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)

August 29, 2023 updated by: Memorial Sloan Kettering Cancer Center

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 (NUTRIVENTION3) 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Alexander Lesokhin, MD
  • Phone Number: 646-608-3717

Study Contact Backup

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Recruiting
        • Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
        • Contact:
          • Urvi Shah, MD
          • Phone Number: 646-608-3713
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • Memorial Sloan Kettering Monmouth (All protocol activities)
        • Contact:
          • Urvi Shah, MD
          • Phone Number: 646-608-3713
      • Montvale, New Jersey, United States, 07645
        • Recruiting
        • Memorial Sloan Kettering Bergen (All Protocol Activities)
        • Contact:
          • Urvi Shah, MD
          • Phone Number: 646-608-3713
    • New York
      • Commack, New York, United States, 11725
        • Recruiting
        • Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)
        • Contact:
          • Urvi Shah, MD
          • Phone Number: 646-608-3713
      • Harrison, New York, United States, 10604
        • Recruiting
        • Memorial Sloan Kettering Westchester (All Protocol Activities)
        • Contact:
          • Urvi Shah, MD
          • Phone Number: 646-608-3713
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
        • Contact:
          • Urvi Shah, MD
          • Phone Number: 646-608-3713
      • Uniondale, New York, United States, 11553
        • Recruiting
        • Memorial Sloan Kettering Nassau (All Protocol Activities)
        • Contact:
          • Urvi Shah, MD
          • Phone Number: 646-608-3713

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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
  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Whole Foods Plant-based Diet
For 12 weeks, on the WFPBD arm, patients will receive two premade meals per day, for lunch and dinner for 6 days weekly, prepared and shipped by U.S.-based WFPBD company Plantable weekly.
Other: Whole Foods Plant-based Diet

The meals will have a low glycemic index and contain 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 an online portal from Plantable which contains education materials and access to a health coach daily. 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
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.
Dietary supplement: Algae omega 3
Algae omega 3 given twice daily.
Placebo Comparator: Placebo
For 12 weeks on the placebo arm, patients will be given placebo supplements twice daily (QWell and Sabinsa pharmaceuticals).
Other: Placebo supplements
Placebo supplements given twice daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in stool butyrate levels
Time Frame: 12 weeks
change in stool butyrate levels on a dietary vs supplement vs placebo intervention at 12 weeks when compared to baseline
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Paula and Rodger Riney Foundation
Plantable
M and M labs
VeggieDoctor
Sabinsa pharmaceuticals

Investigators

  • Principal Investigator: Urvi Shah, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2022

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

November 29, 2022

First Submitted That Met QC Criteria

November 29, 2022

First Posted (Actual)

December 7, 2022

Study Record Updates

Last Update Posted (Actual)

August 30, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-175

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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