[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555510":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":32,"locations":41,"responsibleParty":60,"collaborators":62,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":77,"acronym":24,"eligibilityCriteria":78,"healthyVolunteers":75,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":24,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":95,"overallStatus":44,"whyStopped":24,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Albert Einstein College of Medicine","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Lactose-Containing Milk","ACTIVE_COMPARATOR","Participants will be randomized to lactose-containing milk in strata of age (\\\u003C60, ≥60) and sex (female, male). Within each age and sex stratum, 10 participants will be randomized into two intervention groups in a 1:1 ratio",[13],"Dietary Supplement: Lactose-Containing Milk",{"label":15,"type":10,"description":16,"interventionNames":17},"Lactose-Free Milk","Participants will be randomized to lactose-free milk in strata of age (\\\u003C60, ≥60) and sex (female, male). Within each age and sex stratum, 10 participants will be randomized into two intervention groups in a 1:1 ratio",[18],"Dietary Supplement: Lactose-Free Milk",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DIETARY_SUPPLEMENT","Participants will be asked to drink regular milk (1% or 2%) for 12 weeks as follows:\n\n* Weeks 1-4: ½ cup milk per day\n* Weeks 5-8: 1 cup milk per day\n* Weeks 9-12: 2 cups milk per day\n\nParticipants will continue drinking 2 cups milk\u002Fday for 2 weeks after the 12-week follow-up visit.",[9],null,{"type":21,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"Participants will be asked to drink 1% or 2% lactose-free milk for 12 weeks as follows:\n\n* Weeks 1-4: ½ cup milk per day\n* Weeks 5-8: 1 cup milk per day\n* Weeks 9-12: 2 cups milk per day\n\nParticipants will continue drinking 2 cups milk\u002Fday for 2 weeks after the 12-week follow-up visit.",[15],[29],{"name":30,"affiliation":5,"role":31},"Brandilyn Peters-Samuelson, PhD","PRINCIPAL_INVESTIGATOR",[33,37],{"name":30,"role":34,"phone":35,"phoneExt":24,"email":36},"CONTACT","718-430-3281","brandilyn.peterssamuelson@einsteinmed.edu",{"name":38,"role":34,"phone":39,"phoneExt":24,"email":40},"Qibin Qi, PhD","718-430-4203","qibin.qi@einsteinmed.edu",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"HCHS\u002FSOL Bronx Field Center","RECRUITING","The Bronx","New York","10458","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-73.86641,40.84985,{"lat":54,"lon":53},[57],{"name":24,"role":34,"phone":58,"phoneExt":24,"email":59},"718-584-1563","milkstudy@einsteinmed.edu",{"type":61,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[63,65,68,70],{"name":64,"class":6},"National Dairy Council",{"name":66,"class":67},"University of Minnesota (UM) Advanced Research and Diagnostic Laboratory (ARDL)","UNKNOWN",{"name":69,"class":67},"Azenta Life Sciences",{"name":71,"class":72},"Metabolic Solutions Inc.","INDUSTRY","100555510","milk-for-diabetes-prevention-100555510",false,"NCT06513026","Milk for Diabetes Prevention","Inclusion Criteria:\n\n* LNP genotype (LCT gene rs4988235, GG genotype)\n* History of pre-diabetes, defined as fasting blood glucose 100-125 mg\u002FdL and\u002For hemoglobin A1c (HbA1c) 5.7-6.4% and have not been diagnosed with diabetes nor take diabetes medication (pre-diabetes determined at most recent study visit \\[for HCHS\u002FSOL participant\\] or most recent medical chart or self-report \\[for other participant\\])\n* Drink ≤1 cup milk\u002Fday\n* Basic computer or smartphone skills\n* Can speak and read English fluently\n\nExclusion Criteria:\n\n* Diabetes diagnosis\n* Taking anti-diabetes medication\n* Cancer, cardiovascular disease (CVD), or life-threatening illness\n* Known milk allergy\n* Has severe GI symptoms after drinking milk\n* History of GI surgery\n* Had a double mastectomy\n* Smoking\n* More than 1 alcoholic beverage\u002Fday\n* Pregnant or breastfeeding\n* Colonoscopy in last 2 weeks\n* Antibiotics in last 3 months\n* Taking probiotics or fiber supplements (if taking, must be able to stop taking during study)\n* Taking laxatives, stool softeners, anti-diarrheal (if taking, must be able to stop taking during study)\n* Taking lactase pills (if taking, must be able to stop taking)\n* Participating in extreme dieting program\n* Planning extended travel that would prevent participation in study\n* Taking medication that must be taken separate from calcium or dairy products","ALL","18 Years","70 Years",{"count":83,"type":84},40,"ESTIMATED","INTERVENTIONAL",[87],"NA","Individuals with lactase non-persistence (LNP; determined by a functional variant in the LCT gene \\[rs4988235, GG genotype\\]) are susceptible to lactose intolerance in adulthood due to deficiency of lactase, the enzyme which digests milk lactose sugars. However, many LNP individuals still drink ≥1 cup of milk daily. Recent analysis in the Hispanic Community Health Study\u002FStudy of Latinos (HCHS\u002FSOL) found that consumption of 1 serving (cup) of milk\u002Fday was associated with \\~30% lower risk of type 2 diabetes among LNP individuals, but not among individuals with lactase persistence (LP). This beneficial effect might be partially explained by favorable alterations in gut microbiota and related metabolites associated with higher milk consumption among LNP individuals. Based on these observational study findings, the investigator team proposes to conduct a randomized, controlled trial of lactose-containing vs. lactose-free milk in LNP individuals with pre-diabetes, to comprehensively investigate the effects of milk intake on the gut microbiome and glycemic outcomes.",[90,91,92,93,94],"Lactose Intolerance","Lactose Intolerant","Lactase Persistence","Pre-Diabetes","Diabetes Mellitus, Type 2",[96,97,98],"Lactose","Lactose-free","Lactase Non Persistence","2026-05-21",{"date":101,"type":102},"2026-05-26","ACTUAL",{"date":104,"type":102},"2026-05-15",{"date":106,"type":84},"2028-04",{"name":5,"class":6},1]