[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06216678":3,"trial-entities:NCT06216678":143,"trial-summary:NCT06216678":147},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":44,"secondary_outcomes":49,"sex":83,"minimum_age":84,"maximum_age":85,"healthy_volunteers":86,"eligibility_criteria":87,"std_ages":114,"locations":116,"central_contacts":131,"overall_officials":140,"references":141,"see_also_links":142},"NCT06216678","POS","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","RECRUITING","2027-12","2026-01","2026-02-02","2024-09-09","Penn State University","OTHER",false,"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.","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",[19],"Cardiovascular Diseases",[],"INTERVENTIONAL","PREVENTION",[24],"NA",{"count":26,"type":27},52,"ESTIMATED",[29,34,39],{"type":14,"name":30,"description":31,"armGroupLabels":32},"Healthy Dietary Pattern with Cottonseed Oil","Cottonseed Oil",[33],"Healthy Diet + Cottonseed Oil (CSOD)",{"type":14,"name":35,"description":36,"armGroupLabels":37},"Healthy Dietary Pattern with Fatty Acid-Matched Plant Oils","Plant oil blend fatty acid matched",[38],"Healthy Diet + Fatty Acid-Matched Plant Oils (FAMD)",{"type":14,"name":40,"description":41,"armGroupLabels":42},"Healthy Dietary Pattern with PUFA:SFA Ratio-Matched Plant Oil","Plant oil with matched PUFA to SFA ratio",[43],"Healthy Diet + PUFA:SFA Ratio-Matched Plant Oil (P:S-MD)",[45],{"measure":46,"description":47,"timeFrame":48},"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",[50,53,55,57,60,63,65,68,71,74,77,80],{"measure":51,"description":52,"timeFrame":48},"Triglycerides concentration","Assessed from fasting blood draw expressed in mg\u002FdL",{"measure":54,"description":52,"timeFrame":48},"Total Cholesterol concentration",{"measure":56,"description":52,"timeFrame":48},"HDL-cholesterol concentration",{"measure":58,"description":59,"timeFrame":48},"Particle Size and Number of LDL, HDL, VLDL and Chylomicrons","Measured via Nuclear Magnetic Resonance",{"measure":61,"description":62,"timeFrame":48},"Central Systolic and Diastolic Blood Pressure","Blood pressure measured assessed using a SphymoCor Xcel (Atcor Medical)",{"measure":64,"description":62,"timeFrame":48},"Brachial Systolic and Diastolic Blood Pressure",{"measure":66,"description":67,"timeFrame":48},"Carotid-Femoral Pulse Wave Velocity","A measure of arterial stiffness assessed using a SphymoCor Xcel (Atcor Medical).\n\nExpressed in meters\u002Fsecond.",{"measure":69,"description":70,"timeFrame":48},"Fasting Serum Insulin concentration","Serum insulin levels assessed in a fasting blood draw and expressed in micro IU\u002FmL",{"measure":72,"description":73,"timeFrame":48},"Fasting Plasma Glucose concentration","Glucose assessed in a fasting blood draw and expressed in mg\u002FdL",{"measure":75,"description":76,"timeFrame":48},"Fasting Serum Fructosamine concentration","Fructosamine assessed in a fasting blood draw and expressed in micro IU\u002FmL",{"measure":78,"description":79,"timeFrame":48},"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":81,"description":82,"timeFrame":48},"Dihydrosterculic acid","Dihydrosterculic acid assessed from fasting blood draw and measured using Gas-Chromatography-Mass Spectrometry","ALL","25 Years","60 Years",true,{"inclusion":88,"exclusion":95,"raw_text":113},[89,90,91,92,93,94],"LDL-C ≥100 mg\u002FdL and ≤190 mg\u002FdL","BMI of 25-40 kg\u002Fm2","Blood pressure \\\u003C140\u002F90 mmHg","Fasting blood glucose \\\u003C126 mg\u002FdL","Fasting triglycerides \\\u003C350 mg\u002FdL","≤10% change in body weight for 6 months prior to enrollment",[96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112],"Type 1 or type 2 diabetes or fasting blood glucose ≥126 mg\u002FdL","Prescription of anti-hypertensive, lipid lowering or glucose lowering drugs","Intake of supplements that affect the outcomes of interest and unwilling to cease during the study period","Diagnosed liver, kidney, or autoimmune disease","Prior cardiovascular event (e.g., stroke, heart attack)","Current pregnancy or intention of pregnancy within the next 6 months","Lactation within prior 6 months","Follows a vegetarian or vegan diet","Food allergies\u002Fintolerance\u002Fsensitives\u002Fdislikes of foods included in the study menu","Antibiotic use within the prior 1 month","Oral steroid use within the prior 1 month","Use of tobacco or nicotine containing products with in the past 6 months","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)","Participation in another clinical trial within 30 days of baseline","Currently following a restricted or weight loss diet","Prior bariatric surgery","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","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",[115],"ADULT",[117],{"facility":118,"status":8,"city":119,"state":120,"zip":121,"country":122,"contacts":123,"geoPoint":128},"The Pennylvania State University","University Park","Pennsylvania","16802","United States",[124],{"role":125,"phone":126,"email":127},"CONTACT","1-866-778-3438","DCHLab@psu.edu",{"lat":129,"lon":130},40.80201,-77.85639,[132,136],{"name":133,"role":125,"phone":134,"email":135},"Kristina Petersen, PhD","814-865-7206","kup63@psu.edu",{"name":137,"role":125,"phone":138,"email":139},"Stacey Meily","814-863-8622","sas117@psu.edu",[],[],[],{"nct_id":4,"conditions":144,"biomarkers":146},[145],"Cardiovascular Disorder",[],{"nct_id":4,"found":86,"summary":148,"prompt_version":158},{"design":149,"status":150,"heading":151,"summary":152,"follow_up":153,"word_count":154,"commitments":155,"compensation":156,"drugs_mentioned":157},"This is an interventional study that will enroll 52 participants. It is a randomized crossover study, meaning participants will try different diets in a random order.","completed","Healthy Diets with Plant Oils for Heart and Metabolic Health","This study is looking at how different healthy diets, specifically those containing cottonseed oil compared to other plant oils, affect your heart and metabolic health. Researchers want to see if a healthy diet with cottonseed oil improves your LDL-cholesterol (often called \"bad\" cholesterol) more than diets with other plant oils. You might be able to join if you are between 25 and 60 years old, have LDL-cholesterol between 100 and 190 mg\u002FdL, and a BMI between 25 and 40 kg\u002Fm2. The study is currently unclear on its recruitment status and plans to enroll 52 participants. Success will be measured by changes in LDL-cholesterol after 4 weeks.","The primary endpoint, LDL-cholesterol, is measured at 4 weeks.",106,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]