[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605146":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":11,"centralContacts":11,"locations":33,"responsibleParty":67,"collaborators":70,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":11,"eligibilityCriteria":80,"healthyVolunteers":81,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":11,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":36,"whyStopped":11,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"University of Arkansas, Fayetteville","OTHER",[8,14,18,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Calorie restricted control","ACTIVE_COMPARATOR",null,[13],"Other: Calorie restriction",{"label":15,"type":10,"description":11,"interventionNames":16},"Control and Protein",[17],"Other: Higher protein dietary pattern",{"label":19,"type":10,"description":11,"interventionNames":20},"Calorie restricted PCOS",[13],{"label":22,"type":10,"description":11,"interventionNames":23},"PCOS Protein",[17],[25,29],{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Higher protein dietary pattern","Follow energy-restricted (10% calorie reduction), higher protein dietary pattern (1.6 g protein\u002Fkg body weight)",[15,22],{"type":6,"name":30,"description":31,"armGroupLabels":32,"otherNames":11},"Calorie restriction","Follow energy-restricted (10% calorie reduction) dietary pattern for 16 weeks. No restrictions on macronutrient content.",[19,9],[34,60],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Center for Human Nutrition","RECRUITING","Fayetteville","Arkansas","72704","United States","US",{"type":43,"coordinates":44},"Point",[45,46],-94.15743,36.06258,{"lat":46,"lon":45},[49,54,57],{"name":50,"role":51,"phone":52,"phoneExt":11,"email":53},"Jamie Baum, PhD","CONTACT","479-575-4474","baum@uark.edu",{"name":55,"role":51,"phone":11,"phoneExt":11,"email":56},"Sydney Boudrey, MS, RDN","seboudre@uark.edu",{"name":58,"role":59,"phone":11,"phoneExt":11,"email":11},"Jamie I Baum, PhD","PRINCIPAL_INVESTIGATOR",{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":61,"geoPoint":63,"contacts":64},{"type":43,"coordinates":62},[45,46],{"lat":46,"lon":45},[65,66],{"name":50,"role":51,"phone":52,"phoneExt":11,"email":53},{"name":55,"role":51,"phone":11,"phoneExt":11,"email":56},{"type":59,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Jamie Baum","Associate Professor",[71],{"name":72,"class":73},"Arkansas Biosciences Institute","UNKNOWN","100605146","protein-and-polycystic-ovary-syndrome-pcos-100605146",false,"NCT07158723","Protein and Polycystic Ovary Syndrome (PCOS)","Assessing the Role of Higher Protein Diets in Managing Metabolic Complications of Polycystic Ovary Syndrome (PCOS)","Inclusion Criteria:\n\n* Females ages 18-50 years\n* Confirmed diagnosis of PCOS\n* Body mass index (BMI) between 18.5 and 35 kg\u002Fm2\n* Stable body weight for at least 3 months (+ 5 pounds)\n* Willingness to consume both plant- and animal-based protein meals\n\nExclusion Criteria:\n\n* Smoking or use of nicotine products\n* Smoking, vaping, and\u002For use of marijuana products\n* More than 4 alcoholic beverages per week\n* Food allergies or dietary restrictions incompatible with test meals\n* Diagnosed diabetes (type 1 or 2) or other preexisting chronic disease(s).\n* Use of medications that interfere with study outcomes (e.g., metformin, GLP-1 agonists, etc.)\n* Consumption of more than 0.8 g\u002Fprotein\u002Fkg body weight\n* Underweight\n* Taking nutritional supplements",true,"FEMALE","18 Years","50 Years",{"count":86,"type":87},60,"ESTIMATED","INTERVENTIONAL",[90],"NA","Polycystic ovary syndrome (PCOS) is a significant public health problem and is one of the most common hormonal disturbances affecting women of reproductive age. Women with PCOS are often insulin resistant, increasing their risk for cardiometabolic health problems (e.g., type 2 diabetes, heart disease, high blood pressure, sleep apnea, anxiety, depression, and stroke) especially if they are overweight. Lifestyle modifications, including dietary changes and regular physical activity, may alleviate metabolic dysfunction in women with PCOS and are often the first line of management for patients with PCOS. Several studies have identified protein as a key nutrient for regulation of energy balance, maintenance of skeletal muscle mass, and improving cardiometabolic health across the lifespan. However, the effect of increased protein intake (30% of total energy intake) on cardiometabolic health in women with PCOS has not been well-defined and mechanisms for these effects have not been identified.\n\nThere is an evident need for well-designed, randomized controlled trials evaluating the efficacy of increased protein intake in women with PCOS on markers of cardiometabolic health. Preliminary data from collaborative projects with the investigators on this proposal suggest that increasing protein in the diet has the potential to improve markers of cardiometabolic health, potentially through improvements in body composition and\u002For changes in cortisol, energy metabolism, inflammation, and neurological regulators",[93],"Polycystic Ovary Syndrome (PCOS)",[95,96,97,98,99,100],"PCOS","polycystic ovary syndrome","protein","women","wellbeing","metabolism","2025-09-02",{"date":103,"type":104},"2025-09-08","ACTUAL",{"date":106,"type":104},"2025-08-01",{"date":108,"type":87},"2027-12-03",{"name":5,"class":6},2]