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NCT Number: NCT06055894

A Study of a Plant-Based Diet and Dietary Supplements in People With Smoldering Multiple Myeloma (SMM) or Monoclonal Gammopathy of Undetermined Significance (MGUS)

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Sloan Kettering Basking Ridge (All Protocol Activities), Basking Ridge, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Omega-3

Dietary Supplement

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

Curcumin

Dietary Supplement

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

Probiotic

Dietary Supplement

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)

Other

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 outcomes

  1. Relative abundance of stool butyrate producers at 2 weeks

    Time frame: at 2 weeks

    To evaluate the change in stool butyrate levels, which is defined as the average of -1 and 0 week samples. Patient stool will be assessed for butyrate levels in batches by gas chromatography mass spectrometry.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexander Lesokhin, MD

CONTACT

646-608-3717

Urvi A Shah, MD, MS

CONTACT

[email protected]

646-608-3713

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • HealthTree Foundation

Registry information

Official study title

Microbial Changes in Response to a Plant Based Diet and/or Supplements in SMM/MGUS Patients: A National Multi-Arm Randomized Prospective Telehealth Study Via HealthTree

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 28, 2023
Registry last updated
Nov 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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