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Plant-Based Diet + Supplements for Multiple Myeloma

N/A

Recruiting

Led By Urvi Shah, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 years

Be older than 18 years old

Must not have

Mental impairment leading to inability to cooperate

Patients on full dose anticoagulation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 1 week

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at how dietary changes affect butyrate levels in people with SMM. Participants switch to plant-based diet/supplements (omega-3, curcumin, probiotics) for 2 wks to measure impact.

Who is the study for?

This trial is for adults over 18 with smoldering multiple myeloma who are willing to follow a plant-based diet or take dietary supplements. They must be able to prepare meals, send stool samples, and use the Keenoa app. Exclusions include those on certain medications, following a whole foods plant-based diet already, with severe allergies or gastrointestinal issues, heavy alcohol or illicit drug users.

What is being tested?

The study tests how a whole food plant-based diet and supplements like Omega-3, Curcumin, and Probiotics affect butyrate levels in stool of people with smoldering multiple myeloma over two weeks. Participants will document their experience using an app.

What are the potential side effects?

Potential side effects from the interventions may include digestive changes due to new diets or supplements. Specific side effects related to each supplement (Omega-3s might cause fishy burps; Curcumin could lead to stomach upset; Probiotics may result in gas/bloating) can vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am mentally capable of following study procedures.

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I am on a full dose of blood thinners.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 1 week

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 1 week

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 week for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Relative abundance of stool butyrate producers at 2 weeks

Secondary study objectives

Adherence

evaluate the change in Butyrate levels

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Whole food, plant-based diet (WFPBD)Experimental Treatment1 Intervention

For 2 weeks, on the WFPBD arm, patients will receive 14 items weekly, prepared and shipped by U.S. based company, 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). The meals will contain legumes, fruits, vegetables, whole grains, and plant-based fats that have undergone minimal processing. Detailed recommendations for additional meals outside those given by Daily Harvet meeting the standard of a WFPBD will also be given to supplement their individual daily calorie needs through the guidance of the research dietitian. Patients will receive a varied menu created by Daily Harvest and the study team on a weekly basis.

Group II: ProbioticExperimental Treatment1 Intervention

For 2 weeks, patients in the probiotic arm will receive Ultra-50 probiotics with 50 billion CFU per capsule (one capsule) twice daily from Vita Miracle pharmaceuticals. No dietary changes will be made but data on dietary intake will be collected.

Group III: Omega-3Experimental Treatment1 Intervention

For 2 weeks, patients will receive omega 3 fatty acid supplements 1640 mg (2 capsules) twice daily Qwell™ Omega 3 by The Veggie Doctor™. Each 820 mg omega 3 supplement capsule contains 700 mg Docosohexaenoic acid, 100 mg Docosapentaenoic acid, and 20 mg Eicosapentaenoic acid. No dietary changes will be made but data on dietary intake will be collected.

Group IV: CurcuminExperimental Treatment1 Intervention

For 2 weeks, patients in the curcumin arm will receive Curcumin C3 complex 1000 mg with 5 mg BioPerine twice daily from Sabinsa pharmaceuticals. No dietary changes will be made but data on dietary intake will be collected.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Curcumin

2017

Completed Phase 4

~1070

Probiotic

2013

Completed Phase 4

~3570