[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100488494":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":40,"centralContacts":44,"locations":52,"responsibleParty":148,"collaborators":150,"id":164,"slug":30,"hasResults":165,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":30,"eligibilityCriteria":169,"healthyVolunteers":165,"sex":170,"minAge":171,"maxAge":30,"enrollmentInfo":172,"targetDuration":30,"studyType":175,"phases":176,"briefSummary":178,"conditions":179,"keywords":182,"overallStatus":55,"whyStopped":30,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":194},{"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",[53,70,82,93,104,116,127,137],{"facility":54,"status":55,"city":56,"state":57,"zip":58,"country":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Emory University (Data Collection Only)","RECRUITING","Atlanta","Georgia","30322","United States",{"type":61,"coordinates":62},"Point",[63,64],-84.38798,33.749,{"lat":64,"lon":63},[67],{"name":68,"role":46,"phone":69,"phoneExt":30,"email":30},"Nisha Joseph, MD","404-778-0519",{"facility":71,"status":55,"city":72,"state":73,"zip":74,"country":59,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"Memorial Sloan Kettering Basking Ridge (All Protocol Activities)","Basking Ridge","New Jersey","07920",{"type":61,"coordinates":76},[77,78],-74.54932,40.70621,{"lat":78,"lon":77},[81],{"name":42,"role":46,"phone":47,"phoneExt":30,"email":30},{"facility":83,"status":55,"city":84,"state":73,"zip":85,"country":59,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Memorial Sloan Kettering Monmouth (All Protocol Activities)","Middletown","07748",{"type":61,"coordinates":87},[88,89],-74.11709,40.39428,{"lat":89,"lon":88},[92],{"name":42,"role":46,"phone":47,"phoneExt":30,"email":30},{"facility":94,"status":55,"city":95,"state":73,"zip":96,"country":59,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Memorial Sloan Kettering Bergen (All Protocol Activities)","Montvale","07645",{"type":61,"coordinates":98},[99,100],-74.02292,41.04676,{"lat":100,"lon":99},[103],{"name":42,"role":46,"phone":47,"phoneExt":30,"email":30},{"facility":105,"status":55,"city":106,"state":107,"zip":108,"country":59,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)","Commack","New York","11725",{"type":61,"coordinates":110},[111,112],-73.29289,40.84288,{"lat":112,"lon":111},[115],{"name":42,"role":46,"phone":47,"phoneExt":30,"email":30},{"facility":117,"status":55,"city":118,"state":107,"zip":119,"country":59,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"Memorial Sloan Kettering Westchester (All Protocol Activities)","Harrison","10604",{"type":61,"coordinates":121},[122,123],-73.71263,40.96899,{"lat":123,"lon":122},[126],{"name":42,"role":46,"phone":47,"phoneExt":30,"email":30},{"facility":128,"status":55,"city":107,"state":107,"zip":129,"country":59,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"Memorial Sloan Kettering Cancer Center (All Protocol Activities)","10065",{"type":61,"coordinates":131},[132,133],-74.00597,40.71427,{"lat":133,"lon":132},[136],{"name":42,"role":46,"phone":47,"phoneExt":30,"email":30},{"facility":138,"status":55,"city":139,"state":107,"zip":140,"country":59,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"Memorial Sloan Kettering Nassau (All Protocol Activities)","Uniondale","11553",{"type":61,"coordinates":142},[143,144],-73.59291,40.70038,{"lat":144,"lon":143},[147],{"name":42,"role":46,"phone":47,"phoneExt":30,"email":30},{"type":149,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[151,154,156,158,160,162],{"name":152,"class":153},"Paula and Rodger Riney Foundation","UNKNOWN",{"name":155,"class":153},"Plantable",{"name":157,"class":153},"M and M labs",{"name":159,"class":153},"VeggieDoctor",{"name":161,"class":153},"Sabinsa pharmaceuticals",{"name":163,"class":153},"Daily Harvest","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":173,"type":174},180,"ESTIMATED","INTERVENTIONAL",[177],"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.",[180,181],"Monoclonal Gammopathy of Undetermined Significance","Smoldering Multiple Myeloma",[183,15,184],"Plant-Based Diet","22-175","2026-04-15",{"date":187,"type":188},"2026-04-16","ACTUAL",{"date":190,"type":188},"2022-11-29",{"date":192,"type":174},"2026-11",{"name":5,"class":6},8]