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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 1 week

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am 18 years old or older.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Adherence

evaluate the change in Butyrate levels

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

~1050

Omega-3

2012

Completed Phase 4

~1760

Probiotic

2013

Completed Phase 4

~3570

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,798 Total Patients Enrolled

80 Trials studying Multiple Myeloma

86,067 Patients Enrolled for Multiple Myeloma

HealthTree FoundationOTHER

1 Previous Clinical Trials

1,500 Total Patients Enrolled

1 Trials studying Multiple Myeloma

1,500 Patients Enrolled for Multiple Myeloma

Urvi Shah, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

3 Previous Clinical Trials

194 Total Patients Enrolled

3 Trials studying Multiple Myeloma

194 Patients Enrolled for Multiple Myeloma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there currently an opportunity for participants to join this clinical trial?

"Affirmative. According to the information from clinicaltrials.gov, this trial is actively accepting applicants and initially posted on September 20th 2019 with its most recent edit occurring at the same date. The study demands 100 patients be enrolled across 7 different medical centres."

Answered by AI

How many medical institutions are providing access to this clinical experiment?

"This trial is presently recruiting from a total of 7 sites, 4 of which are Middletown, Montvale and Commack. To reduce the amount of travelling required for this study, it is recommended to pick a medical center that's closest to you."

Answered by AI

What is the scope of participants in this clinical investigation?

"Affirmative. The details hosted on clinicaltrials.gov demonstrate that this research initiative is actively looking for subjects: the study was first posted on September 20th, 2023 and modified most recently on the same date. 100 participants are needed from 7 sites across the country."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of a Plant-Based Diet and Dietary Supplements in People With Smoldering Multiple Myeloma (SMM)

2023. "A Study of a Plant-Based Diet and Dietary Supplements in People With Smoldering Multiple Myeloma (SMM)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06055894.