[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614916":3},{"organization":4,"outcomesModule":7,"designInfo":47,"detailedDescription":58,"studyPopulation":46,"armGroups":59,"interventions":76,"overallOfficials":86,"centralContacts":91,"locations":100,"responsibleParty":126,"collaborators":128,"id":131,"slug":46,"hasResults":132,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":138,"sex":139,"minAge":140,"maxAge":141,"enrollmentInfo":142,"targetDuration":46,"studyType":145,"phases":146,"briefSummary":148,"conditions":149,"keywords":46,"overallStatus":117,"whyStopped":46,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":160},{"fullName":5,"class":6},"University of Birmingham","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":46},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"Measurement of changes in free-living glycaemic control","Time spent in normal glucose range, under free-living conditions with pre-meal supplementation (measured by continuous glucose monitors)","7 days, two occasions",{"measure":14,"description":15,"timeFrame":16},"Changes in postprandial glucose concentrations in blood","Amplitude of post-meal blood glucose following supplement(s) and controlled meal","4 hours, two occasions",{"measure":18,"description":19,"timeFrame":16},"Concentrations of insulin postprandially in blood","Insulin appearance in blood following supplement(s) and controlled meal",[21,24,27,30,34,38,42],{"measure":22,"description":23,"timeFrame":16},"Concentrations of amino acids postprandially in blood","Total amino acid appearance in blood following supplement(s) and controlled meal",{"measure":25,"description":26,"timeFrame":16},"Concentrations of postprandial appetite hormones","Postprandial appetite hormone concentrations in blood following supplement(s) and controlled meal",{"measure":28,"description":29,"timeFrame":16},"Rate of gastric emptying","Rate of gastric emptying using acetaminophen appearance in the blood following its consumption with supplement(s) and controlled meal.",{"measure":31,"description":32,"timeFrame":33},"Changes in renal function markers after each 7-day phase","Measurement of markers of renal function from urine following each 7-day phase","2 urine samples, 2 occasions",{"measure":35,"description":36,"timeFrame":37},"Assessment of nitrogen balance from urine after each 7-day phase","Nitrogen balance from 24-hour urine collection after each 7-day phase","24 hours, two occasions",{"measure":39,"description":40,"timeFrame":41},"Measurement of blood lipid concentration","Total cholesterol measurement in blood at rest","1 blood draw (obtained from the first blood draw as part of 4 hour visit)",{"measure":43,"description":44,"timeFrame":45},"Optional qualitative assessment of perceptions to supplementation","Optional interview for participants to share perceptions of pre-meal supplementation","60 minutes",null,{"allocation":48,"interventionModel":49,"interventionModelDescription":50,"primaryPurpose":51,"observationalModel":46,"timePerspective":46,"maskingInfo":52},"RANDOMIZED","CROSSOVER","Placebo-controlled partial crossover","BASIC_SCIENCE",{"masking":53,"maskingDescription":46,"whoMasked":54},"TRIPLE",[55,56,57],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR","Within the study, the researchers will look at the effect of supplemental whey protein at moderate and low doses in comparison to each other and a protein-free placebo on glycaemic control in older adults aged between 75-90 years of age, living with type 2 diabetes.\n\nGlycaemic control (glucose excursions) will be monitored under free-living conditions over a 7-day period using continuous glucose monitors (CGMs). Participants will be randomised to consume one of the two whey protein doses as well as the protein-free placebo on a separate 7-day period. The order of consuming whey protein or the protein-free placebo will be randomised and counterbalanced. This study is under the evidence that in younger people living with type 2 diabetes, a moderate dose of whey protein improves glucose time in range and lessens extreme postprandial glucose excursions.\n\nParticipants will be free to consume their typical diet over this period, where the researchers will provide a diet diary for participants to enter in all foods and drinks they consume over this time period, as well as document the ingestion of the supplement before each main meal.\n\nDuring an acute feeding period on the first ingestion of each supplement (start of each 7-day phase), the researchers will evaluate rates of gastric emptying, glucose and insulin concentrations and hormonal appetite markers through blood draws, as well as perceived appetite responses through visual analogue scales. This will be in a research kitchen where participants will consume the supplement and a controlled mixed meal afterwards to monitor excursions in appetite response and glycemia. The researchers will also investigate the impact of pre-meal protein feeding on renal markers following each 7-day phase via urine collection.",[60,67,71],{"label":61,"type":62,"description":63,"interventionNames":64},"pre-meal low dose whey protein","ACTIVE_COMPARATOR","Low whey protein dose administration before meals",[65,66],"Dietary Supplement: Glycaemic control with whey protein","Dietary Supplement: Glycaemic control with different doses of whey protein",{"label":68,"type":62,"description":69,"interventionNames":70},"pre-meal moderate dose whey protein","Moderate whey protein dose administration before meals",[65,66],{"label":72,"type":73,"description":74,"interventionNames":75},"pre-meal protein-free placebo","PLACEBO_COMPARATOR","protein-free placebo administration before meals",[65],[77,82],{"type":78,"name":79,"description":80,"armGroupLabels":81,"otherNames":46},"DIETARY_SUPPLEMENT","Glycaemic control with whey protein","Comparing pre-meal supplementation of whey protein to protein-free placebo.",[61,68,72],{"type":78,"name":83,"description":84,"armGroupLabels":85,"otherNames":46},"Glycaemic control with different doses of whey protein","Comparing pre-meal supplementation of moderate whey protein to a low dose of whey protein.",[61,68],[87],{"name":88,"affiliation":89,"role":90},"Leigh Breen, PhD","University of Birmingham and University of Leciester","PRINCIPAL_INVESTIGATOR",[92,97],{"name":88,"role":93,"phone":94,"phoneExt":95,"email":96},"CONTACT","(0)1214144109","+44","l.breen@bham.ac.uk",{"name":98,"role":93,"phone":46,"phoneExt":46,"email":99},"Marie Korzepa, PhD","m.korzepa@bham.ac.uk",[101,115],{"facility":102,"status":103,"city":104,"state":105,"zip":106,"country":107,"countryCode":108,"cosmosGeoPoint":109,"geoPoint":114,"contacts":46},"School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham","ENROLLING_BY_INVITATION","Birmingham","West Midlands","B15 2TT","United Kingdom","UK",{"type":110,"coordinates":111},"Point",[112,113],-1.89983,52.48142,{"lat":113,"lon":112},{"facility":116,"status":117,"city":104,"state":46,"zip":46,"country":107,"countryCode":108,"cosmosGeoPoint":118,"geoPoint":120,"contacts":121},"Heartlands Hospital","RECRUITING",{"type":110,"coordinates":119},[112,113],{"lat":113,"lon":112},[122],{"name":123,"role":93,"phone":124,"phoneExt":125,"email":46},"Srikanth Bellary, MD","4240234","0121",{"type":127,"investigatorFullName":46,"investigatorTitle":46,"investigatorAffiliation":46,"oldNameTitle":46,"oldOrganization":46},"SPONSOR",[129],{"name":130,"class":6},"Newcastle University","100614916",false,"NCT07285811","GLycaemic Outcomes With Whey Protein in ageING","Whey Protein Dose-response Effect on Daily Glycaemic Excursions in Very Old Individuals With Type 2 Diabetes","GLOWING","* Male or female\n* 75-90 years old\n* Type 2 Diabetes (confirmed with glycated haemoglobin (HbA1c) \\>6.5% in clinic or in SportExR)\n* Stable body mass (body mass index (BMI) ≤40kg\u002Fm2)\n* Generally healthy, assessed via a General Health Questionnaire (GHQ)\n* Some residual beta-cell activity (confirmed with urine test on induction)\n* Normal or moderately increased albuminuria (needs to be below 300mg\u002Fg)\n* Normal, mildly or moderately decreased glomerular filtration rate (GFR) (needs to be above 45ml\u002Fmin\u002F1.732).\n* Able and willing to attend SportExR a total of 5 times: 1 induction and 2 testing visits and 2 return check-up visits.\n\nExclusion Criteria:\n\n* \\\u003C75 years old and over 90 years of age\n* Currently on fast-acting insulin therapy (i.e., Humalog)\n* Confirmed uncontrolled diabetes (HbA1C \\>10% or 85mmol\u002Fmol).\n* Currently on GLP-1 therapy\n* Habitual smoker or vaper\n* Veganism\n* Lactose or dairy intolerance\n* Coeliac or gluten intolerance\n* History of gastrointestinal disease\n* Experienced a hyperglycaemic or hypoglycaemic event requiring treatment in the past 12 months\n* Recent Ischemic stroke (\\\u003C3 months).\n* Use of anticoagulants (e.g. warfarin, rivaroxaban)\n* Considered unwilling or unable to comply with the study protocol requirements by the research team",true,"ALL","75 Years","90 Years",{"count":143,"type":144},32,"ESTIMATED","INTERVENTIONAL",[147],"NA","The goal of this placebo-controlled, partial crossover design study is to identify the impact of consuming whey protein before meals on free-living glucose control in older adults living with type 2 diabetes.\n\nThe primary specific objective is to determine the effect of a thrice daily whey protein pre-meal supplementation at two doses, on glucose excursions over a 7-day free-living period in adults aged 75-90 years of age, living with type 2 diabetes, compared with a non-protein placebo.\n\nParticipants will consume the whey protein and placebo for 7 days each, before each meal. All participants will consume the placebo and one of two doses of whey protein, in a randomised order.",[150],"Type 2 Diabetes","2025-12-02",{"date":153,"type":154},"2025-12-16","ACTUAL",{"date":156,"type":144},"2025-12",{"date":158,"type":144},"2026-12",{"name":5,"class":6},2]