Monoclonal Gammopathy of Undetermined SignificanceNCT05640843
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 study testing Whole Foods Plant-based Diet and Algae Omega 3 + Curcumin in people with Monoclonal Gammopathy of Undetermined Significance and Smoldering Multiple Myeloma, run by Memorial Sloan Kettering Cancer Center at 8 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Monoclonal Gammopathy of Undetermined Significance, Smoldering Multiple Myeloma
- What is being tested?
- Whole Foods Plant-based Diet and Algae Omega 3 + Curcumin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 8 sitesUnited States
- Study dates
- 29 Nov 2022to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Willingness to comply with all study-related procedures
- ECOG performance status of 0-3
- Interested in learning to cook plant based recipes
Who cannot join
- 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
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- 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.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Alexander Lesokhin, MD contact
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
Emory University (Data Collection Only)
Atlanta, Georgia, 30322
Nisha Joseph, MD, 404-778-0519
- Recruiting
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920
Urvi A Shah, MD, MS, 646-608-3713
- Recruiting
Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)
Commack, New York, 11725
Urvi A Shah, MD, MS, 646-608-3713
- Recruiting
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604
Urvi A Shah, MD, MS, 646-608-3713
- Recruiting
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748
Urvi A Shah, MD, MS, 646-608-3713
- Recruiting
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, 07645
Urvi A Shah, MD, MS, 646-608-3713
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Urvi A Shah, MD, MS, 646-608-3713
- Recruiting
Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York, 11553
Urvi A Shah, MD, MS, 646-608-3713
About this study
Official title: 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
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.
- Being tested
- Whole Foods Plant-based Diet, Algae Omega 3 + Curcumin, Placebo supplements
- Keywords
- Plant-Based Diet, Supplements, 22-175
- Medical subject headings
- Monoclonal Gammopathy of Undetermined Significance, Smoldering Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Foods Plant-based DietOther
The meals will have a low glycemic index and contain legumes, vegetables, whole grains, and plant-based fats that have undergone minimal processing. Detailed recommendations for snacks and breakfasts meeting the standard of a WFPBD will also be given to supplement their daily calorie needs with access to education materials. Patients will also receive dietary education and counselling from a research dietitian every 4 weeks for the 12-week intervention period. They will have access to the team for questions and support as needed
Algae Omega 3 + CurcuminDietary supplement
For 52 weeks on the supplement arm, patients will be given algae omega 3 supplements and curcumin supplements (Sabinsa pharmaceuticals) twice daily
Placebo supplementsOther
For 25 weeks on the placebo arm, patients will be given placebo supplements twice daily (Veggie Doctor/M and M pharmaceuticals and Sabinsa pharmaceuticals).
| Study group | Role | What they receive |
|---|---|---|
| Daily Harvest weekly | Experimental | 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. Receives: Other: Whole Foods Plant-based Diet |
| Supplements | Experimental | For 12 weeks on the supplement arm, patients will be given algae omega 3 supplements (QWell pharmaceuticals) and curcumin supplements (Sabinsa pharmaceuticals) twice daily. Receives: Dietary Supplement: Algae Omega 3 + Curcumin |
| Placebo | Placebo comparator | For 12 weeks on the placebo arm, patients will be given placebo supplements twice daily (QWell and Sabinsa pharmaceuticals). Receives: Other: Placebo supplements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool microbiome diversity at 12 weeks
To evaluate the change in stool microbiome diversity on a dietary vs supplement vs placebo intervention at 12 weeks when compared to baseline
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start29 Nov 2022
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Monoclonal Gammopathy of Undetermined SignificanceStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, multi-center pilot study with 150 patients (50 per arm). Randomization will be stratified based on BMI and MGUS/SMM status. Randomization in the supplement and placebo arms will be blinded.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Paula and Rodger Riney Foundation, Plantable, M and M labs, VeggieDoctor, Sabinsa pharmaceuticals, Daily Harvest
- Responsible party
- Sponsor
- Investigators
- Urvi A Shah, MD, MS, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05640843
- Sponsor's protocol ID
- 22-175
- Status last verified
- Apr 2026
- First submitted
- 29 Nov 2022
- Last updated
- 16 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05640843
- Acronym / sponsor ID
- 22-175
- Keywords
- Plant-Based Diet, Supplements, 22-175
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Paula and Rodger Riney Foundation, Plantable, M and M labs, VeggieDoctor, Sabinsa pharmaceuticals, Daily Harvest
- Study start
- 29 Nov 2022 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 7 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- This is a randomized, multi-center pilot study with 150 patients (50 per arm). Randomization will be stratified based on BMI and MGUS/SMM status. Randomization in the supplement and placebo arms will be blinded.
| Arm | Type | Receives |
|---|---|---|
| Daily Harvest weekly | Experimental | Other: Whole Foods Plant-based DietFor 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. |
| Supplements | Experimental | Dietary Supplement: Algae Omega 3 + CurcuminFor 12 weeks on the supplement arm, patients will be given algae omega 3 supplements (QWell pharmaceuticals) and curcumin supplements (Sabinsa pharmaceuticals) twice daily. |
| Placebo | Placebo comparator | Other: Placebo supplementsFor 12 weeks on the placebo arm, patients will be given placebo supplements twice daily (QWell and Sabinsa pharmaceuticals). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole Foods Plant-based DietThe meals will have a low glycemic index and contain legumes, vegetables, whole grains, and plant-based fats that have undergone minimal processing. Detailed recommendations for snacks and breakfasts meeting the standard of a WFPBD will also be given to supplement their daily calorie needs with access to education materials. Patients will also receive dietary education and counselling from a research dietitian every 4 weeks for the 12-week intervention period. They will have access to the team for questions and support as needed | Other | Daily Harvest weekly |
| Algae Omega 3 + CurcuminFor 52 weeks on the supplement arm, patients will be given algae omega 3 supplements and curcumin supplements (Sabinsa pharmaceuticals) twice daily | Dietary supplement | Supplements |
| Placebo supplementsFor 25 weeks on the placebo arm, patients will be given placebo supplements twice daily (Veggie Doctor/M and M pharmaceuticals and Sabinsa pharmaceuticals). | Other | Placebo |
Primary outcome
Stool microbiome diversity at 12 weeks
Time frame: 12 weeks
To evaluate the change in stool microbiome diversity on a dietary vs supplement vs placebo intervention at 12 weeks when compared to baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexander Lesokhin, MD contact
Urvi A Shah, MD, MS principal investigator
Memorial Sloan Kettering Cancer Center
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole Foods Plant-based Diet and Algae Omega 3 + Curcumin in people with Monoclonal Gammopathy of Undetermined Significance and Smoldering Multiple Myeloma, run by Memorial Sloan Kettering Cancer Center at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Urvi A Shah, MD, MS (646-608-3713, ShahNutrivention@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stool microbiome diversity at 12 weeks (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026; AzTrials last refreshed its copy on 27 Oct 2026.