[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cardiometabolic-risk-markers\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cardiometabolic-risk-markers":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":5},"100574380","coffee-bioequivalence-trial-100574380",false,"NCT06758531","Coffee Bioequivalence Trial","Coffee Bioequivalence Trial: Comparing the Pharmacokinetics of Bioactive Components and Physiological Effects of Consuming Encapsulated Instant Coffee Versus Traditional Instant Coffee Brewed in Water","Inclusion Criteria:\n\n* Healthy males and pre-menopausal females (must have regular menstrual cycles)\n* Aged between 18 to 45 years\n* Body mass index (BMI) between 18.5-30 kg\u002Fm2\n\nExclusion Criteria:\n\n* Sensitivity to coffee and caffeine\n* Food allergies relating to the test meals provided (such as gluten or lactose intolerance)\n* Current smoking and vaping use.\n* Medical history of chronic diseases (cancer, high blood pressure (hypertension), type 2 diabetes, heart attack and\u002For any other heart disease related diseases, gastrointestinal disorders, hyperlipidaemia, kidney or liver disease).\n* Diagnosed with anaemia\n* Prescribed any medication relating to the study outcome measures (such as blood pressure lowering, anti-inflammatories or blood thinners).\n* Drinking more than the recommended intake for alcohol (\\> 14 units\u002Fweek)\n* Taking any supplements (vitamins, minerals, probiotics).\n* Any other unusual medical history or diet and lifestyle habits or practices that would preclude volunteers from participating in a dietary intervention and metabolic study (e.g. pacemaker)\n* Planning on a weight-reducing regimen (lost \\>3 kg in the last 6 months)\n* Parallel participation in another intervention study\n* Pregnancy, planning a pregnancy in the next 6 months or breastfeeding\n* NHS blood donation in the last 3 months",true,"ALL","18 Years","45 Years",{"count":21,"type":22},16,"ESTIMATED","INTERVENTIONAL",[25],"NA","The goal of this clinical trial is to test if coffee consumed as a tablet is biologically equivalent to that consumed traditionally as a drink. It will also learn about the impact of the short-term intake of coffee on markers of cardiovascular and liver health. The main questions it aims to answer are:\n\n* Do coffee bioactive compounds produce the same levels in blood and urine regardless of how the coffee is consumed (tablet or drink)?\n* How does coffee as a tablet or drink impact cardiovascular risk and liver health versus a non-coffee control?\n\nParticipants will:\n\n* Visit the clinical unit for three phases; each phase is 1x 480 minute (eight hour) acute postprandial visit and 1 x one hour visit the following day. During each phase they will be randomly assigned to take a different intervention (coffee drink, coffee tablet, coffee-free control)\n* Be cannulated during the 480 minute (8 hour) acute visits and have regular blood draws as well as basic clinical assessments\n* Return on day two for a fasting blood sample and basic clinical assessment\n* Collect their urine for 24 h\n* Be asked to record their intake of foods and drinks for 3 days to assess their usual diet (dietary assessment).",[28,29,30,31],"Liver Functions","Bioequivalence","Cardiovascular Risk","Cardiometabolic Risk Markers",[33,29,34,35,36,37,38,39],"Coffee","Caffeine","Liver function","Polyphenols","Blood pressure","Cardiovascular disease","Chlorogenic acids","NOT_YET_RECRUITING","2025-01-02",{"date":43,"type":44},"2025-01-03","ACTUAL",{"date":46,"type":22},"2025-01",{"date":48,"type":22},"2025-12-30",{"name":50,"class":51},"University of Reading","OTHER"]