Recruiting

Plant-Based Diet

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT06055894

Conditions

Multiple Myeloma, Smoldering

Multiple Myeloma

Monoclonal Gammopathy of Undetermined Significance

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Omega-3

Curcumin

Probiotic

Whole food, plant-based diet (WFPBD)

Study Details

Brief summary:

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.

Conditions

Multiple Myeloma, Smoldering

Multiple Myeloma

Monoclonal Gammopathy of Undetermined Significance

Study ID

NCT06055894

Start date

Sep 20, 2023

Status verified date

Nov, 2025

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.
  • Legume allergy
  • Severe allergies such as anaphylactic shock to peanuts and/or tree nuts, such as cashews
  • 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.
  • Mental impairment leading to inability to cooperate
  • Enrollment onto any other therapeutic investigational study
  • Concurrent pregnancy
  • 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
  • Current self-reported illicit drug use (except inhaled marijuana, vaping or cigarette smoking or medical marijuana.
  • Has a condition requiring antibiotics within 14 days of study intervention administration.
  • Plan for travel during the study that would preclude adherence to prescribed diets
  • 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)

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Omega-3

For 2 weeks, patients will receive omega 3 fatty acid supplements 1640 mg (2 capsules) twice daily Qwell™ Omega 3 by The Veggie Doctor™. Each 820 mg omega 3 supplement capsule contains 700 mg Docosohexaenoic acid, 100 mg Docosapentaenoic acid, and 20 mg Eicosapentaenoic acid. No dietary changes will be made but data on dietary intake will be collected.

experimental: Curcumin

For 2 weeks, patients in the curcumin arm will receive Curcumin C3 complex 1000 mg with 5 mg BioPerine twice daily from Sabinsa pharmaceuticals. No dietary changes will be made but data on dietary intake will be collected.

experimental: Probiotic

For 2 weeks, patients in the probiotic arm will receive Ultra-50 probiotics with 50 billion CFU per capsule (one capsule) twice daily from Vita Miracle pharmaceuticals. No dietary changes will be made but data on dietary intake will be collected.

experimental: Whole food, plant-based diet (WFPBD)

For 2 weeks, on the WFPBD arm, patients will receive 14 items weekly, prepared and shipped by U.S. based company, Daily Harvest once a week. The meals will have range from 2 breakfast, 11 lunch/dinners, 1 snack (provided Week 1), and whole grains items (provided Week 2). The meals will contain legumes, fruits, vegetables, whole grains, and plant-based fats that have undergone minimal processing. Detailed recommendations for additional meals outside those given by Daily Harvet meeting the standard of a WFPBD will also be given to supplement their individual daily calorie needs through the guidance of the research dietitian. Patients will receive a varied menu created by Daily Harvest and the study team on a weekly basis.

Interventions

Omega-3

For 2 weeks, patients will receive omega 3 fatty acid supplements 1640 mg (2 capsules) twice daily

Curcumin

For 2 weeks, patients in the curcumin arm will receive Curcumin C3 complex 1000 mg with 5 mg BioPerine twice daily

Probiotic

For 2 weeks, patients in the probiotic arm will receive Ultra-50 probiotics with 50 billion CFU per capsule (one capsule) twice daily

Whole food, plant-based diet (WFPBD)

Daily Harvest once a week. The meals will have range from 2 breakfast, 11 lunch/dinners, 1 snack (provided Week 1), and whole grains items (provided Week 2).

Primary outcome measure

  • Relative abundance of stool butyrate producers at 2 weeks [ Time Frame: at 2 weeks ]

Central Contacts and Locations

Central contacts

Urvi A Shah, MD, MS

646-608-3713ShahNutrivention@mskcc.org

Alexander Lesokhin, MD

646-608-3717

Locations

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 (Limited Protocol Activities)

Recruiting

Commack, New York, United States, 11725

Contacts

Thomas Kaley, MD

212-639-5122

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

Nov 13, 2025

Last verified

Nov, 2025

Keywords

  • Plant-Based Diet
  • Dietary Supplements
  • 23-116

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-19. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2025-11-13.