[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07401888":3,"trial-entities:NCT07401888":106,"trial-summary:NCT07401888":109},{"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":14,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":38,"secondary_outcomes":70,"sex":71,"minimum_age":72,"maximum_age":73,"healthy_volunteers":15,"eligibility_criteria":74,"std_ages":78,"locations":81,"central_contacts":95,"overall_officials":100,"references":104,"see_also_links":105},"NCT07401888","25-010619","A Study Of Milk Consumption In Metabolic Syndrome","Milk Consumption On Cardiovascular Risk Factors In Metabolic Syndrome","RECRUITING","2028-02","2026-04","2026-04-16","2026-04-13","Mayo Clinic","OTHER",false,"The primary purpose of this study is to determine the impact of whole-fat dairy consumption on cardiovascular and metabolic risk factors and peripheral vascular function in adults with metabolic syndrome.",null,[19],"Metabolic Syndrome",[],"INTERVENTIONAL",[23],"NA",{"count":25,"type":26},40,"ESTIMATED",[28,34],{"type":14,"name":29,"description":30,"armGroupLabels":31},"Full-fat diet","The patients will follow a full-fat, isoenergetic diet consisting of 45% carbohydrates, 20% protein, and 35% fat for a duration of three weeks.",[32,33],"Full-fat diet first then Low-fat diet","Low-fat diet first then Full-fat diet",{"type":14,"name":35,"description":36,"armGroupLabels":37},"Low-fat diet","The patients will follow a low-fat, isoenergetic diet consisting of 45% carbohydrates, 20% protein, and 35% fat for a duration of three weeks.",[32,33],[39,43,46,49,52,55,58,61,64,67],{"measure":40,"description":41,"timeFrame":42},"Change in Total Cholesterol","Total Cholesterol will be measured by a blood sample and reported as mg\u002FdL","Baseline, Week 3, Week 5, Week 8",{"measure":44,"description":45,"timeFrame":42},"Change in HDL-C (High Density Lipoprotein Cholesterol)","High Density Lipoprotein Cholesterol will be measured by a blood sample and reported as mg\u002FdL",{"measure":47,"description":48,"timeFrame":42},"Change in LDL-C (Low Density Lipoprotein Cholesterol)","Low Density Lipoprotein Cholesterol will be measured by a blood sample and reported as mg\u002FdL",{"measure":50,"description":51,"timeFrame":42},"Change in Triglycerides","Triglycerides will be measured by a blood sample and reported as mg\u002FdL",{"measure":53,"description":54,"timeFrame":42},"Change in Blood Glucose","Blood Glucose will be measured by a blood sample and reported as mg\u002FdL",{"measure":56,"description":57,"timeFrame":42},"Change in Hemoglobin A1c","Hemoglobin is a protein within red blood cells. As glucose enters the bloodstream, it binds to hemoglobin, or glycates. The more glucose that enters the bloodstream, the higher the amount of glycated hemoglobin. An A1C level below 5.7 percent is considered normal. Reported as percentage of glycated hemoglobin.",{"measure":59,"description":60,"timeFrame":42},"Change in C-reactive protein","C-reactive protein will be measured by a blood sample and reported as mg\u002FL",{"measure":62,"description":63,"timeFrame":42},"Change in Lipoprotein","Lipoprotein will be measured by a blood sample and reported as mg\u002FdL",{"measure":65,"description":66,"timeFrame":42},"Change in Macrovascular Function","Peripheral macrovascular function is the maximal percent change in brachial artery following cuff release and will be assessed via flow-mediated dilation and reported as a percentage",{"measure":68,"description":69,"timeFrame":42},"Change in Microvascular Function","Quantification of the area under the curve of the brachial artery blood flow following cuff release",[],"ALL","18 Years","70 Years",{"inclusion":75,"exclusion":76,"raw_text":77},[],[],"Inclusion Criteria: Presence of 3 of the following risk factors:\n\n1. fasting plasma glucose ≥100 mg\u002FdL (or medical therapy for elevated glucose)\n2. HDL-C \\\u003C40 mg\u002FdL in men or \\\u003C50 mg\u002FdL in women (or medical therapy for reduced HDL-C)\n3. Triglycerides ≥150 mg\u002FdL (or medical therapy for elevated triglycerides)\n4. Waist circumference \\>102 cm for men and \\>88 cm for women\n5. Systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥80 mmHg (or medical therapy for hypertension)\n\nExclusion Criteria:\n\n1. Cardiovascular disease diagnosis\n2. Type 1 or 2 diabetes diagnosis\n3. Dairy allergy or lactose intolerance\n4. Self-reported high baseline dairy intake (\\>3 servings per day)\n5. \\>3 hours of physical activity per week\n6. Pregnant women\n7. Inflammatory bowel disease\n8. Chronic steroid use\n9. Allergy to metal\n10. GLP-1 agonist use\n11. Patients on medications related to metabolic syndrome where dose adjustments are planned to be made during the study period.",[79,80],"ADULT","OLDER_ADULT",[82],{"facility":83,"status":8,"city":84,"state":85,"zip":86,"country":87,"contacts":88,"geoPoint":92},"Mayo Clinic in Rochester","Rochester","Minnesota","55905","United States",[89],{"name":90,"role":91},"Joshua R. Smith, PhD","CONTACT",{"lat":93,"lon":94},44.02163,-92.4699,[96],{"name":97,"role":91,"phone":98,"email":99},"Eric Bruhn","507-266-2690","bruhn.eric@mayo.edu",[101],{"name":102,"affiliation":13,"role":103},"Joshua Smith, PhD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":107,"biomarkers":108},[19],[],{"nct_id":4,"found":110,"summary":111,"prompt_version":121},true,{"design":112,"status":113,"heading":114,"summary":115,"follow_up":116,"word_count":117,"commitments":118,"compensation":119,"drugs_mentioned":120},"This interventional study will involve 40 participants. It compares two different diets: a full-fat diet and a low-fat diet.","completed","Study of Milk Consumption in Metabolic Syndrome","This study is looking at how different types of diets, specifically those with full-fat or low-fat foods, affect adults with metabolic syndrome. Metabolic syndrome is a group of risk factors that increase your chance of heart disease, stroke, and diabetes. Researchers want to see how these diets impact your heart health and other metabolic factors. You might be able to join if you are between 18 and 70 years old and have at least three specific risk factors for metabolic syndrome, such as high blood sugar, low \"good\" cholesterol (HDL-C), high triglycerides, or a large waist circumference. The study will measure changes in your total cholesterol, HDL-C, and LDL-C (\"bad\" cholesterol) over about eight weeks to see if the diets make a difference. The study plans to enroll 40 participants, but its current status is unclear.","Your cholesterol levels will be monitored for eight weeks after the start of the study.",136,"You would follow either a full-fat or low-fat diet for three weeks. Your cholesterol levels will be measured at the beginning, after three weeks, after five weeks, and after eight weeks.","Not stated in the trial record.",[],"v2"]