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 SUPPLEMENTS OR PLANT-BASED DIET FOR SMM PATIENTS

What's the purpose of this trial?

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.

This trial is currently open and accepting patients.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

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)

Additional Trial Information

Pilot Trial

Enrollment: 100 patients (estimated)

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

New Jersey

Memorial Sloan Kettering Cancer Center

Basking Ridge, NJ

Open and Accepting

Memorial Sloan Kettering Cancer Center

Middletown, NJ

Open and Accepting

Memorial Sloan Kettering Bergen

Montvale, NJ

Open and Accepting

New York

Memorial Sloan Kettering Cancer Center

New York, NY

Open and Accepting

Memorial Sloan Kettering Cancer Center

Commack, NY

Open and Accepting

Memorial Sloan Kettering Cancer Center Nassau

Uniondale, NY

Open and Accepting

Memorial Sloan Kettering Cancer Center

West Harrison, NY

Open and Accepting
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