Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Monoclonal Gammopathy of Undetermined Significance | Monoclonal Gammopathy of Undetermined Significance | ONTOLOGY_EXACT | 0.98 |
| Smoldering Multiple Myeloma | Smoldering Multiple Myeloma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Algae Omega 3 + Curcumin | Dietary Supplement | — | UNRESOLVED |
| Placebo supplements | Other | — | UNRESOLVED |
| Whole Foods Plant-based Diet | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Daily Harvest weekly
- description
- For 12 weeks, on the Daily Harvest weekly arm, patients will receive two premade meals per day, for lunch and dinner for 6 days weekly, prepared and shipped by U.S.-based company Daily Harvest weekly.
- interventionNames
- Other: Whole Foods Plant-based Diet
- type
- EXPERIMENTAL
- label
- Supplements
- description
- For 12 weeks on the supplement arm, patients will be given algae omega 3 supplements (QWell pharmaceuticals) and curcumin supplements (Sabinsa pharmaceuticals) twice daily.
- interventionNames
- Dietary Supplement: Algae Omega 3 + Curcumin
- type
- PLACEBO_COMPARATOR
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Patients that already follow a whole foods plant based diet (ovo-lacto-vegetarian or processed junk food vegan diets are not excluded) * Legume allergy * Severe allergies such as anaphylactic shock to nuts (specifically cashews). Peanuts are not included in the meals. * Concurrent participation in weight loss/dietary/exercise programs * Mental impairment leading to inability to cooperate * Enrollment onto any other therapeutic investigational study concurrently and up to 180 days prior to study start date * Concurrent pregnancy * Positive HBV, HCV or HIV PCR test will need to be treated first and once undetectable viral load patients may enroll * ≥ 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) * Current self-reported illicit drug use (eg heroin, cocaine not marijuana) * Plan for prolonged travel during the study that would preclude adherence to prescribed diets * History of major gastrointestinal surgery (not including appendectomy or cholecystectomy) within 3 months of enrollment * If already taking curcumin or omega 3 supplements patients must be willing to stop it on the date of trial consent for study duration.
References
Publications (0)
Data not yet available