[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06433115":3,"trial-entities:NCT06433115":166,"trial-summary:NCT06433115":170},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":39,"secondary_outcomes":50,"sex":114,"minimum_age":115,"maximum_age":116,"healthy_volunteers":14,"eligibility_criteria":117,"std_ages":140,"locations":142,"central_contacts":160,"overall_officials":162,"references":164,"see_also_links":165},"NCT06433115","2097458","Effects of Lean Beef Consumption on Cardiometabolic Health and Gut Microbiome","RECRUITING","2027-12-01","2025-07","2025-08-01","2024-06-11","University of Missouri-Columbia","OTHER",true,"This study is investigating the benefits of lean beef consumption on cardiometabolic health and gut microbiome.","The study is a 6-wk randomized, controlled, and parallel arm clinical trial. Participants will be randomized to consume either lean grain-fed beef, lean grass-fed beef, or plant-based meat for 6 weeks. Outcomes assessed will include metabolic, inflammatory, and gut microbiome markers.",[18],"Diet Intervention",[],"INTERVENTIONAL","TREATMENT",[23],"NA",{"count":25,"type":26},90,"ESTIMATED",[28,32,35],{"type":13,"name":29,"description":30,"armGroupLabels":31},"Lean (≥90%) Grass-Fed Beef","The specified amount will be 4 oz. per day or 28 ounces per week for participants with an energy requirement of 2000 kcal.",[29],{"type":13,"name":33,"description":30,"armGroupLabels":34},"Lean (≥90%) Grain-Fed Beef",[33],{"type":13,"name":36,"description":37,"armGroupLabels":38},"Plant-Based Meat","Plant-based meat would be macronutrient matched to the same quantities of meat prescribed for a given energy level.",[36],[40,44,47],{"measure":41,"description":42,"timeFrame":43},"LDL-C concentrations","Lipid profile","Baseline, week 6",{"measure":45,"description":46,"timeFrame":43},"Interleukin-6 concentrations","Inflammatory marker",{"measure":48,"description":49,"timeFrame":43},"Gut microbial alpha-diversity","Assessed via16S rRNA sequencing",[51,53,55,57,60,63,66,69,73,75,77,79,82,85,88,91,94,98,101,105,108,111],{"measure":52,"description":42,"timeFrame":43},"HDL-C concentrations",{"measure":54,"description":42,"timeFrame":43},"Total cholesterol concentrations",{"measure":56,"description":42,"timeFrame":43},"Triglyceride concentrations",{"measure":58,"description":59,"timeFrame":43},"Gut microbiome abundance","16S rRNA sequencing",{"measure":61,"description":62,"timeFrame":43},"LPS-binding protein concentration","Intestinal permeability marker",{"measure":64,"description":65,"timeFrame":43},"Glucose concentrations","Blood Glucose",{"measure":67,"description":68,"timeFrame":43},"Insulin concentrations","Insulin",{"measure":70,"description":71,"timeFrame":72},"Body mass","Measured in kg","Baseline, week 3, and week 6",{"measure":74,"description":74,"timeFrame":72},"Fat mass",{"measure":76,"description":76,"timeFrame":72},"Fat-free mass",{"measure":78,"description":78,"timeFrame":72},"Waist circumference",{"measure":80,"description":81,"timeFrame":72},"Hip circumference","Hip Circumference",{"measure":83,"description":84,"timeFrame":72},"Thigh circumference","Thigh Circumference",{"measure":86,"description":87,"timeFrame":43},"24 hour appetite ratings","24-hour appetite ratings assessed on VAS",{"measure":89,"description":90,"timeFrame":43},"Physical activity scores","Activity assessment using Actigraphs",{"measure":92,"description":93,"timeFrame":43},"Total hours of sleep","Sleep diary",{"measure":95,"description":96,"timeFrame":97},"Palatability rating of foods","Hedonic general labelled magnitude scale (gLMS)","Baseline, week 3, week 6",{"measure":99,"description":100,"timeFrame":97},"Acceptance rating of foods","9-point food action rating scale",{"measure":102,"description":103,"timeFrame":104},"Taste and flavor intensity ratings of foods","Sensory intensity scales","Baseline",{"measure":106,"description":107,"timeFrame":43},"Gene expression levels","Transcriptomics analyses",{"measure":109,"description":110,"timeFrame":43},"Inflammatory marker concentrations","Inflammatory markers",{"measure":112,"description":113,"timeFrame":43},"Healthy eating index score","NCI diet history questionnaire","ALL","18 Years","45 Years",{"inclusion":118,"exclusion":126,"raw_text":139},[119,120,121,122,123,124,125],"Age: 18-45 years of age","BMI: 18-35 kg\u002Fm2","Willingness to consume study foods.","Willing to comply with study protocol.","Consistent diet and activity patterns for 4 weeks","Weight stable (≤5 kg change over the last 3 months)","Non-smoker \\>1 year or more",[127,128,129,130,131,132,133,134,135,136,137,138],"Allergies to foods provided in the study","Diabetes","Gastrointestinal disease and\u002For bariatric surgery","Uncontrolled hypertension and blood pressure ≥ 180\u002F110","Illicit drug use","Recent consumption of antibiotics or probiotics","Recent start of medications that affect metabolism or appetite.","Recent blood donation","Drug therapy for coronary artery disease, peripheral artery disease, congestive - heart failure, or dyslipidemia","Pregnant or lactating individuals","Taste or smell disorders","High consumers of red meat or plant-based meat (≥ 4 times\u002Fweek)","Inclusion Criteria:\n\n* Age: 18-45 years of age\n* BMI: 18-35 kg\u002Fm2\n* Willingness to consume study foods.\n* Willing to comply with study protocol.\n* Consistent diet and activity patterns for 4 weeks\n* Weight stable (≤5 kg change over the last 3 months)\n* Non-smoker \\>1 year or more\n\nExclusion Criteria:\n\n* Allergies to foods provided in the study\n* Diabetes\n* Gastrointestinal disease and\u002For bariatric surgery\n* Uncontrolled hypertension and blood pressure ≥ 180\u002F110\n* Illicit drug use\n* Recent consumption of antibiotics or probiotics\n* Recent start of medications that affect metabolism or appetite.\n* Recent blood donation\n* Drug therapy for coronary artery disease, peripheral artery disease, congestive - heart failure, or dyslipidemia\n* Pregnant or lactating individuals\n* Taste or smell disorders\n* High consumers of red meat or plant-based meat (≥ 4 times\u002Fweek)",[141],"ADULT",[143],{"facility":12,"status":7,"city":144,"state":145,"zip":146,"country":147,"contacts":148,"geoPoint":157},"Columbia","Missouri","65211","United States",[149,154],{"name":150,"role":151,"phone":152,"email":153},"Jaapna Dhillon","CONTACT","573-884-2103","jdhillon@missouri.edu",{"name":155,"role":156},"Jaapna Dhillon, PhD","PRINCIPAL_INVESTIGATOR",{"lat":158,"lon":159},38.95171,-92.33407,[161],{"name":150,"role":151,"phone":152,"email":153},[163],{"name":155,"affiliation":12,"role":156},[],[],{"nct_id":4,"conditions":167,"biomarkers":169},[168],"Healthy Volunteers",[],{"nct_id":4,"found":14,"summary":171,"prompt_version":181},{"design":172,"status":173,"heading":174,"summary":175,"follow_up":176,"word_count":177,"commitments":178,"compensation":179,"drugs_mentioned":180},"This is a 6-week randomized, controlled study with three groups of participants. It plans to enroll 90 people.","completed","Lean Beef Consumption and Cardiometabolic Health Study","This study is looking at how eating different types of lean beef or plant-based meat affects your heart health and gut bacteria. Researchers want to see if consuming Lean Grass-Fed Beef, Lean Grain-Fed Beef, or Plant-Based Meat changes things like your LDL-C (a type of cholesterol), Interleukin-6 (a marker of inflammation), and the diversity of bacteria in your gut. You might be able to join if you are between 18 and 45 years old, have a BMI between 18-35, and are willing to eat the study foods. The study is currently unclear on its recruitment status.","Measurements are taken at the beginning and at week 6, which is the end of the intervention period.",96,"You would consume either lean grain-fed beef, lean grass-fed beef, or plant-based meat for 6 weeks. Measurements will be taken at the beginning and at week 6.","Not stated in the trial record.",[36],"v2"]