An official website of the United States government
Government Funding Lapse Because of a lapse in government funding, the information on this website may not be up to date, transactions submitted via the website may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted.
The NIH Clinical Center (the research hospital of NIH) is open. For more details about its operating status, please visit cc.nih.gov.
Updates regarding government operating status and resumption of normal operations can be found at opm.gov.
A Study of a Plant-Based Diet and Dietary Supplements in People with Smoldering Multiple Myeloma or Monoclonal Gammopathy of Undetermined Significance
Trial Status: active
This clinical trial evaluates how a plant-based diet and dietary supplements (omega 3, curcumin, probiotics) change the level of fatty acids in the stool of patients with smoldering multiple myeloma or monoclonal gammopathy of undetermined significance (MGUS). A plant-based diet includes foods that are mainly from plants (for example, fruits, vegetables, nuts, beans, and whole grains). Omega-3 is a group of fatty acids that are naturally found in foods and which help build and maintain a healthy body. Curcumin is a natural substance found in the spice turmeric that may help reduce inflammation. Probiotics are foods or supplements that contain live microorganisms that are naturally found in the body. One of the gut bacteria’s important substances is butyrate, a short chain fatty acid that is produced by some types of gut bacteria when they break down or digest fiber. Butyrate is being investigated for its effect on both cancer and inflammation. Researchers have seen that a plant-based diet or dietary supplements (omega 3, curcumin, and probiotics) are associated with an increase in butyrate levels, and are studying to see if it may prevent multiple myeloma from developing in people with smoldering multiple myeloma or MGUS.
Inclusion Criteria
Confirmed prior diagnosis of MGUS or smoldering myeloma (anytime prior). However, confirmation of diagnosis must be documented in their last local oncologist clinic note within 12 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
HOUSEHOLD HEALTHY CONTROL: Age ≥ 18 years
HOUSEHOLD HEALTHY CONTROL: Confirmed no current malignancy (through patient confirmation at time of
consent)
HOUSEHOLD HEALTHY CONTROL: Currently living in same household as consented patient (through patient
confirmation at time of consent)
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 principal investigator (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-lacto-vegetarian 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
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 > 5 drinks per day or > 15 drinks per week)
Current self-reported illicit drug use (except inhaled marijuana, vaping or cigarette smoking or medical marijuana)
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). Irritable bowel syndrome is not excluded
Additional locations may be listed on ClinicalTrials.gov for NCT06055894.
Locations matching your search criteria
United States
New Jersey
Basking Ridge
Memorial Sloan Kettering Basking Ridge
Status: Active
Contact: Urvi A Shah
Phone: 646-608-3713
Middletown
Memorial Sloan Kettering Monmouth
Status: Active
Contact: Urvi A Shah
Phone: 646-608-3713
Montvale
Memorial Sloan Kettering Bergen
Status: Active
Contact: Urvi A Shah
Phone: 646-608-3713
New York
Commack
Memorial Sloan Kettering Commack
Status: Active
Contact: Urvi A Shah
Phone: 646-608-3713
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: Urvi A Shah
Phone: 646-608-3713
Uniondale
Memorial Sloan Kettering Nassau
Status: Active
Contact: Urvi A Shah
Phone: 646-608-3713
West Harrison
Memorial Sloan Kettering Westchester
Status: Active
Contact: Urvi A Shah
Phone: 646-608-3713
PRIMARY OBJECTIVE:
I. To evaluate the change in relative abundance of stool butyrate producers on plant based diet, curcumin supplementation, omega 3 supplementation, and probiotic supplementation at 2 weeks compared to baseline, which is defined as the average of -1 and 0 week samples.
SECONDARY OBJECTIVES:
I. To evaluate the change in relative abundance of stool butyrate producers on plant based diet, curcumin supplementation, omega 3 supplementation, and probiotic supplementation at 1 week when compared to baseline, which is defined as the average of -1 and 0 week samples.
II. To evaluate the change in relative abundance of stool butyrate concentrations on a plant based diet, curcumin supplementation, omega 3 supplementation, and probiotic supplementation at 1 or 2 weeks when compared to baseline, which is defined as the average of -1 and 0 week samples.
III. To evaluate the change in stool alpha diversity on plant based diet, curcumin supplementation, omega 3 supplementation, and probiotic supplementation at 1 or 2 weeks when compared to baseline, which is
defined as the average of -1 and 0 week samples.
IV. To evaluate the dietary or supplement compliance at 2 weeks.
V. To determine the effects of a dietary and supplement interventions, on quality-of-life measures at 2 weeks compared to baseline.
VI. To evaluate differences in baseline dietary pattern for the groups.
EXPLORATORY OBJECTIVES:
I. To assess alterations in the fecal short chain fatty acids for the groups at 1 and 2 weeks compared to baseline which is defined as the average of -1 and 0 week samples.
II. To assess alterations in the fecal microbiome secondary to a plant based diet, curcumin supplementation, omega 3 supplementation, and probiotic supplementation at 1 and 2 weeks compared to baseline, which is defined as the average of -1 and 0 week samples.
III. To compare differences in results for primary, secondary and exploratory objectives based on racial background.
IV. To compare microbiome changes in patients based on MGUS and smoldering myeloma risk stratification and amongst those that progressed to multiple myeloma and those that were stable.
V. Healthy Controls: To compare microbiome differences in household healthy controls to patients with MGUS/smoldering multiple myeloma (SMM) at baseline (which is defined as the average of -1 and 0 week samples), as well as to those with -2 week samples (both patients deemed eligible and not eligible for the intervention after the initial confirmation of diagnosis).
OUTLINE: Patients are randomized to 1 of 4 arms.
ARM I: Patients receive 14 pre-made frozen whole food plant-based meals once a week for 2 weeks on study. Patients also receive detailed recommendations for additional meals meeting the standards of a whole food plant-based diet (WFPBD) and receive dietary education and counseling from a research dietitian once a week for 5 weeks on study. Patients use the Keenoa application (app) to take photos of their food and to log the food and the portion eaten. Patients also undergo stool sample collection on study.
ARM II: Patients receive omega 3 fatty acid supplements orally (PO) twice daily (BID) for 2 weeks on study. Patients use the Keenoa app to take photos of their food and to log the food and the portion eaten. Patients also undergo stool sample collection on study.
ARM III: Patients receive curcumin/demethoxycurcumin/bisdemethoxycurcumin-containing supplement (curcumin C3 complex) with piperine extract (standardized) (BioPerine) PO BID for 2 weeks on study. Patients use the Keenoa app to take photos of their food and to log the food and the portion eaten. Patients also undergo stool sample collection on study.
ARM IV: Patients receive Ultra-50 probiotics PO BID for 2 weeks on study. Patients use the Keenoa app to take photos of their food and to log the food and the portion eaten. Patients also undergo stool sample collection on study.
Trial PhaseNo phase specified
Trial Typeprevention
Lead OrganizationMemorial Sloan Kettering Cancer Center
