search
Back to results

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

Primary Purpose

Multiple Myeloma, Smoldering

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Omega-3
Curcumin
Probiotic
Whole food, plant-based diet (WFPBD)
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Multiple Myeloma, Smoldering focused on measuring Plant-Based Diet, Dietary Supplements, 23-116

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Confirmed prior diagnosis of smoldering myeloma (anytime prior). However, confirmation of SMM diagnosis must be documented in their last local oncologist clinic note within 3 months prior to study enrollment. Age ≥18 years Willingness to comply with all study-related procedures Physically able to complete requirements for the study or has someone to assist with the requirements (such as meal preparation, stool shipment and survey completion) Interested in learning to cook plant based recipes Access to smart mobile phone or device with camera and ability to download Keenoa app Be residing within the United States for the study duration. English speaking or a family member or caregiver who speaks English and is able to assist with the surveys and phone based Keenoa app. Exclusion Criteria: Taking any supplements other than vitamin D, iron, vitamin B12, potassium, magnesium, calcium or those needed for a medical indication must be reviewed by PI. If patient is on a supplement (including curcumin, probiotic, omega3) they must stop these for 2 weeks prior to enrollment on study. Patients that already follow a whole foods plant based diet (ovo-lactovegetarian or processed junk food vegan diets are not excluded). This will be per research dietitian evaluation and discretion after nutrition screening. Legume allergy Severe allergies such as anaphylactic shock to peanuts and/or tree nuts, such as cashews Concurrent participation in weight loss/dietary trials or defined programs (that require specified diets/supplements on the program) Mental impairment leading to inability to cooperate Enrollment onto any other therapeutic investigational study Concurrent pregnancy Patients on full dose anticoagulation ≥ Grade 2 electrolyte (sodium and potassium) 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 Current self reported heavy alcohol use (defined as >2 drinks per day or >14 drinks per week) Current self-reported illicit drug use (except inhaled marijuana, vaping or cigarette smoking. Oral marijuana/THC excluded or must stop >2 weeks prior.) Has a condition requiring antibiotics within 14 days of study intervention administration. Plan for travel during the study that would preclude adherence to prescribed diets History of active inflammatory bowel disease or major gastrointestinal surgery (not including appendectomy or cholecystectomy) within 3 months of enrollment or any history of total colectomy, or bariatric surgery (bariatric surgery which does not disrupt the gastrointestinal lumen, i.e. restrictive procedures such as banding, are permitted)

Sites / Locations

  • Memorial Sloan Kettering Basking Ridge (All Protocol Activities)Recruiting
  • Memorial Sloan Kettering Monmouth (All Protocol Activities)Recruiting
  • Memorial Sloan Kettering Bergen (All Protocol Activities)Recruiting
  • Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)Recruiting
  • Memorial Sloan Kettering Westchester (All Protocol Activities)Recruiting
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)Recruiting
  • Memorial Sloan Kettering Nassau (All Protocol Activities)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Omega-3

Curcumin

Probiotic

Whole food, plant-based diet (WFPBD)

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

evaluate the change in Butyrate levels
To evaluate the change in stool butyrate levels, which is defined as the average of -1 and 0 week samples. Patient stool will be assessed for butyrate levels in batches by gas chromatography mass spectrometry.

Secondary Outcome Measures

evaluate the change in Butyrate levels
To evaluate the change in stool butyrate levels which is defined as the average of -1 and 0 week samples. Patient stool will be assessed for butyrate levels in batches by gas chromatography mass spectrometry.
Adherence
To evaluate the dietary or supplement compliance at 2 weeks. ≥ 70% of meals or pills during the 2-week intervention period, by ASA dietary recalls at each visit and pill diaries.

Full Information

First Posted
September 20, 2023
Last Updated
October 1, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
HealthTree Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT06055894
Brief Title
A Study of a Plant-Based Diet and Dietary Supplements in People With Smoldering Multiple Myeloma (SMM)
Official Title
Microbial Changes in Response to a Plant Based Diet and/or Supplements in SMM Patients: A National Multi-Arm Randomized Prospective Telehealth Study Via HealthTree
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 20, 2023 (Actual)
Primary Completion Date
September 2026 (Anticipated)
Study Completion Date
September 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
HealthTree Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to look at how butyrate levels change in participants' stool after they are on a plant-based diet or dietary supplements (omega-3, curcumin or probiotics) for 2 weeks. All participants will have smoldering multiple myeloma (SMM). The researchers will compare how the different dietary changes affect butyrate levels in participants' stool.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma, Smoldering
Keywords
Plant-Based Diet, Dietary Supplements, 23-116

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a randomized, non blinded, telehealth based, national pilot study with 100 patients (25 per arm). Randomization will be stratified based on BMI (normal/elevated) and Mayo risk SMM criteria.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Omega-3
Arm Type
Experimental
Arm Description
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.
Arm Title
Curcumin
Arm Type
Experimental
Arm Description
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.
Arm Title
Probiotic
Arm Type
Experimental
Arm Description
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.
Arm Title
Whole food, plant-based diet (WFPBD)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3
Intervention Description
For 2 weeks, patients will receive omega 3 fatty acid supplements 1640 mg (2 capsules) twice daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Curcumin
Intervention Description
For 2 weeks, patients in the curcumin arm will receive Curcumin C3 complex 1000 mg with 5 mg BioPerine twice daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic
Intervention Description
For 2 weeks, patients in the probiotic arm will receive Ultra-50 probiotics with 50 billion CFU per capsule (one capsule) twice daily
Intervention Type
Other
Intervention Name(s)
Whole food, plant-based diet (WFPBD)
Intervention Description
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).
Primary Outcome Measure Information:
Title
evaluate the change in Butyrate levels
Description
To evaluate the change in stool butyrate levels, which is defined as the average of -1 and 0 week samples. Patient stool will be assessed for butyrate levels in batches by gas chromatography mass spectrometry.
Time Frame
at 2 weeks
Secondary Outcome Measure Information:
Title
evaluate the change in Butyrate levels
Description
To evaluate the change in stool butyrate levels which is defined as the average of -1 and 0 week samples. Patient stool will be assessed for butyrate levels in batches by gas chromatography mass spectrometry.
Time Frame
at 1 week
Title
Adherence
Description
To evaluate the dietary or supplement compliance at 2 weeks. ≥ 70% of meals or pills during the 2-week intervention period, by ASA dietary recalls at each visit and pill diaries.
Time Frame
at 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Confirmed prior diagnosis of smoldering myeloma (anytime prior). However, confirmation of SMM diagnosis must be documented in their last local oncologist clinic note within 3 months prior to study enrollment. Age ≥18 years Willingness to comply with all study-related procedures Physically able to complete requirements for the study or has someone to assist with the requirements (such as meal preparation, stool shipment and survey completion) Interested in learning to cook plant based recipes Access to smart mobile phone or device with camera and ability to download Keenoa app Be residing within the United States for the study duration. English speaking or a family member or caregiver who speaks English and is able to assist with the surveys and phone based Keenoa app. Exclusion Criteria: Taking any supplements other than vitamin D, iron, vitamin B12, potassium, magnesium, calcium or those needed for a medical indication must be reviewed by PI. If patient is on a supplement (including curcumin, probiotic, omega3) they must stop these for 2 weeks prior to enrollment on study. Patients that already follow a whole foods plant based diet (ovo-lactovegetarian or processed junk food vegan diets are not excluded). This will be per research dietitian evaluation and discretion after nutrition screening. Legume allergy Severe allergies such as anaphylactic shock to peanuts and/or tree nuts, such as cashews Concurrent participation in weight loss/dietary trials or defined programs (that require specified diets/supplements on the program) Mental impairment leading to inability to cooperate Enrollment onto any other therapeutic investigational study Concurrent pregnancy Patients on full dose anticoagulation ≥ Grade 2 electrolyte (sodium and potassium) 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 Current self reported heavy alcohol use (defined as >2 drinks per day or >14 drinks per week) Current self-reported illicit drug use (except inhaled marijuana, vaping or cigarette smoking. Oral marijuana/THC excluded or must stop >2 weeks prior.) Has a condition requiring antibiotics within 14 days of study intervention administration. Plan for travel during the study that would preclude adherence to prescribed diets History of active inflammatory bowel disease or major gastrointestinal surgery (not including appendectomy or cholecystectomy) within 3 months of enrollment or any history of total colectomy, or bariatric surgery (bariatric surgery which does not disrupt the gastrointestinal lumen, i.e. restrictive procedures such as banding, are permitted)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Urvi Shah, MD
Phone
646-608-3713
Email
shahu@mskcc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Lesokhin, MD
Phone
646-608-3717
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Urvi Shah, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Urvi Shah, MD
Phone
646-608-3713
Facility Name
Memorial Sloan Kettering Monmouth (All Protocol Activities)
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Urvi Shah, MD
Phone
646-608-3713
Facility Name
Memorial Sloan Kettering Bergen (All Protocol Activities)
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Urvi Shah, MD
Phone
646-608-3713
Facility Name
Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Urvi Shah, MD
Phone
646-608-3713
Facility Name
Memorial Sloan Kettering Westchester (All Protocol Activities)
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Urvi Shah, MD
Phone
646-608-3713
Facility Name
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Urvi Shah, MD
Phone
646-608-3713
Facility Name
Memorial Sloan Kettering Nassau (All Protocol Activities)
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Urvi Shah, MD
Phone
646-608-3713

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

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

We'll reach out to this number within 24 hrs