau (All Protocol Activities) Coordinator of this site? Confirm its status | Uniondale | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.