Recruiting

Plant-Based Diet

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT05640843

Conditions

Monoclonal Gammopathy of Undetermined Significance

Smoldering Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Whole Foods Plant-based Diet

Algae Omega 3 + Curcumin

Placebo supplements

Study Details

Brief 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). 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

Monoclonal Gammopathy of Undetermined Significance

Smoldering Multiple Myeloma

Study ID

NCT05640843

Start date

Nov 29, 2022

Status verified date

Apr, 2026

Completion date

Nov, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Daily Harvest weekly

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.

experimental: Supplements

For 12 weeks on the supplement arm, patients will be given algae omega 3 supplements (QWell pharmaceuticals) and curcumin supplements (Sabinsa pharmaceuticals) twice daily.

placebo comparator: Placebo

For 12 weeks on the placebo arm, patients will be given placebo supplements twice daily (QWell and Sabinsa pharmaceuticals).

Interventions

Whole Foods Plant-based Diet

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 + Curcumin

For 52 weeks on the supplement arm, patients will be given algae omega 3 supplements and curcumin supplements (Sabinsa pharmaceuticals) twice daily

Placebo supplements

For 25 weeks on the placebo arm, patients will be given placebo supplements twice daily (Veggie Doctor/M and M pharmaceuticals and Sabinsa pharmaceuticals).

Primary outcome measure

  • Stool microbiome diversity at 12 weeks [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Urvi A Shah, MD, MS

646-608-3713ShahNutrivention@mskcc.org

Alexander Lesokhin, MD

646-608-3717

Locations

Emory University (Data Collection Only)

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Nisha Joseph, MD

404-778-0519

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Urvi A Shah, MD, MS

646-608-3713

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Urvi A Shah, MD, MS

646-608-3713

Memorial Sloan Kettering Bergen (All Protocol Activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Urvi A Shah, MD, MS

646-608-3713

Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)

Recruiting

Commack, New York, United States, 11725

Contacts

Urvi A Shah, MD, MS

646-608-3713

Memorial Sloan Kettering Westchester (All Protocol Activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Urvi A Shah, MD, MS

646-608-3713

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Recruiting

New York, New York, United States, 10065

Contacts

Urvi A Shah, MD, MS

646-608-3713

Memorial Sloan Kettering Nassau (All Protocol Activities)

Recruiting

Uniondale, New York, United States, 11553

Contacts

Urvi A Shah, MD, MS

646-608-3713

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Apr 16, 2026

Last verified

Apr, 2026

Keywords

  • Plant-Based Diet
  • Supplements
  • 22-175

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-04-16.