NCT05640843Recruiting
A Study Comparing a Plant-Based Diet With Supplements and Placebo in People With Monoclonal Gammopathy of Undetermined Significance (MGUS) or Smoldering Multiple Myeloma (SMM)
A Randomized Placebo Controlled Study of a Plant-Based Dietary Versus Supplement Versus Placebo Intervention in Patients With Monoclonal Gammopathy of Undetermined Significance (MGUS) and Smoldering Multiple Myeloma (SMM) - The Nutrition Prevention (NUTRIVENTION-3) Study
Source: ClinicalTrials.gov · Last updated 16 Apr 2026
Brief summary (registry, in English)
The researchers are doing this study to look at how butyrate levels change in participants' stool after they are on a- plant-based diet for at least 12 weeks. All participants will have monoclonal gammopathy of undetermined significance (MGUS) or smoldering multiple myeloma (SMM). We will compare how the plant-based diet, omega-3 fatty acid and curcumin supplements, and placebo (an inactive substance that looks like the study supplements) affect butyrate levels in participants' stool.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- First submitted
- 29 Nov 2022
- Start date
- 29 Nov 2022
- Primary completion date
- Nov 2026
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Diseases
- Multiple myeloma
- NCT number
- NCT05640843
What you commit to
- Study type: Interventional
- Planned participants: 180
- From 29 Nov 2022 to the primary completion date, Nov 2026
- 8 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/exercise programs
- Enrollment onto any other therapeutic investigational study concurrently and up to 180 days prior to study start date
- Concurrent pregnancy
- Current self-reported illicit drug use (eg heroin, cocaine not marijuana)
Other illness
- Legume allergy
- Severe allergies such as anaphylactic shock to nuts (specifically cashews). Peanuts are not included in the meals.
- Mental impairment leading to inability to cooperate
- Positive HBV, HCV or HIV PCR test will need to be treated first and once undetectable viral load patients may enroll
- History of major gastrointestinal surgery (not including appendectomy or cholecystectomy) within 3 months of enrollment
Other
- Patients that already follow a whole foods plant based diet (ovo-lacto-vegetarian or processed junk food vegan diets are not excluded)
- ≥ Grade 2 electrolyte abnormalities as defined by CTCAEv5.0 (need to be resolved before enrolling on study)
- If in the opinion of the investigator there maybe any concerns regarding the ability of the patient to complete the study safely or any contraindications
- Heavy drinker (defined as \>2 drinks per day or \>14 drinks per week)
- Plan for prolonged travel during the study that would preclude adherence to prescribed diets
- If already taking curcumin or omega 3 supplements patients must be willing to stop it on the date of trial consent for study duration.
Who the study is looking for
- Confirmed diagnosis of MGUS or SMM
- If non light chain MGUS/SMM then M spike must be either ≥ 0.2 g/dL or BM PC ≥10% (both not required)
- If light chain MGUS/SMM then involved must be ≥10 mg/dL or BM PC ≥10% (both not required)
- If IgA MGUS/SMM then an IgA level \>350 mg/dL and an abnormal immunofixation is required (M spike criteria not required).
- If IgD MGUS/SMM then an IgD level \>50 mg/dL and an abnormal immunofixation is required (M spike criteria not required).
- Age ≥18 years
- Willingness to comply with all study-related procedures
- ECOG performance status of 0-3
- Interested in learning to cook plant based recipes
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Emory University (Data Collection Only) Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| 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 (All 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.