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

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Other, Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Georgia
Emory University (Data Collection Only)
RECRUITING
Atlanta
New Jersey
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
RECRUITING
Basking Ridge
Memorial Sloan Kettering Monmouth (All Protocol Activities)
RECRUITING
Middletown
Memorial Sloan Kettering Bergen (All Protocol Activities)
RECRUITING
Montvale
New York
Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)
RECRUITING
Commack
Memorial Sloan Kettering Westchester (All Protocol Activities)
RECRUITING
Harrison
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
RECRUITING
New York
Memorial Sloan Kettering Nassau (All Protocol Activities)
RECRUITING
Uniondale
Contact Information
Primary
Urvi A Shah, MD, MS
shahu@mskcc.org
646-608-3713
Backup
Alexander Lesokhin, MD
646-608-3717
Time Frame
Start Date: 2022-11-29
Estimated Completion Date: 2026-11
Participants
Target number of participants: 150
Treatments
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).
Sponsors
Collaborators: Plantable, M and M labs, Paula and Rodger Riney Foundation, Sabinsa pharmaceuticals, VeggieDoctor
Leads: Memorial Sloan Kettering Cancer Center

This content was sourced from clinicaltrials.gov