[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100520386":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":44,"centralContacts":48,"locations":56,"responsibleParty":141,"collaborators":143,"id":146,"slug":147,"hasResults":148,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":34,"eligibilityCriteria":152,"healthyVolunteers":148,"sex":153,"minAge":154,"maxAge":34,"enrollmentInfo":155,"targetDuration":34,"studyType":158,"phases":159,"briefSummary":161,"conditions":162,"keywords":166,"overallStatus":59,"whyStopped":34,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":179},{"fullName":5,"class":6},"Memorial Sloan Kettering Cancer Center","OTHER",[8,14,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Omega-3","EXPERIMENTAL","For 2 weeks, patients will receive omega 3 fatty acid supplements 1640 mg (2 capsules) twice daily Qwell™ Omega 3 by The Veggie Doctor™. Each 820 mg omega 3 supplement capsule contains 700 mg Docosohexaenoic acid, 100 mg Docosapentaenoic acid, and 20 mg Eicosapentaenoic acid. No dietary changes will be made but data on dietary intake will be collected.",[13],"Dietary Supplement: Omega-3",{"label":15,"type":10,"description":16,"interventionNames":17},"Curcumin","For 2 weeks, patients in the curcumin arm will receive Curcumin C3 complex 1000 mg with 5 mg BioPerine twice daily from Sabinsa pharmaceuticals. No dietary changes will be made but data on dietary intake will be collected.",[18],"Dietary Supplement: Curcumin",{"label":20,"type":10,"description":21,"interventionNames":22},"Probiotic","For 2 weeks, patients in the probiotic arm will receive Ultra-50 probiotics with 50 billion CFU per capsule (one capsule) twice daily from Vita Miracle pharmaceuticals. No dietary changes will be made but data on dietary intake will be collected.",[23],"Dietary Supplement: Probiotic",{"label":25,"type":10,"description":26,"interventionNames":27},"Whole food, plant-based diet (WFPBD)","For 2 weeks, on the WFPBD arm, patients will receive 14 items weekly, prepared and shipped by U.S. based company, Daily Harvest once a week. The meals will have range from 2 breakfast, 11 lunch\u002Fdinners, 1 snack (provided Week 1), and whole grains items (provided Week 2). The meals will contain legumes, fruits, vegetables, whole grains, and plant-based fats that have undergone minimal processing. Detailed recommendations for additional meals outside those given by Daily Harvet meeting the standard of a WFPBD will also be given to supplement their individual daily calorie needs through the guidance of the research dietitian. Patients will receive a varied menu created by Daily Harvest and the study team on a weekly basis.",[28],"Other: Whole food, plant-based diet (WFPBD)",[30,35,38,41],{"type":31,"name":9,"description":32,"armGroupLabels":33,"otherNames":34},"DIETARY_SUPPLEMENT","For 2 weeks, patients will receive omega 3 fatty acid supplements 1640 mg (2 capsules) twice daily",[9],null,{"type":31,"name":15,"description":36,"armGroupLabels":37,"otherNames":34},"For 2 weeks, patients in the curcumin arm will receive Curcumin C3 complex 1000 mg with 5 mg BioPerine twice daily",[15],{"type":31,"name":20,"description":39,"armGroupLabels":40,"otherNames":34},"For 2 weeks, patients in the probiotic arm will receive Ultra-50 probiotics with 50 billion CFU per capsule (one capsule) twice daily",[20],{"type":6,"name":25,"description":42,"armGroupLabels":43,"otherNames":34},"Daily Harvest once a week. The meals will have range from 2 breakfast, 11 lunch\u002Fdinners, 1 snack (provided Week 1), and whole grains items (provided Week 2).",[25],[45],{"name":46,"affiliation":5,"role":47},"Urvi A Shah, MD, MS","PRINCIPAL_INVESTIGATOR",[49,53],{"name":46,"role":50,"phone":51,"phoneExt":34,"email":52},"CONTACT","646-608-3713","ShahNutrivention@mskcc.org",{"name":54,"role":50,"phone":55,"phoneExt":34,"email":34},"Alexander Lesokhin, MD","646-608-3717",[57,73,84,95,109,120,130],{"facility":58,"status":59,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"Memorial Sloan Kettering Basking Ridge (All Protocol Activities)","RECRUITING","Basking Ridge","New Jersey","07920","United States","US",{"type":66,"coordinates":67},"Point",[68,69],-74.54932,40.70621,{"lat":69,"lon":68},[72],{"name":46,"role":50,"phone":51,"phoneExt":34,"email":34},{"facility":74,"status":59,"city":75,"state":61,"zip":76,"country":63,"countryCode":64,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Memorial Sloan Kettering Monmouth (All Protocol Activities)","Middletown","07748",{"type":66,"coordinates":78},[79,80],-74.11709,40.39428,{"lat":80,"lon":79},[83],{"name":46,"role":50,"phone":51,"phoneExt":34,"email":34},{"facility":85,"status":59,"city":86,"state":61,"zip":87,"country":63,"countryCode":64,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"Memorial Sloan Kettering Bergen (All Protocol Activities)","Montvale","07645",{"type":66,"coordinates":89},[90,91],-74.02292,41.04676,{"lat":91,"lon":90},[94],{"name":46,"role":50,"phone":51,"phoneExt":34,"email":34},{"facility":96,"status":59,"city":97,"state":98,"zip":99,"country":63,"countryCode":64,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)","Commack","New York","11725",{"type":66,"coordinates":101},[102,103],-73.29289,40.84288,{"lat":103,"lon":102},[106],{"name":107,"role":50,"phone":108,"phoneExt":34,"email":34},"Thomas Kaley, MD","212-639-5122",{"facility":110,"status":59,"city":111,"state":98,"zip":112,"country":63,"countryCode":64,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"Memorial Sloan Kettering Westchester (All Protocol Activities)","Harrison","10604",{"type":66,"coordinates":114},[115,116],-73.71263,40.96899,{"lat":116,"lon":115},[119],{"name":46,"role":50,"phone":51,"phoneExt":34,"email":34},{"facility":121,"status":59,"city":98,"state":98,"zip":122,"country":63,"countryCode":64,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"Memorial Sloan Kettering Cancer Center (All Protocol Activities)","10065",{"type":66,"coordinates":124},[125,126],-74.00597,40.71427,{"lat":126,"lon":125},[129],{"name":46,"role":50,"phone":51,"phoneExt":34,"email":34},{"facility":131,"status":59,"city":132,"state":98,"zip":133,"country":63,"countryCode":64,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"Memorial Sloan Kettering Nassau (All Protocol Activities)","Uniondale","11553",{"type":66,"coordinates":135},[136,137],-73.59291,40.70038,{"lat":137,"lon":136},[140],{"name":46,"role":50,"phone":51,"phoneExt":34,"email":34},{"type":142,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR",[144],{"name":145,"class":6},"HealthTree Foundation","100520386","a-study-of-a-plant-based-diet-and-dietary-supplements-in-people-with-smoldering-multiple-myeloma-smm-or-monoclonal-gammopathy-of-undetermined-significance-mgus-100520386",false,"NCT06055894","A Study of a Plant-Based Diet and Dietary Supplements in People With Smoldering Multiple Myeloma (SMM) or Monoclonal Gammopathy of Undetermined Significance (MGUS)","Microbial Changes in Response to a Plant Based Diet and\u002For Supplements in SMM\u002FMGUS Patients: A National Multi-Arm Randomized Prospective Telehealth Study Via HealthTree","Inclusion Criteria:\n\n* 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.\n* Age ≥18 years\n* Willingness to comply with all study-related procedures\n* 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)\n* Interested in learning to cook plant-based recipes\n* Access to smart mobile phone or device with camera and ability to download Keenoa app\n* Be residing within the United States for the study duration.\n* English speaking or a family member or caregiver who speaks English and is able to assist with the surveys and phone based Keenoa app.\n\nExclusion Criteria:\n\n* 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.\n* 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.\n* Legume allergy\n* Severe allergies such as anaphylactic shock to peanuts and\u002For tree nuts, such as cashews\n* Concurrent participation in weight loss\u002Fdietary trials or defined programs (that require specified diets\u002Fsupplements on the program). Patients on weight loss drugs are eligible.\n* Mental impairment leading to inability to cooperate\n* Enrollment onto any other therapeutic investigational study\n* Concurrent pregnancy\n* Patients on full dose anticoagulation\n* If in the opinion of the investigator there maybe any concerns regarding the ability of the patient to complete the study safely\n* Current self-reported heavy alcohol use and is defined as \\>5 drinks per day or \\>15 drinks per week\n* Current self-reported illicit drug use (except inhaled marijuana, vaping or cigarette smoking or medical marijuana.\n* Has a condition requiring antibiotics within 14 days of study intervention administration.\n* Plan for travel during the study that would preclude adherence to prescribed diets\n* 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)","ALL","18 Years",{"count":156,"type":157},200,"ESTIMATED","INTERVENTIONAL",[160],"NA","The researchers are going this 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) or monoclonal gammopathy of undetermined significance (MGUS). The researchers will compare how the different dietary changes affect butyrate levels in participants' stool.",[163,164,165],"Multiple Myeloma, Smoldering","Multiple Myeloma","Monoclonal Gammopathy of Undetermined Significance",[167,168,169],"Plant-Based Diet","Dietary Supplements","23-116","2025-11-12",{"date":172,"type":173},"2025-11-13","ACTUAL",{"date":175,"type":173},"2023-09-20",{"date":177,"type":157},"2026-09",{"name":5,"class":6},7]