[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568715":3},{"organization":4,"outcomesModule":7,"designInfo":80,"detailedDescription":85,"studyPopulation":85,"armGroups":88,"interventions":102,"overallOfficials":85,"centralContacts":111,"locations":117,"responsibleParty":133,"collaborators":85,"id":136,"slug":85,"hasResults":137,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":85,"eligibilityCriteria":141,"healthyVolunteers":142,"sex":143,"minAge":144,"maxAge":145,"enrollmentInfo":146,"targetDuration":85,"studyType":149,"phases":150,"briefSummary":152,"conditions":153,"keywords":155,"overallStatus":119,"whyStopped":85,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":171},{"fullName":5,"class":6},"University of Bath","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":47},[9],{"measure":10,"description":11,"timeFrame":12},"Post Prandial Triglyceride Area Under the Curve (AUC)","Plasma triglyceride concentrations assessed postprandially for 5 hours after a mixed meal test","Pre and post intervention (4 weeks)",[14,17,19,22,25,28,31,34,36,38,41,44],{"measure":15,"description":16,"timeFrame":12},"Fat Mass","Measured in kilogrammes using Dual Energy X-ray Absorptiometry",{"measure":18,"description":16,"timeFrame":12},"Lean Body Mass",{"measure":20,"description":21,"timeFrame":12},"Fasting and Post Prandial Glucose Concentration","Plasma glucose concentrations assessed after an overnight fast, postprandially for 5 hours after a mixed meal test",{"measure":23,"description":24,"timeFrame":12},"Fasting and Post Prandial Insulin Concentration","Plasma insulin concentrations assessed after an overnight fast, postprandially for 5 hours after a mixed meal test",{"measure":26,"description":27,"timeFrame":12},"Fasting and Post Prandial NEFA Concentration","Plasma NEFA concentrations assessed after an overnight fast, postprandially for 5 hours after a mixed meal test",{"measure":29,"description":30,"timeFrame":12},"Fasting Triglyceride Concentration","Plasma triglyceride concentrations assessed after an overnight fast",{"measure":32,"description":33,"timeFrame":12},"Fasting Total Cholesterol Concentration","Assessed after an overnight fast",{"measure":35,"description":33,"timeFrame":12},"Fasting LDL-C Concentration",{"measure":37,"description":33,"timeFrame":12},"Fasting HDL-C Concentration",{"measure":39,"description":40,"timeFrame":12},"Substrate Oxidation","Carbohydrate and fat oxidation rates will be measured using indirect calorimetry at rest and every hour postprandially",{"measure":42,"description":43,"timeFrame":12},"Adipose Tissue Gene Expression","Expression of several genes related to energy metabolism in adipose biopsies using real-time polymerase chain reaction (RT-PCR)",{"measure":45,"description":46,"timeFrame":12},"Adipose Tissue Protein Expression","Expression of several proteins related to energy metabolism in adipose biopsies using Western blot",[48,52,55,59,63,67,70,74,77],{"measure":49,"description":50,"timeFrame":51},"Physical Activity Energy Expenditure (kJ or kcal)","Assessed using combined heart rate and accelerometery wearable monitor (Actiheart™) in free-living conditions.","1 week during baseline monitoring, and weeks 1 and 4 of the intervention",{"measure":53,"description":54,"timeFrame":51},"Time Spent in Different Physical Activity Intensities (minutes)","Assessed using combined heart rate and accelerometery wearable monitor (Actiheart™) in free-living conditions",{"measure":56,"description":57,"timeFrame":58},"Dietary Intake","Dietary records manually kept by study participants","1 week during baseline monitoring, and weeks 1 and 4 of intervention",{"measure":60,"description":61,"timeFrame":62},"Interstitial Glucose","Continuous glucose records will be used to capture interstitial glucose before and during the intervention","2 weeks during baseline monitoring, 2 weeks during weeks 3-4 of intervention",{"measure":64,"description":65,"timeFrame":66},"Sleep Quality","Self-reported sleep quality will be assessed via the Pittsburgh Sleep Quality Index (PSQI) questionnaire, consisting of 9 questions. Seven component scores are derived, scored from 0 (no difficulty) to 3 (severe difficulty)","Pre and post intervention (10 weeks)",{"measure":68,"description":69,"timeFrame":66},"Diet Satisfaction","Diet satisfaction will be assessed via the 28-item Diet Satisfaction Questionnaire (28-DSQ), scored on a five-point Likert scale with 1 being 'Disagree Strongly' and 5 being 'Agree Strongly'",{"measure":71,"description":72,"timeFrame":73},"Engagement with Mobile Application","Data on number of sessions, session length, session interval and session frequency will be obtained through the Salus Metabolism mobile health application","4 weeks post intervention",{"measure":75,"description":76,"timeFrame":73},"Usability of Mobile Application","Assessed via the mHealth App Usability Questionnaire, consisting of 16 statements scored on a seven-point Likert scale with 1 being 'Disagree' and 7 being 'Agree'",{"measure":78,"description":79,"timeFrame":73},"Subjective App Usability and Engagement","Participants will be asked to provide feedback on the Salus Metabolism mHealth application through a semi-structured interview. Thematic analysis will be used to analyse interview data.",{"allocation":81,"interventionModel":82,"interventionModelDescription":83,"primaryPurpose":84,"observationalModel":85,"timePerspective":85,"maskingInfo":86},"RANDOMIZED","PARALLEL","A randomised, three-arm parallel-group study","BASIC_SCIENCE",null,{"masking":87,"maskingDescription":85,"whoMasked":85},"NONE",[89,95,99],{"label":90,"type":91,"description":92,"interventionNames":93},"5:2 carbohydrate restriction (5:2CR)","EXPERIMENTAL","Laboratory measurements will be obtained before and after the intervention. Physical activity, dietary intake and interstitial glucose concentrations will be monitored in free-living conditions throughout the intervention.",[94],"Other: 5:2 carbohydrate restriction",{"label":96,"type":91,"description":92,"interventionNames":97},"Early time-restricted carbohydrate intake (eTRC)",[98],"Other: Early time-restricted carbohydrate intake",{"label":100,"type":101,"description":92,"interventionNames":85},"Lifestyle maintenance (control)","NO_INTERVENTION",[103,107],{"type":6,"name":104,"description":105,"armGroupLabels":106,"otherNames":85},"5:2 carbohydrate restriction","Carbohydrate ingestion restricted to \\\u003C8% of energy intake on 2 self-selected consecutive days each week over 28-30 days. Ad libitum dietary amount, type and pattern followed on the remaining 5 days each week.",[90],{"type":6,"name":108,"description":109,"armGroupLabels":110,"otherNames":85},"Early time-restricted carbohydrate intake","Carbohydrate intake restricted to \\\u003C8% of energy intake after 4pm each day for 28 days. Ad libitum dietary amount, type and pattern followed before 4pm.",[96],[112],{"name":113,"role":114,"phone":115,"phoneExt":85,"email":116},"Guoda Karoblyte","CONTACT","+44 (0) 1225 386478","gk678@bath.ac.uk",[118],{"facility":5,"status":119,"city":120,"state":121,"zip":122,"country":123,"countryCode":124,"cosmosGeoPoint":125,"geoPoint":130,"contacts":131},"RECRUITING","Bath","Somerset","BA2 7AY","United Kingdom","UK",{"type":126,"coordinates":127},"Point",[128,129],-2.36172,51.3751,{"lat":129,"lon":128},[132],{"name":113,"role":114,"phone":115,"phoneExt":85,"email":116},{"type":134,"investigatorFullName":113,"investigatorTitle":135,"investigatorAffiliation":5,"oldNameTitle":85,"oldOrganization":85},"PRINCIPAL_INVESTIGATOR","Principal Investigator","100568715",false,"NCT06684834","Intermittent Carbohydrate Restriction in Cardiometabolic Health","The Effects of Intermittent Carbohydrate Restriction on Metabolic Health and Energy Balance in Adults with Abdominal Overweight and Obesity","Inclusion Criteria:\n\n1. Waist circumference of ≥94 cm (37 inches) if male and ≥80 cm (31.5 inches) if female, or BMI above 25 kg\u002Fm2\n2. Fat mass index (FMI) of \\>6 kg\u002Fm2 for males, and \\>9 kg\u002Fm2 for females\n3. Aged between 18-65 years\n4. Has maintained a stable weight in the last three months (\\\u003C3% change in body mass)\n5. Keeps track of menstrual cycle regularity or oral contraceptive use (females only)\n\nExclusion Criteria:\n\n1. Has a body weight of ≥120kg\n2. Plans to undertake other lifestyle modifications during the study to manage weight (e.g. changes in dietary intake or activity levels)\n3. Current or previous eating disorder\n4. Diagnosed with major chronic conditions (e.g. type 2 diabetes, coronary heart disease, cancer, chronic kidney disease, etc.)\n5. Use of medication that may interfere with study outcomes (e.g. glucose or lipid lowering medications)\n6. Currently or recently pregnant (within last 6 months), planning to get pregnant or currently lactating\n7. Has donated more than 500ml of blood in the last 3 months prior to the initial laboratory visit\n8. Insufficient mental capacity or language skills to independently understand and follow the study protocol\n9. Dietary restrictions to ingredients in test meals (e.g. gluten and lactose)\n10. Has an irregular sleeping pattern (e.g. due to undertaking night-shift work)\n11. Any condition, concurrent intervention or behaviour deemed either to pose undue personal risk to the participant or to introduce bias into the experiment",true,"ALL","18 Years","65 Years",{"count":147,"type":148},36,"ESTIMATED","INTERVENTIONAL",[151],"NA","Metabolic conditions, such as heart disease, type 2 diabetes, and metabolic syndrome, are among the leading causes of disability and mortality worldwide. Identifying innovative lifestyle strategies to reduce metabolic risk remains a public health priority. Further research is essential to understand how low carbohydrate intake influences human metabolism and how intermittent carbohydrate restriction impacts weight loss and metabolic health markers.\n\nThis study will investigate two interventions that restrict dietary carbohydrate intake on different schedules, examining their effects on metabolic health and energy balance in adults with abdominal overweight or obesity. The physiological mechanisms potentially underlying these effects will be explored by measuring a range of lifestyle and metabolic health parameters in both free-living and laboratory settings. A digital behaviour-change intervention will be incorporated after the dietary intervention to assess whether any metabolic effects can be sustained over time.\n\nThe study employs a three-arm parallel-group design consisting of a two-week lifestyle monitoring phase, a four-week dietary intervention, and a four-week digital intervention, with four laboratory visits throughout each phase. During the dietary intervention, participants will be allocated to one of three groups: (i) carbohydrate restriction (\\\u003C8% of energy intake) on two consecutive days per week, (ii) carbohydrate restriction after 4 pm each day, or (iii) no dietary changes.\n\nDietary intake, physical activity, and glucose levels will be monitored through wearable devices in free-living conditions. The digital intervention will use a mobile health application that provides individualised lifestyle recommendations and education based on data collected in free-living conditions. Laboratory-based measures will include anthropometry, body composition scans, indirect calorimetry, blood pressure monitoring, fat biopsies, and postprandial sampling of blood and expired air.",[154],"Obesity and Overweight",[156,157,158,159,160,161],"carbohydrate restriction","carbohydrate timing","intermittent carbohydrate restriction","intermittent energy restriction","evening carbohydrate restriction","carbohydrate periodisation","2024-11-09",{"date":164,"type":165},"2024-11-12","ACTUAL",{"date":167,"type":165},"2023-09-05",{"date":169,"type":148},"2036-10",{"name":5,"class":6},1]