A Study of a Plant-Based Diet and Dietary Supplements in People With Smoldering Multiple Myeloma (SMM) or Monoclonal Gammopathy of Undetermined Significance (MGUS)

Korábbi kezelés

• Concurrent participation in weight loss/dietary trials or defined programs (that require specified diets/supplements on the program). Patients on weight loss drugs are eligible.
• Concurrent pregnancy
• Current self-reported illicit drug use (except inhaled marijuana, vaping or cigarette smoking or medical marijuana.

Más betegség

• Legume allergy
• Severe allergies such as anaphylactic shock to peanuts and/or tree nuts, such as cashews
• Mental impairment leading to inability to cooperate
• Has a condition requiring antibiotics within 14 days of study intervention administration.
• 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)

Laborértékek

• 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.

Egyéb

• 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.
• Enrollment onto any other therapeutic investigational study
• Patients on full dose anticoagulation
• 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 and is defined as >5 drinks per day or >15 drinks per week
• Plan for travel during the study that would preclude adherence to prescribed diets

• Confirmed prior diagnosis MGUS or of smoldering myeloma (any time 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.