[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652837":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":22,"centralContacts":26,"locations":31,"responsibleParty":57,"collaborators":12,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":14,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":12,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":85,"overallStatus":34,"whyStopped":12,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Texas A&M University","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Control\u002FUsual Lifestyle with optional Delayed Intervention","NO_INTERVENTION","Participants randomized to usual lifestyle will continue with their usual lifestyle\u002F diet. Participants will undergo all scheduled study procedures. Upon completion of the 12-week of usual lifestyle, participants randomized to the delayed onset control group will be offered one month of the dietary intervention. The delayed intervention is optional.",null,{"label":14,"type":15,"description":12,"interventionNames":16},"Beef+","EXPERIMENTAL",[17],"Other: Beef+",[19],{"type":6,"name":14,"description":20,"armGroupLabels":21,"otherNames":12},"Adolescents will be instructed to consume a minimum of 1 (3oz) serving per day of cooked unprocessed, lean (\\\u003C10% fat) beef (21 oz\u002Fweek) for 12 weeks. To facilitate adoption, the intervention will be offered at the household level, but it is not a requirement. The intervention is a multi-modal behavior change intervention with three overarching components: modifying beef intake, consuming beef in healthy meals, and the research team purchasing the beef needed for the intervention. To facilitate adoption of lean beef as part of a healthy diet, a study RDN will meet with the participant and at least one representative parent\u002Fguardian at bi-weekly check-ins to provide tailored dietary support and develop an implementation plan. A financial supplement of $100\u002Fmonth will be provided offset grocery costs.",[14],[23],{"name":24,"affiliation":5,"role":25},"Heidi K Vanden Brink, PhD, MSc, RDMS","PRINCIPAL_INVESTIGATOR",[27],{"name":24,"role":28,"phone":29,"phoneExt":12,"email":30},"CONTACT","979-321-7073","heidi.vandenbrink@ag.tamu.edu",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Texas A&M AgriLife","RECRUITING","College Station","Texas","77843","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-96.33441,30.62798,{"lat":44,"lon":43},[47,50,53,55],{"name":48,"role":28,"phone":49,"phoneExt":12,"email":30},"Heidi Vanden Brink","979--321-7073",{"name":51,"role":52,"phone":12,"phoneExt":12,"email":12},"Michele Garant, DO","SUB_INVESTIGATOR",{"name":54,"role":52,"phone":12,"phoneExt":12,"email":12},"Seung-Yeon \"Shawn\" Ha, PhD",{"name":56,"role":52,"phone":12,"phoneExt":12,"email":12},"Lilian Ademu, PhD",{"type":25,"investigatorFullName":48,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Principal Investigator","100652837","lean-beef-as-part-of-a-healthy-meal-plan-in-adolescents-with-polycystic-ovary-syndrome-pcospolyendocrine-metabolic-ovarian-syndrome-pmos-100652837",false,"NCT07780188","Lean Beef as Part of a Healthy Meal Plan in Adolescents With Polycystic Ovary Syndrome (PCOS)\u002FPolyendocrine Metabolic Ovarian Syndrome (PMOS)","Effect of Increasing Lean Beef Intake as Part of a Healthy Meal Plan on Glycemic Control in Adolescents With Polycystic Ovary Syndrome (PCOS)\u002FPolyendocrine Metabolic Ovarian Syndrome (PMOS)","Inclusion Criteria:\n\n* Female Adolescent\n* 11-17 years old\n* Suspected or confirmed diagnosis of PCOS\n* ≥1-year post-menarche\n* BMI ≥85th percentile for age\u002Fheight\n* Able to read and speak English\n\nExclusion Criteria:\n\n* Medications affecting glucoregulation, metabolic health, and\u002For appetite (e.g., metformin, GLP-1)\n* Unable or unwilling to eat beef\n* Pregnant or planning pregnancy during study\n* HbA1c ≥6.5%\n* Unwilling or unable to complete study procedures\n* Conditions affecting ability to complete study procedures or the intervention such as gastrointestinal diseases or syndromes, bleeding disorders, ongoing or unresolved eating disorder)\n* Conditions affecting reproductive function other than PCOS\n* Conditions that may interfere with continuous glucose monitor (CGM) application or use, including dermatological conditions such as eczema or allergies\u002Freactions to medical adhesives\n\nConditional Exclusion Criteria:\n\n\\- Current use of hormonal contraceptives if in the suspected PCOS group (allowable if current for at least the previous 3 months with physician-confirmed PCOS)","FEMALE","11 Years","17 Years",{"count":70,"type":71},36,"ESTIMATED","INTERVENTIONAL",[74],"NA","This pilot randomized controlled study will plan to enroll 36 adolescent females with Polycystic Ovary Syndrome (PCOS)\u002FPolyendocrine Metabolic Ovarian Syndrome (PMOS) to evaluate the effectiveness and feasibility of a tailored dietary intervention which will be termed \"Beef+\", that will emphasize the incorporation of unprocessed, lean beef (\\\u003C10% fat) as part of a healthy meal plan to improve glycemic control, diet quality, and health-related quality of life",[77,78,79,80,81,82,83,84],"PCOS (Polycystic Ovary Syndrome)","Obese Adolescents","Overweight (Without Type 2 Diabetes) With Weight-related Comorbidities","Overweight Adolescents","Irregular Menstrual Cycle","Irregular Menstrual Cycles","Hirsutism","Hyperandrogenism",[86,87,88,89],"Dietary Intervention","Polycystic Ovary Syndrome (PCOS)","Adolescents","Randomized Control Trial","2026-08-19",{"date":92,"type":93},"2026-08-21","ACTUAL",{"date":95,"type":71},"2026-09-01",{"date":97,"type":71},"2028-04-30",{"name":5,"class":6},1]