Whole Foods Plant-based Diet for Monoclonal Gammopathy of Undetermined Significance

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Monoclonal Gammopathy of Undetermined Significance+1 MoreAlgae omega 3 - DietarySupplement
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Monoclonal Gammopathy of Undetermined Significance
  • Multiple Myeloma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 12 weeks

12 weeks
Changes in stool butyrate levels

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

Whole Foods Plant-based Diet
1 of 3
Supplements
1 of 3
Placebo
1 of 3

Experimental Treatment

Non-Treatment Group

150 Total Participants · 3 Treatment Groups

Primary Treatment: Whole Foods Plant-based Diet · Has Placebo Group · N/A

Whole Foods Plant-based Diet
Other
Experimental Group · 1 Intervention: Whole Foods Plant-based Diet · Intervention Types: Other
Supplements
DietarySupplement
Experimental Group · 1 Intervention: Algae omega 3 · Intervention Types: DietarySupplement
Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo supplements · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 weeks

Who is running the clinical trial?

Sabinsa pharmaceuticalsUNKNOWN
Paula and Rodger Riney FoundationUNKNOWN
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,832 Previous Clinical Trials
584,258 Total Patients Enrolled
2 Trials studying Monoclonal Gammopathy of Undetermined Significance
80,781 Patients Enrolled for Monoclonal Gammopathy of Undetermined Significance
VeggieDoctorUNKNOWN
PlantableUNKNOWN
M and M labsUNKNOWN
Urvi Shah, MBBSPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
100 Total Patients Enrolled
Urvi Shah, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
2 Previous Clinical Trials
40 Total Patients Enrolled
1 Trials studying Monoclonal Gammopathy of Undetermined Significance
20 Patients Enrolled for Monoclonal Gammopathy of Undetermined Significance

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are interested in learning to cook plant based recipes.
You have been diagnosed with MGUS or SMM.
You have a non light chain MGUS/SMM with M spike ≥ 0.
You have light chain MGUS/SMM.

Who else is applying?

What state do they live in?
New York100.0%
What site did they apply to?
Memorial Sloan Kettering Westchester (All Protocol Activities)100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%