[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100488494":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":40,"centralContacts":44,"locations":52,"responsibleParty":149,"collaborators":151,"id":165,"slug":166,"hasResults":167,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":30,"eligibilityCriteria":171,"healthyVolunteers":167,"sex":172,"minAge":173,"maxAge":30,"enrollmentInfo":174,"targetDuration":30,"studyType":177,"phases":178,"briefSummary":180,"conditions":181,"keywords":184,"overallStatus":55,"whyStopped":30,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":196},{"fullName":5,"class":6},"Memorial Sloan Kettering Cancer Center","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Daily Harvest weekly","EXPERIMENTAL","For 12 weeks, on the Daily Harvest weekly arm, patients will receive two premade meals per day, for lunch and dinner for 6 days weekly, prepared and shipped by U.S.-based company Daily Harvest weekly.",[13],"Other: Whole Foods Plant-based Diet",{"label":15,"type":10,"description":16,"interventionNames":17},"Supplements","For 12 weeks on the supplement arm, patients will be given algae omega 3 supplements (QWell pharmaceuticals) and curcumin supplements (Sabinsa pharmaceuticals) twice daily.",[18],"Dietary Supplement: Algae Omega 3 + Curcumin",{"label":20,"type":21,"description":22,"interventionNames":23},"Placebo","PLACEBO_COMPARATOR","For 12 weeks on the placebo arm, patients will be given placebo supplements twice daily (QWell and Sabinsa pharmaceuticals).",[24],"Other: Placebo supplements",[26,31,36],{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"Whole Foods Plant-based Diet","The meals will have a low glycemic index and contain legumes, vegetables, whole grains, and plant-based fats that have undergone minimal processing. Detailed recommendations for snacks and breakfasts meeting the standard of a WFPBD will also be given to supplement their daily calorie needs with access to education materials. Patients will also receive dietary education and counselling from a research dietitian every 4 weeks for the 12-week intervention period. They will have access to the team for questions and support as needed",[9],null,{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":30},"DIETARY_SUPPLEMENT","Algae Omega 3 + Curcumin","For 52 weeks on the supplement arm, patients will be given algae omega 3 supplements and curcumin supplements (Sabinsa pharmaceuticals) twice daily",[15],{"type":6,"name":37,"description":38,"armGroupLabels":39,"otherNames":30},"Placebo supplements","For 25 weeks on the placebo arm, patients will be given placebo supplements twice daily (Veggie Doctor\u002FM and M pharmaceuticals and Sabinsa pharmaceuticals).",[20],[41],{"name":42,"affiliation":5,"role":43},"Urvi A Shah, MD, MS","PRINCIPAL_INVESTIGATOR",[45,49],{"name":42,"role":46,"phone":47,"phoneExt":30,"email":48},"CONTACT","646-608-3713","ShahNutrivention@mskcc.org",{"name":50,"role":46,"phone":51,"phoneExt":30,"email":30},"Alexander Lesokhin, MD","646-608-3717",[53,71,83,94,105,117,128,138],{"facility":54,"status":55,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Emory University (Data Collection Only)","RECRUITING","Atlanta","Georgia","30322","United States","US",{"type":62,"coordinates":63},"Point",[64,65],-84.38798,33.749,{"lat":65,"lon":64},[68],{"name":69,"role":46,"phone":70,"phoneExt":30,"email":30},"Nisha Joseph, MD","404-778-0519",{"facility":72,"status":55,"city":73,"state":74,"zip":75,"country":59,"countryCode":60,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Memorial Sloan Kettering Basking Ridge (All Protocol Activities)","Basking Ridge","New Jersey","07920",{"type":62,"coordinates":77},[78,79],-74.54932,40.70621,{"lat":79,"lon":78},[82],{"name":42,"role":46,"phone":47,"phoneExt":30,"email":30},{"facility":84,"status":55,"city":85,"state":74,"zip":86,"country":59,"countryCode":60,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Memorial Sloan Kettering Monmouth (All Protocol Activities)","Middletown","07748",{"type":62,"coordinates":88},[89,90],-74.11709,40.39428,{"lat":90,"lon":89},[93],{"name":42,"role":46,"phone":47,"phoneExt":30,"email":30},{"facility":95,"status":55,"city":96,"state":74,"zip":97,"country":59,"countryCode":60,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"Memorial Sloan Kettering Bergen (All Protocol Activities)","Montvale","07645",{"type":62,"coordinates":99},[100,101],-74.02292,41.04676,{"lat":101,"lon":100},[104],{"name":42,"role":46,"phone":47,"phoneExt":30,"email":30},{"facility":106,"status":55,"city":107,"state":108,"zip":109,"country":59,"countryCode":60,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)","Commack","New York","11725",{"type":62,"coordinates":111},[112,113],-73.29289,40.84288,{"lat":113,"lon":112},[116],{"name":42,"role":46,"phone":47,"phoneExt":30,"email":30},{"facility":118,"status":55,"city":119,"state":108,"zip":120,"country":59,"countryCode":60,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"Memorial Sloan Kettering Westchester (All Protocol Activities)","Harrison","10604",{"type":62,"coordinates":122},[123,124],-73.71263,40.96899,{"lat":124,"lon":123},[127],{"name":42,"role":46,"phone":47,"phoneExt":30,"email":30},{"facility":129,"status":55,"city":108,"state":108,"zip":130,"country":59,"countryCode":60,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"Memorial Sloan Kettering Cancer Center (All Protocol Activities)","10065",{"type":62,"coordinates":132},[133,134],-74.00597,40.71427,{"lat":134,"lon":133},[137],{"name":42,"role":46,"phone":47,"phoneExt":30,"email":30},{"facility":139,"status":55,"city":140,"state":108,"zip":141,"country":59,"countryCode":60,"cosmosGeoPoint":142,"geoPoint":146,"contacts":147},"Memorial Sloan Kettering Nassau (All Protocol Activities)","Uniondale","11553",{"type":62,"coordinates":143},[144,145],-73.59291,40.70038,{"lat":145,"lon":144},[148],{"name":42,"role":46,"phone":47,"phoneExt":30,"email":30},{"type":150,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[152,155,157,159,161,163],{"name":153,"class":154},"Paula and Rodger Riney Foundation","UNKNOWN",{"name":156,"class":154},"Plantable",{"name":158,"class":154},"M and M labs",{"name":160,"class":154},"VeggieDoctor",{"name":162,"class":154},"Sabinsa pharmaceuticals",{"name":164,"class":154},"Daily Harvest","100488494","a-study-comparing-a-plant-based-diet-with-supplements-and-placebo-in-people-with-monoclonal-gammopathy-of-undetermined-significance-mgus-or-smoldering-multiple-myeloma-smm-100488494",false,"NCT05640843","A Study Comparing a Plant-Based Diet With Supplements and Placebo in People With Monoclonal Gammopathy of Undetermined Significance (MGUS) or Smoldering Multiple Myeloma (SMM)","A Randomized Placebo Controlled Study of a Plant-Based Dietary Versus Supplement Versus Placebo Intervention in Patients With Monoclonal Gammopathy of Undetermined Significance (MGUS) and Smoldering Multiple Myeloma (SMM) - The Nutrition Prevention (NUTRIVENTION-3) Study","Inclusion Criteria:\n\n* Confirmed diagnosis of MGUS or SMM\n* If non light chain MGUS\u002FSMM then M spike must be either ≥ 0.2 g\u002FdL or BM PC ≥10% (both not required)\n* If light chain MGUS\u002FSMM then involved must be ≥10 mg\u002FdL or BM PC ≥10% (both not required)\n* If IgA MGUS\u002FSMM then an IgA level \\>350 mg\u002FdL and an abnormal immunofixation is required (M spike criteria not required).\n* If IgD MGUS\u002FSMM then an IgD level \\>50 mg\u002FdL and an abnormal immunofixation is required (M spike criteria not required).\n* Age ≥18 years\n* Willingness to comply with all study-related procedures\n* ECOG performance status of 0-3\n* Interested in learning to cook plant based recipes\n\nExclusion Criteria:\n\n* Patients that already follow a whole foods plant based diet (ovo-lacto-vegetarian or processed junk food vegan diets are not excluded)\n* Legume allergy\n* Severe allergies such as anaphylactic shock to nuts (specifically cashews). Peanuts are not included in the meals.\n* Concurrent participation in weight loss\u002Fdietary\u002Fexercise programs\n* Mental impairment leading to inability to cooperate\n* Enrollment onto any other therapeutic investigational study concurrently and up to 180 days prior to study start date\n* Concurrent pregnancy\n* Positive HBV, HCV or HIV PCR test will need to be treated first and once undetectable viral load patients may enroll\n* ≥ Grade 2 electrolyte abnormalities as defined by CTCAEv5.0 (need to be resolved before enrolling on study)\n* If in the opinion of the investigator there maybe any concerns regarding the ability of the patient to complete the study safely or any contraindications\n* Heavy drinker (defined as \\>2 drinks per day or \\>14 drinks per week)\n* Current self-reported illicit drug use (eg heroin, cocaine not marijuana)\n* Plan for prolonged travel during the study that would preclude adherence to prescribed diets\n* History of major gastrointestinal surgery (not including appendectomy or cholecystectomy) within 3 months of enrollment\n* If already taking curcumin or omega 3 supplements patients must be willing to stop it on the date of trial consent for study duration.","ALL","18 Years",{"count":175,"type":176},180,"ESTIMATED","INTERVENTIONAL",[179],"NA","The researchers are doing this study to look at how butyrate levels change in participants' stool after they are on a- plant-based diet for at least 12 weeks. All participants will have monoclonal gammopathy of undetermined significance (MGUS) or smoldering multiple myeloma (SMM). We will compare how the plant-based diet, omega-3 fatty acid and curcumin supplements, and placebo (an inactive substance that looks like the study supplements) affect butyrate levels in participants' stool.",[182,183],"Monoclonal Gammopathy of Undetermined Significance","Smoldering Multiple Myeloma",[185,15,186],"Plant-Based Diet","22-175","2026-04-15",{"date":189,"type":190},"2026-04-16","ACTUAL",{"date":192,"type":190},"2022-11-29",{"date":194,"type":176},"2026-11",{"name":5,"class":6},8]