[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100574380":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":40,"centralContacts":44,"locations":55,"responsibleParty":84,"collaborators":31,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":31,"eligibilityCriteria":94,"healthyVolunteers":95,"sex":96,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":31,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":111,"overallStatus":119,"whyStopped":31,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"University of Reading","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Coffee given as a drink","ACTIVE_COMPARATOR","This group will consume 3.6 g of commercially available instant coffee given as a drink prepared with 400 ml of water.",[13],"Dietary Supplement: Instant coffee given as a drink",{"label":15,"type":10,"description":16,"interventionNames":17},"Coffee given in tablet form","This group will receive 3.6 g of instant coffee provided as 4 tablets consumed with 400 ml of water.",[18],"Dietary Supplement: Coffee given in a tablet form",{"label":20,"type":21,"description":22,"interventionNames":23},"Control group","PLACEBO_COMPARATOR","The caffeine free coffee control will be provided as 4 tablets given with 400 ml of water.",[24],"Dietary Supplement: Control (placebo)",[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DIETARY_SUPPLEMENT","Instant coffee given as a drink","Commercially available instant coffee (3.6 g) will be provided in the form of a drink prepared with 400 ml of water. A standard breakfast consisting of cereal with milk will be provided at 60 mins after the intervention. A standard lunch (cheese sandwiches, potato crisps and shortbread biscuits) will be given at 300 after coffee intake.",[9],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Coffee given in a tablet form","Commercially available instant coffee (3.6 g) will be provided as 4 tablets given with 400 ml of water. A standard breakfast consisting of cereal with milk will be provided at 60 mins after the intervention. A standard lunch (cheese sandwiches, potato crisps and shortbread biscuits) will be given at 300 after coffee intake.",[15],{"type":27,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"Control (placebo)","A caffeine and coffee free control (3.6 g) will be provided as 4 tablets given with 400 ml of water. A standard breakfast consisting of cereal with milk will be provided at 60 mins after the intervention. A standard lunch (cheese sandwiches, potato crisps and shortbread biscuits) will be given at 300 after coffee intake.",[20],[41],{"name":42,"affiliation":5,"role":43},"Abbe Davy, BSc","STUDY_DIRECTOR",[45,51],{"name":46,"role":47,"phone":48,"phoneExt":49,"email":50},"Charlotte E Mills, PhD","CONTACT","0118378","7108","c.e.mills@reading.ac.uk",{"name":52,"role":47,"phone":48,"phoneExt":53,"email":54},"Kim G Jackson, PhD","5361","k.g.jackson@reading.ac.uk",[56],{"facility":57,"status":31,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Hugh Sinclair Unit of Human Nutrition, Department of Food and Nutritional Sciences, University of Reading","Reading","Berkshire","RG6 6DZ","United Kingdom","UK",{"type":64,"coordinates":65},"Point",[66,67],-0.97113,51.45625,{"lat":67,"lon":66},[70,74,75,76,78,80,82],{"name":71,"role":47,"phone":48,"phoneExt":72,"email":73},"Hugh Sinclair Manager","7771","nutritionvolunteers@reading.ac.uk",{"name":46,"role":47,"phone":31,"phoneExt":31,"email":31},{"name":52,"role":47,"phone":31,"phoneExt":31,"email":31},{"name":77,"role":47,"phone":31,"phoneExt":31,"email":31},"Anisha Wijeyesekera, PhD",{"name":79,"role":47,"phone":31,"phoneExt":31,"email":31},"Altaf Farraj, MSc",{"name":81,"role":47,"phone":31,"phoneExt":31,"email":31},"Lolwa Alawadhi, MSc",{"name":83,"role":47,"phone":31,"phoneExt":31,"email":31},"Tijesu Akeredolu",{"type":85,"investigatorFullName":86,"investigatorTitle":87,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"PRINCIPAL_INVESTIGATOR","Charlotte E Mills","Hugh Sinclair Lecturer in Nutritional Sciences","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":100,"type":101},16,"ESTIMATED","INTERVENTIONAL",[104],"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).",[107,108,109,110],"Liver Functions","Bioequivalence","Cardiovascular Risk","Cardiometabolic Risk Markers",[112,108,113,114,115,116,117,118],"Coffee","Caffeine","Liver function","Polyphenols","Blood pressure","Cardiovascular disease","Chlorogenic acids","NOT_YET_RECRUITING","2025-01-02",{"date":122,"type":123},"2025-01-03","ACTUAL",{"date":125,"type":101},"2025-01",{"date":127,"type":101},"2025-12-30",{"name":5,"class":6},1]