[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591106":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":32,"locations":37,"responsibleParty":61,"collaborators":24,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":71,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":24,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":87,"overallStatus":39,"whyStopped":24,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Pennington Biomedical Research Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Pork Diet","EXPERIMENTAL","All participants will receive 7 days x 4 weeks of meals and snacks following a dietary pattern high in pork.",[13],"Behavioral: Pork Diet",{"label":15,"type":10,"description":16,"interventionNames":17},"Plant Diet","All participants will receive 7 days x 4 weeks of meals and snacks following a plant based diet.",[18],"Behavioral: Plant Diet",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"BEHAVIORAL","The diet will follow the Dietary Guidelines for Americans with 80% of the meat consumption per week being pork. Other animal protein (e.g., turkey, chicken, beef) will be minimized in the dietary plans (≤ 20%) so lean and processed pork are the primary protein source consumed. Within each day, \\~80% of the daily pork intake will be fresh, unprocessed lean cuts (e.g., tenderloin, loin chops, sirloin roast, flank, and rump roast) and \\~20% will be cured sources (e.g., Canadian bacon, pork sausage).",[9],null,{"type":21,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"The diet will be a Lacto-Ovo Vegetarian Diet following the Dietary Guidelines for Americans with no more than 21 oz per week of animal protein (e.g., eggs, cheese).",[15],[29],{"name":30,"affiliation":5,"role":31},"Hannah E Cabre, PhD, RDN","PRINCIPAL_INVESTIGATOR",[33],{"name":30,"role":34,"phone":35,"phoneExt":24,"email":36},"CONTACT","225-763-2826","hannah.cabre@pbrc.edu",[38],{"facility":5,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"RECRUITING","Baton Rouge","Louisiana","70808","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-91.18747,30.44332,{"lat":49,"lon":48},[52,55,56,59],{"name":53,"role":34,"phone":54,"phoneExt":24,"email":36},"Hannah E Cabre","225-763-2628",{"name":30,"role":31,"phone":24,"phoneExt":24,"email":24},{"name":57,"role":58,"phone":24,"phoneExt":24,"email":24},"Leanne M Redman, PhD","SUB_INVESTIGATOR",{"name":60,"role":58,"phone":24,"phoneExt":24,"email":24},"Catherine Champagne, PhD",{"type":62,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100591106","impact-of-lean-pork-on-endothelial-function-in-perimenopause-100591106",false,"NCT06976112","Impact of Lean Pork on Endothelial Function in Perimenopause","Effects of Lean Pork Intake on Endothelial Function and Vasomotor Symptoms in Perimenopausal Women","LEAP","Inclusion Criteria:\n\n* Are female\n* Are between 40 and 55 years of age\n* Have a BMI (a number calculated from participant height and weight) between 28 and45 kg\u002Fm2\n* Are experiencing irregular menstrual cycles but have not gone longer than 12 consecutive months without a period\n* Are experiencing severe vasomotor (menopause) symptoms\n* Are doing less than 3 hours per week of structured exercise\n* Have systolic blood pressure between 120 and 140 mmHg and\u002For diastolic blood pressure between 80 and 90 mmHg\n* Have \"sugary\" hemoglobin called hemoglobin A1c less than or equal to 6.5%\n* Are willing and able to refrain from using oral mouth wash for the duration of the study because the alcohol in mouth wash inhibits nitrate synthesis\n* Are willing and able to comply with both the study diets\n* Are willing to collect blood for future research\n* Can read, speak, and understand English\n\nExclusion Criteria:\n\n* Hysterectomy (partial or full) or oophorectomy\n* Using hormone replacement therapy use and\u002For hormonal contraception use 6 months prior to study start\n* Has systolic blood pressure ≥140 mmHg and\u002For diastolic blood pressure ≥ 90 mmHg)\n* Triglycerides ≥350 mg\u002FdL, low-density lipoprotein cholesterol (LDL-C) ≥190 mg\u002FdL, and\u002For taking a lipid-lowering medication -Diagnosed cardiovascular disease, diabetes (type 1 or 2), or endocrine- related disease (e.g. thyroid, PCOS), unstable gastrointestinal disease, kidney, liver, and\u002For pancreatic disease\n* Diagnosed cancer (except skin cancer) in the last 5 years\n* Taking \\>1 blood pressure medication and\u002For taking 1 blood pressure medication for \\\u003C3 months\n* Taking phosphodiesterase-5 inhibitors, anti-coagulants, corticosteroids, metformin, or insulin.\n* Weight change ≥6.6 pounds in the past 3 months, actively trying to lose weight, or unwilling to remain weight stable throughout the study\n* Current smoking or vaping, Binge and\u002For heavy drinker\n* Food allergies or other reasons preventing consumption of study foods with both study diets",true,"FEMALE","40 Years","55 Years",{"count":76,"type":77},30,"ESTIMATED","INTERVENTIONAL",[80],"NA","The goal of this study is to examine the impact of a diet high in fresh lean pork, compared to a plant-based diet, on cardiovascular function and vasomotor symptoms in perimenopausal women with overweight and obesity. The main questions it aims to answer are:\n\n1. How does a diet high in pork, compared to a plant-based diet, affects blood lipids, endothelial function, and blood pressure?\n2. How does a diet high in pork, compared to a plant-based diet, affects blood nitrate, cardiometabolic biomarkers, inflammatory biomarkers, and vasomotor symptoms?\n\nResearchers will compare the diet high in pork to a plant-based diet to see if pork helps improve cardiovascular and mesopause symptoms.\n\nParticipants will:\n\n* Consume both of the diets, each for 4 weeks, with a washout period between 2 and 6 weeks in between the diets trials\n* Visit the clinic 5 times with weekly meal pick ups during the diet trials\n* Undergo testing procedures including: weight and body composition, blood pressure and pulse, endothelial function using ultrasound of upper arm, microvascular blood flow, blood draws, physical activity measurements, and questionnaires.",[83,84,85,86],"Cardiovascular Outcome","Overweight and Obese Women","Perimenopausal Women","Vasomotor Symptoms (VMS)",[88,89,90,91,92,93,94,95,96],"Perimenopause","Perimenopausal","Vasomotor Symptoms","VMS","Menopause","Cardiovascular Health","Blood pressure","Pork","Vegetarian","2025-11-26",{"date":99,"type":100},"2025-11-28","ACTUAL",{"date":102,"type":100},"2025-08-01",{"date":104,"type":77},"2027-05",{"name":5,"class":6},1]