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NCT Number: NCT05640843

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)

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.

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

Emory University (Data Collection Only), Atlanta, Georgia, United States

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Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Whole Foods Plant-based Diet

Other

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

Dietary Supplement

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

Placebo supplements

Other

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 outcomes

  1. 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

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

  • Daily Harvest
  • M and M labs
  • Paula and Rodger Riney Foundation
  • Plantable
  • Sabinsa pharmaceuticals
  • VeggieDoctor

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Dec 7, 2022
Registry last updated
Apr 16, 2026

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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