Clinical trial NCT06055894: 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/MGUS Patients: A National Multi-Arm Randomized Prospective Telehealth Study Via HealthTree
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Myeloma, Smoldering
Keywords: Plant-Based Diet
Dietary Supplements
23-116
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: HealthTree Foundation
First posted: 2023-09-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* Confirmed prior diagnosis MGUS or of smoldering myeloma (anytime prior). However, confirmation of diagnosis must be documented in their last local oncologist clinic note within 6 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)
* Concurrent use of prescription weight loss (such as semaglutides and tirzepatides) and/or therapeutic myeloma drugs such as daratumumab, lenalidomide, etc.) within 12 weeks of consent
* 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)

Primary outcomes:
measure: Relative abundance of stool butyrate producers at 2 weeks
timeFrame: at 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (All Protocol Activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (All Protocol Activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (All Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (All Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Urvi A Shah, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: