[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611886":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":35,"centralContacts":39,"locations":44,"responsibleParty":62,"collaborators":64,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":28,"eligibilityCriteria":74,"healthyVolunteers":75,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":28,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":28,"overallStatus":46,"whyStopped":28,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"University of Georgia","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"CSO-30","EXPERIMENTAL","Participants are given foods enriched with cottonseed oil and instructed on how to substitute provided study foods into usual diet to maintain caloric balance.",[13],"Other: CSO-30",{"label":15,"type":10,"description":11,"interventionNames":16},"CSO-20",[17],"Other: CSO-20",{"label":19,"type":20,"description":21,"interventionNames":22},"Control","PLACEBO_COMPARATOR","Participants are given foods void of cottonseed oil and instructed on how to substitute provided study foods into usual diet to maintain caloric balance.",[23],"Other: Control",[25,29,32],{"type":6,"name":9,"description":26,"armGroupLabels":27,"otherNames":28},"Participants are provided a breakfast shake and snack to consume 3 times per week that meets 30% of participant's daily estimated energy needs as cottonseed oil for 56 days.",[9],null,{"type":6,"name":15,"description":30,"armGroupLabels":31,"otherNames":28},"Participants are provided a breakfast shake and snack to consume 3 times per week that meets 20% of participant's daily estimated energy needs as cottonseed oil for 56 days.",[15],{"type":6,"name":19,"description":33,"armGroupLabels":34,"otherNames":28},"Participants are provided a breakfast shake and snack to consume 3 times per week that does not contain cottonseed oil, but does contain thickened water for blinding purposes, for 56 days.",[19],[36],{"name":37,"affiliation":5,"role":38},"Jamie Cooper, PhD","PRINCIPAL_INVESTIGATOR",[40],{"name":37,"role":41,"phone":42,"phoneExt":28,"email":43},"CONTACT","706-542-4378","jamie.cooper@uga.edu",[45],{"facility":5,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"RECRUITING","Athens","Georgia","30602","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-83.37794,33.96095,{"lat":56,"lon":55},[59,61],{"name":60,"role":41,"phone":42,"phoneExt":28,"email":43},"Jamie A Cooper, PhD",{"name":60,"role":38,"phone":28,"phoneExt":28,"email":28},{"type":38,"investigatorFullName":37,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"Professor, Department Head of Kinesiology, Director of UGA Obesity Initiative",[65],{"name":66,"class":67},"Cotton Incorporated","UNKNOWN","100611886","intermittent-cottonseed-oil-consumption-100611886",false,"NCT07246408","Intermittent Cottonseed Oil Consumption","Intermittent Cottonseed Oil Consumption on Cardiovascular Disease Risk Reduction","Inclusion Criteria:\n\n* 25-75 year-old men and women at increased risk for cardiovascular disease. Increased risk for cardiovascular disease will be defined by either elevated cholesterol profiles -or- overweight\u002Fobesity.\n* Elevated cholesterol profiles will be defined as:\n* \"Borderline High\" and\u002For \"at risk\" in two of more of the following variables (total cholesterol: 180-239 mg\u002FdL, LDL cholesterol 110-159 mg\u002FdL, triglycerides 130-199 mg\u002FdL) --or--\n* \"High\" in total cholesterol (240 mg\u002FdL and higher), LDL (160 mg\u002FdL or higher), or triglycerides (between 200-350 mg\u002FdL).\n\nExclusion Criteria:\n\n* Probable familial hypercholesterolemia, defined by: total cholesterol greater than 290 mg\u002FdL or LDL levels greater than 190 mg\u002FdL plus a family history of myocardial infarction (MI) before 50 years of age in a 2nd-degree relative or below age 60 in a 1st-degree relative.\n* Women on hormone replacement therapy less than 2 years.\n* Women who are pregnant or nursing\u002Fbreastfeeding\n* individuals who regularly exercise more than 3h\u002Fw\n* weight gain or loss of more than 5% body weight in the past 3 months\n* plans to begin a weight loss\u002Fexercise regimen during the trial\n* history of medical or surgical events that could affect digestion or swallowing\n* gastrointestinal surgeries, conditions, or disorders\n* any chronic diseases (including moderate to severe asthma, chronic lung disease, and kidney disease),\n* metabolic disease\n* atherosclerosis\n* previous MI or stroke\n* cancer\n* fasting blood glucose levels greater than 126 mg\u002FdL\n* blood pressure greater than 180\u002F120 mmHg\n* medication use affecting digestion, absorption, or metabolism (e.g. thyroid meds), lipid-lowering medications, medications for diabetes, steroid\u002Fhormone therapies, or current antibiotic cycles\n* medically prescribed or special diets\n* Food allergies (specific to the foods in the study, including soy, dairy, gluten, Yellow No. 5, cottonseed oil, palm oil, and coconut oil)\n* fish oil supplements\n* excessive alcohol use (greater than 3 drinks\u002Fday for men; greater than 2 drinks\u002Fday for women)\n* tobacco or nicotine use\n* underweight BMI (\\\u003C18.5 kg\u002Fm²)",true,"ALL","25 Years","75 Years",{"count":80,"type":81},75,"ESTIMATED","INTERVENTIONAL",[84],"NA","Cardiovascular disease risk factors, including higher BMIs and poor cholesterol profiles, are on the rise and contribute to the United States' growing disease burden. Cottonseed oil (CSO) is found readily in the food supply, and the investigator's previous studies have demonstrated that incorporating CSO into the diet is sufficient to improve fasting and postprandial blood lipids and other markers of chronic disease risk in both healthy and at-risk populations. This study aims to examine the impact of intermittent CSO consumption at different doses (consumed three times per week (3x\u002Fwk)) on changes in fasting and postprandial lipid metabolism\u002Fblood lipids and markers of chronic disease risk.\n\nThe specific aims are: \\*Examine the impact of intermittent CSO consumption (3x\u002Fweek) at two different doses on fasting and postprandial lipids. \\*Examine the impact of intermittent CSO consumption (3x\u002Fweek) at two different doses on other markers of chronic disease risk.\n\nParticipants will be asked to:\n\n\\*Consume provided meal replacement shakes and snacks 3 times per week for 56 days. \\*Attend three bi-weekly (every other week) short visits for fasting blood draws, body measurements, and collection of the next two weeks' study materials. \\*Attend two longer (5.5h) testing visits, which include eating a standardized breakfast meal and having blood drawn periodically before and after breakfast.\n\nResearchers will compare CSO-30, CSO-20, and Control groups (receiving no oil) to see if intermittent CSO consumption imparts the same health benefits as previously shown with daily doses of CSO.",[87,88,89],"Dyslipidemia","Overweight and Obesity","Nutrition, Healthy","2026-01-21",{"date":92,"type":93},"2026-01-23","ACTUAL",{"date":95,"type":93},"2026-01-16",{"date":97,"type":81},"2029-05",{"name":5,"class":6},1]