[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100532735":3},{"organization":4,"outcomesModule":7,"designInfo":54,"detailedDescription":64,"studyPopulation":57,"armGroups":65,"interventions":83,"overallOfficials":57,"centralContacts":96,"locations":106,"responsibleParty":125,"collaborators":129,"id":133,"slug":57,"hasResults":134,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":57,"eligibilityCriteria":138,"healthyVolunteers":139,"sex":140,"minAge":141,"maxAge":142,"enrollmentInfo":143,"targetDuration":57,"studyType":146,"phases":147,"briefSummary":149,"conditions":150,"keywords":57,"overallStatus":109,"whyStopped":57,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":161},{"fullName":5,"class":6},"Penn State University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":47},[9],{"measure":10,"description":11,"timeFrame":12},"LDL-cholesterol concentration","Assessed from fasting blood draw expressed in mg\u002FdL. LDL-cholesterol will be measured directly via enzymatic assay. The mean of the LDL-cholesterol values from day 1 and day 2 testing will be used for analysis.","4 weeks",[14,17,19,21,24,27,29,32,35,38,41,44],{"measure":15,"description":16,"timeFrame":12},"Triglycerides concentration","Assessed from fasting blood draw expressed in mg\u002FdL",{"measure":18,"description":16,"timeFrame":12},"Total Cholesterol concentration",{"measure":20,"description":16,"timeFrame":12},"HDL-cholesterol concentration",{"measure":22,"description":23,"timeFrame":12},"Particle Size and Number of LDL, HDL, VLDL and Chylomicrons","Measured via Nuclear Magnetic Resonance",{"measure":25,"description":26,"timeFrame":12},"Central Systolic and Diastolic Blood Pressure","Blood pressure measured assessed using a SphymoCor Xcel (Atcor Medical)",{"measure":28,"description":26,"timeFrame":12},"Brachial Systolic and Diastolic Blood Pressure",{"measure":30,"description":31,"timeFrame":12},"Carotid-Femoral Pulse Wave Velocity","A measure of arterial stiffness assessed using a SphymoCor Xcel (Atcor Medical).\n\nExpressed in meters\u002Fsecond.",{"measure":33,"description":34,"timeFrame":12},"Fasting Serum Insulin concentration","Serum insulin levels assessed in a fasting blood draw and expressed in micro IU\u002FmL",{"measure":36,"description":37,"timeFrame":12},"Fasting Plasma Glucose concentration","Glucose assessed in a fasting blood draw and expressed in mg\u002FdL",{"measure":39,"description":40,"timeFrame":12},"Fasting Serum Fructosamine concentration","Fructosamine assessed in a fasting blood draw and expressed in micro IU\u002FmL",{"measure":42,"description":43,"timeFrame":12},"Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)","Calculated from insulin and glucose measured from a fasting blood sample. Calculated as (insulin × glucose) \u002F 22.5",{"measure":45,"description":46,"timeFrame":12},"Dihydrosterculic acid","Dihydrosterculic acid assessed from fasting blood draw and measured using Gas-Chromatography-Mass Spectrometry",[48,51],{"measure":49,"description":50,"timeFrame":12},"Composition of the Gut Microbiota","Abundance measured using 16 s rRNA sequencing",{"measure":52,"description":53,"timeFrame":12},"Fatty acids","Fatty acid analysis of red blood cells assessed from fasting blood draw and measured using Gas Chromatography",{"allocation":55,"interventionModel":56,"interventionModelDescription":57,"primaryPurpose":58,"observationalModel":57,"timePerspective":57,"maskingInfo":59},"RANDOMIZED","CROSSOVER",null,"PREVENTION",{"masking":60,"maskingDescription":57,"whoMasked":61},"DOUBLE",[62,63],"INVESTIGATOR","OUTCOMES_ASSESSOR","This is a 3-period randomized crossover complete feeding study examining if a dietary pattern containing cottonseed oil improves lipids\u002Flipoproteins and other cardiometabolic disease risk factors to a greater extent than a fatty acid matched diet devoid of cottonseed oil and a diet lower in polyunsaturated fatty acids (PUFA) and saturated fatty acids (SFA), but with a matched PUFA:SFA ratio",[66,72,78],{"label":67,"type":68,"description":69,"interventionNames":70},"Healthy Diet + Cottonseed Oil (CSOD)","EXPERIMENTAL","Healthy dietary pattern containing 40g\u002Fday\u002F2000 kcal of cottonseed oil (CSO)",[71],"Other: Healthy Dietary Pattern with Cottonseed Oil",{"label":73,"type":74,"description":75,"interventionNames":76},"Healthy Diet + Fatty Acid-Matched Plant Oils (FAMD)","ACTIVE_COMPARATOR","Healthy dietary pattern containing 40g\u002Fday\u002F2000 kcal of a blend of plant oils comprising a fatty acid profile that matches the CSOD but devoid of CSO",[77],"Other: Healthy Dietary Pattern with Fatty Acid-Matched Plant Oils",{"label":79,"type":74,"description":80,"interventionNames":81},"Healthy Diet + PUFA:SFA Ratio-Matched Plant Oil (P:S-MD)","Healthy dietary pattern containing 40g\u002Fday\u002F2000 kcal of plant oil that is lower in polyunsaturated fatty acids (PUFA) and saturated fatty acids (SFA) than the CSOD, but with a matched PUFA:SFA ratio and devoid of CSO.",[82],"Other: Healthy Dietary Pattern with PUFA:SFA Ratio-Matched Plant Oil",[84,88,92],{"type":6,"name":85,"description":86,"armGroupLabels":87,"otherNames":57},"Healthy Dietary Pattern with Cottonseed Oil","Cottonseed Oil",[67],{"type":6,"name":89,"description":90,"armGroupLabels":91,"otherNames":57},"Healthy Dietary Pattern with Fatty Acid-Matched Plant Oils","Plant oil blend fatty acid matched",[73],{"type":6,"name":93,"description":94,"armGroupLabels":95,"otherNames":57},"Healthy Dietary Pattern with PUFA:SFA Ratio-Matched Plant Oil","Plant oil with matched PUFA to SFA ratio",[79],[97,102],{"name":98,"role":99,"phone":100,"phoneExt":57,"email":101},"Kristina Petersen, PhD","CONTACT","814-865-7206","kup63@psu.edu",{"name":103,"role":99,"phone":104,"phoneExt":57,"email":105},"Stacey Meily","814-863-8622","sas117@psu.edu",[107],{"facility":108,"status":109,"city":110,"state":111,"zip":112,"country":113,"countryCode":114,"cosmosGeoPoint":115,"geoPoint":120,"contacts":121},"The Pennylvania State University","RECRUITING","University Park","Pennsylvania","16802","United States","US",{"type":116,"coordinates":117},"Point",[118,119],-77.85639,40.80201,{"lat":119,"lon":118},[122],{"name":57,"role":99,"phone":123,"phoneExt":57,"email":124},"1-866-778-3438","DCHLab@psu.edu",{"type":126,"investigatorFullName":127,"investigatorTitle":128,"investigatorAffiliation":5,"oldNameTitle":57,"oldOrganization":57},"PRINCIPAL_INVESTIGATOR","Kristina Petersen PhD, APD, FAHA","Associate Professor",[130],{"name":131,"class":132},"Cotton Incorporated","UNKNOWN","100532735",false,"NCT06216678","The Effects of Healthy Diets With Plant Oils on Heart and Metabolic Health","The Effects of Healthy Diets With Plant Oils on Heart and Metabolic Health: A Randomized, Crossover, Controlled-feeding Study","Inclusion Criteria:\n\n* LDL-C ≥100 mg\u002FdL and ≤190 mg\u002FdL\n* BMI of 25-40 kg\u002Fm2\n* Blood pressure \\\u003C140\u002F90 mmHg\n* Fasting blood glucose \\\u003C126 mg\u002FdL\n* Fasting triglycerides \\\u003C350 mg\u002FdL\n* ≤10% change in body weight for 6 months prior to enrollment\n\nExclusion Criteria:\n\n* Type 1 or type 2 diabetes or fasting blood glucose ≥126 mg\u002FdL\n* Prescription of anti-hypertensive, lipid lowering or glucose lowering drugs\n* Intake of supplements that affect the outcomes of interest and unwilling to cease during the study period\n* Diagnosed liver, kidney, or autoimmune disease\n* Prior cardiovascular event (e.g., stroke, heart attack)\n* Current pregnancy or intention of pregnancy within the next 6 months\n* Lactation within prior 6 months\n* Follows a vegetarian or vegan diet\n* Food allergies\u002Fintolerance\u002Fsensitives\u002Fdislikes of foods included in the study menu\n* Antibiotic use within the prior 1 month\n* Oral steroid use within the prior 1 month\n* Use of tobacco or nicotine containing products with in the past 6 months\n* Cancer any site within the past 10 years (eligible if ≥10 years without recurrence) or non-melanoma skin cancer with in the past 5 years (eligible if ≥5 years without recurrence)\n* Participation in another clinical trial within 30 days of baseline\n* Currently following a restricted or weight loss diet\n* Prior bariatric surgery\n* Intake of \\>14 alcoholic drinks\u002Fweek and\u002For lack of willingness to consume a maximum of two standard drinks per week while enrolled in the study and\u002For not willing to avoid alcohol consumption for 48 hour prior to test visits",true,"ALL","25 Years","60 Years",{"count":144,"type":145},52,"ESTIMATED","INTERVENTIONAL",[148],"NA","This study will examine the effect of a healthy diet containing cottonseed oil compared to healthy diets containing other commonly consumed plant oils on biomarkers of heart and metabolic health after 4 weeks.",[151],"Cardiovascular Diseases","2026-01-29",{"date":154,"type":155},"2026-02-02","ACTUAL",{"date":157,"type":155},"2024-09-09",{"date":159,"type":145},"2027-12",{"name":5,"class":6},1]