[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06382298":3,"trial-entities:NCT06382298":171,"trial-summary:NCT06382298":175},{"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":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":43,"secondary_outcomes":78,"sex":110,"minimum_age":111,"maximum_age":112,"healthy_volunteers":113,"eligibility_criteria":114,"std_ages":144,"locations":147,"central_contacts":164,"overall_officials":167,"references":169,"see_also_links":170},"NCT06382298","PROJECT00009332","Cottonseed Oil Versus Matched PUFA Effects","Health Effects of Cottonseed Oil Versus Matched Composition Diets in Humans","RECRUITING","2028-05","2025-08","2025-08-17","2024-08-31","University of Georgia","OTHER",false,"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 cholesterol profile and improve postprandial lipid and\u002For glycemic responses in both healthy, and at-risk populations. This study aims to compare CSO to a fatty acid composition-matched diet, on changes in fasting and postprandial lipid metabolism and markers of chronic disease risk.\n\nThe specific aims are:\n\n* Examine the impact of CSO vs. PUFA on fasting and postprandial lipids.\n* Examine the impact of CSO on other markers of chronic disease risk.\n\nParticipants will be asked to:\n\n* Consume provided meal replacement shakes daily for 28-days.\n* Attend three weekly short visits for fasting blood draws, body measurements, and collect the next week of study materials,\n* 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 vs. PUFA and control groups (receiving a mixture of oils) to see if CSO is unique in imparting health benefits when compared with similar matched oil diets.","Accounting for nearly 1 in every 4 deaths in the U.S., cardiovascular disease (CVD) is the leading cause of death for adults. One risk factor for CVD is hypercholesterolemia which can double the risk for this disease. Cottonseed oil is a rich source of poly-unsaturated fatty acids (PUFAs). Despite having a relatively high amount of saturated fatty acids, preliminary studies demonstrate that incorporating CSO into a diet is sufficient to reduce blood lipid profiles and select postprandial measures of metabolism. These improvements in lipid metabolism may be due to the general fatty acid (FA) composition of CSO; however, evidence shows that a fatty acid unique to CSO, dihydrosterculic acid (DHSA), may be responsible for some, if not all, the positive lipid lowering effects.\n\nThis prospective clinical study is a double-blinded, randomized control trial in adults at increased risk for cardiovascular disease (poor cholesterol profiles or overweight\u002Fobesity). There are three diet interventions: CSO (20% energy needs from CSO), matched-PUFA (20% energy needs from non-CSO matched PUFA sources), and Control (20% of energy needs from control oil mixture representative of the average fatty acid composition consumed by U.S. adults). The study protocol consists of a 28-day intervention where participants are provided breakfast shakes that contain a different oil, or mixture of oils, depending on the participant's random group assignment.\n\nThere are a total of 6 testing visits: screening (v0), pre-intervention (v1), 3 weekly short visits (v2, v3, v4), and post-intervention (v5).\n\nAt screening (v0), qualification is confirmed based on anthropometrics and fasting blood draw, which is analyzed for a cholesterol panel and blood glucose. Additionally, energy requirements are estimated at this visit for use in the diet intervention.\n\nAt v1, participants will have anthropometrics measured, including body composition by dual-energy x-ray absorptiometry (DXA). Fasting and postprandial blood draws for a 5h period will occur following a high saturated-fat meal challenge which delivers 35% of the participant's estimated energy needs.\n\n28-day dietary intervention: Participants will consume a daily shake corresponding to the participant's randomly assigned group. The ingredients for the breakfast shakes are identical between groups, the only difference being the composition of assigned oil provided. The breakfast shakes are portioned based on individual energy needs as estimated at v0.\n\nParticipants return weekly (v2, v3, v4), to return study materials and collect shakes for the next week. At these weekly visits, participants also have a fasting blood draw, body measures, and consume the daily breakfast shake in the lab.\n\nAt the end of the 28-day dietary intervention, participants return for v5, where all procedures from v1 are repeated.\n\nAs decided a priori, we will complete a per protocol analysis.\n\nThe investigators hypothesize that CSO will improve the proposed overall health outcomes and markers of chronic disease risk when compared with the matched PUFA and control groups.",[19,20,21],"Dyslipidemia","Overweight and Obesity","Nutrition, Healthy",[],"INTERVENTIONAL","PREVENTION",[26],"NA",{"count":28,"type":29},90,"ESTIMATED",[31,35,39],{"type":14,"name":32,"description":33,"armGroupLabels":34},"COTTONSEED OIL","Participants are provided a breakfast shake that meets 20% of participant's daily estimated energy needs as cottonseed oil for 28 days.",[32],{"type":14,"name":36,"description":37,"armGroupLabels":38},"MATCHED PUFA DIET","Participants are provided a breakfast shake that meets 20% of participant's daily estimated energy needs from oils with similar fatty acid composition as CSO for 28 days.",[36],{"type":14,"name":40,"description":41,"armGroupLabels":42},"CONTROL","Participants are provided a breakfast shake that meets 20% of participant's daily estimated energy needs as a mixture of oils that match the average American fat intake for 28 days.",[40],[44,48,51,54,57,60,63,66,69,72,75],{"measure":45,"description":46,"timeFrame":47},"Change in fasting serum lipoprotein and cholesterol concentrations","The concentration of fasting serum total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, apolipoprotein B (mg\u002FdL)","baseline, 4 weeks",{"measure":49,"description":50,"timeFrame":47},"Change in fasting and postprandial plasma triglyceride concentrations","The concentration of plasma triglycerides before and after the high saturated fat meal challenge at both pre-and post-intervention visits (mg\u002FdL)",{"measure":52,"description":53,"timeFrame":47},"Change in fasting and postprandial plasma non-esterified fatty acid (NEFA) concentrations","The concentration of plasma NEFAs before and after the high saturated fat meal challenge at both pre- and post- intervention visits (mEq\u002FL)",{"measure":55,"description":56,"timeFrame":47},"Change in fasting and postprandial plasma appetite control hormones concentrations","The concentration of plasma appetite control hormones before and after the high saturated fat meal challenge at both pre- and post-intervention visits. Appetite control hormones include cholecystokinin (CCK), Peptide YY (PYY), Ghrelin (pg\u002FmL)",{"measure":58,"description":59,"timeFrame":47},"Change in fasting and postprandial subjective feelings related to appetite","Visual analog scale ratings of feelings related to appetite before and after the high saturated fat meal challenge, and for the remainder of the day, at both pre- and post- intervention visits. Subjective feelings of hunger, fullness, desire to eat, prospective consumption and a composite appetite score are measured by visual analog scales (mm).",{"measure":61,"description":62,"timeFrame":47},"Change in fasting and postprandial plasma Malondialdehyde (MDA)","The concentration of MDA before and after the high saturated fat meal challenge at both pre- and post- intervention visits (nmol\u002FmL).",{"measure":64,"description":65,"timeFrame":47},"Change in fasting and postprandial plasma total antioxidant capacity","Total antioxidant capacity before and after the high saturated fat meal challenge at both pre- and post- intervention visits (U\u002FmL).",{"measure":67,"description":68,"timeFrame":47},"Change in fasting inflammatory cytokine concentrations","The concentration of interleukin-1 beta, C reactive protein, tumor-necrosis factor-alpha, and interleukin-6 at fasting at both pre-and post-intervention visits (pg\u002FmL).",{"measure":70,"description":71,"timeFrame":47},"Change in fasting plasma markers of coagulation potential","The concentration of plasminogen activator inhibitor-1, and tissue factor at fasting for both pre- and post- intervention visits (pg\u002FmL)",{"measure":73,"description":74,"timeFrame":47},"Change in fasting and postprandial plasma angiopoietin-like (ANGPTL) proteins","The concentration of ANGPTL 3, ANGPTL 4 and ANGPTL 8 before and after the high saturated fat meal challenge at both pre- and post- intervention visits (ng\u002FmL)",{"measure":76,"description":77,"timeFrame":47},"Desaturation index","Measurement of fatty acid concentrations for fasting and post-prandial plasma (ratio of unsaturated to saturated fatty acids)",[79,83,86,89,92,95,98,101,104,107],{"measure":80,"description":81,"timeFrame":82},"Change in fasting serum hepatic enzymes","Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Gamma-Glutamyl Transferase (GGT) (U\u002FL)","Baseline, 4 weeks",{"measure":84,"description":85,"timeFrame":82},"Change in fasting serum hepatic proteins","Total protein and albumin (g\u002FdL)",{"measure":87,"description":88,"timeFrame":47},"Change in fasting serum lipoprotein particle numbers","Number of particles of low density lipoproteins (LDL), LDL small, HDL large, LDL medium, lipoprotein (a) (nmol\u002FL)",{"measure":90,"description":91,"timeFrame":82},"Change in fasting serum bilirubin","Total bilirubin, direct bilirubin and indirect bilirubin (mg\u002FdL)",{"measure":93,"description":94,"timeFrame":47},"Change in fasting and postprandial plasma insulin concentrations","The concentration of plasma insulin before and after the high saturated fat meal challenge at both pre- and post- intervention visits (uU\u002FmL)",{"measure":96,"description":97,"timeFrame":82},"Change in fasting and postprandial plasma glucose concentrations","The concentration of plasma glucose before and after the high saturated fat meal challenge at both pre- and post- intervention visits (mg\u002FdL)",{"measure":99,"description":100,"timeFrame":47},"Change in additional fasting plasma inflammatory cytokine concentrations","The concentration of monocyte chemoattractant protein-1, and interleukin-10, at fasting for both pre- and post-intervention visits (pg\u002FmL)",{"measure":102,"description":103,"timeFrame":47},"Change in additional fasting plasma markers of coagulation potential","The concentration of Von Willebrand factor, tissue factor pathway inhibitor, fibrinogen and D-dimer, at fasting for both pre- and post- intervention visits (pg\u002FmL)",{"measure":105,"description":106,"timeFrame":47},"Change in acute dietary intake","One-day food logs will be used to record all foods and beverages consumed on testing days",{"measure":108,"description":109,"timeFrame":47},"Change in fasting insulin resistance metrics","Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) and homeostatic model assessment for beta cell function (HOMA-B) will be calculated from fasting insulin and glucose measures before and after the 28-day intervention.","ALL","25 Years","75 Years",true,{"inclusion":115,"exclusion":120,"raw_text":143},[116,117,118,119],"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.","Elevated cholesterol profiles will be defined as:","\"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--","\"High\" in total cholesterol (240 mg\u002FdL and higher), LDL (160 mg\u002FdL or higher), or triglycerides (between 200-350 mg\u002FdL).",[121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142],"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.","Women on hormone replacement therapy less than 2 years.","Women who are pregnant","individuals who regularly exercise more than 3h\u002Fw","weight gain or loss of more than 5% body weight in the past 3 months","plans to begin a weight loss\u002Fexercise regimen during the trial","history of medical or surgical events that could affect digestion or swallowing","gastrointestinal surgeries, conditions, or disorders","any chronic diseases (including moderate to severe asthma, chronic lung disease, and kidney disease),","metabolic disease","atherosclerosis","previous MI or stroke","cancer","fasting blood glucose levels greater than 126 mg\u002FdL","blood pressure greater than 180\u002F120 mmHg","medication use affecting digestion an absorption, metabolism (e.g. thyroid meds), lipid-lowering medications, medications for diabetes, steroid\u002Fhormone therapies, or current antibiotic cycles","medically prescribed or special diets","Food allergies (specific to the foods in the study, including wheat, dairy, and cottonseed oil)","fish oil supplements","excessive alcohol use (greater than 3 drinks\u002Fday for men; greater than 2 drinks\u002Fday for women)","tobacco or nicotine use","underweight BMI (\\\u003C18.5 kg\u002Fm²)","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\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\n* \"High\" in total cholesterol (240 mg\u002FdL and higher), LDL (160 mg\u002FdL or higher), or triglycerides (between 200-350 mg\u002FdL).\n\nOverweight\u002Fobesity will be defined by body mass index \\>25 kg\u002Fm².\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\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 an absorption, 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 wheat, dairy, and cottonseed 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)",[145,146],"ADULT","OLDER_ADULT",[148],{"facility":13,"status":8,"city":149,"state":150,"zip":151,"country":152,"contacts":153,"geoPoint":161},"Athens","Georgia","30602","United States",[154,159],{"name":155,"role":156,"phone":157,"email":158},"Jamie A Cooper, Ph.D.","CONTACT","706-542-4378","jamie.cooper@uga.edu",{"name":155,"role":160},"PRINCIPAL_INVESTIGATOR",{"lat":162,"lon":163},33.96095,-83.37794,[165],{"name":166,"role":156,"phone":157,"email":158},"Jamie Cooper, PhD",[168],{"name":166,"affiliation":13,"role":160},[],[],{"nct_id":4,"conditions":172,"biomarkers":174},[19,173],"Overweight",[],{"nct_id":4,"found":113,"summary":176,"prompt_version":186},{"design":177,"status":178,"heading":179,"summary":180,"follow_up":181,"word_count":182,"commitments":183,"compensation":184,"drugs_mentioned":185},"This is a double-blinded, randomized control trial. It involves three different diet interventions and plans to enroll 90 participants.","completed","Cottonseed Oil and Heart Health Study","This study is looking at how different oils in your diet affect your heart health, specifically your cholesterol levels. Researchers want to see if cottonseed oil (CSO) can improve cholesterol and other fat levels in your blood. You might be able to join if you are between 25 and 75 years old and have an increased risk for heart disease, such as high cholesterol or being overweight\u002Fobese. Participants will receive a breakfast shake for 28 days containing either cottonseed oil, a matched polyunsaturated fatty acid (PUFA) diet, or a control oil mixture. The study will measure changes in your cholesterol and other fat levels in your blood before and after the 28 days. The study aims to enroll 90 people.","Your blood levels will be measured at baseline and again after 4 weeks.",120,"You would receive a breakfast shake daily for 28 days. Blood tests will be done at the beginning and after 4 weeks.","Not stated in the trial record.",[32,40],"v2"]