[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602382":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":32,"locations":38,"responsibleParty":53,"collaborators":57,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":69,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":31,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":85,"overallStatus":90,"whyStopped":31,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"University of Bath","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Energy deficit","EXPERIMENTAL","Diet-induced 50% energy deficit (based on estimated average total daily energy expenditure) by allocation of pre-made meals and snacks over 7-days",[13],"Dietary Supplement: Controlled energy-deficit diet",{"label":15,"type":10,"description":16,"interventionNames":17},"Energy surplus","Diet-induced energy surplus (approximately 500-1000kcal\u002Fday) achieved by allocation of additional snacks to be consumed on top of habitual free-living diet, to avoid inadvertent energy deficit",[18],"Dietary Supplement: Habitual diet with surplus snacks",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DIETARY_SUPPLEMENT","Controlled energy-deficit diet","Participants receive a prepared diet providing approximately 50% of their estimated daily energy expenditure to induce a sustained energy deficit",[9],[9],{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"Habitual diet with surplus snacks","Participants continue their normal diet with the addition of high-calorie snack items to achieve an approximate daily energy surplus",[15],[15],null,[33],{"name":34,"role":35,"phone":36,"phoneExt":31,"email":37},"Joshua J Bakker-Dyos, BSc(Hons) MBChB","CONTACT","+447740191473","jbd28@bath.ac.uk",[39],{"facility":5,"status":31,"city":40,"state":31,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Bath","BA2 7AY","United Kingdom","UK",{"type":45,"coordinates":46},"Point",[47,48],-2.36172,51.3751,{"lat":48,"lon":47},[51],{"name":52,"role":35,"phone":36,"phoneExt":31,"email":37},"Joshua J Bakker-Dyos",{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"PRINCIPAL_INVESTIGATOR","Josh Bakker-Dyos","Principal Investigator",[58],{"name":59,"class":60},"Royal Centre for Defence Medicine","OTHER_GOV","100602382","impact-of-diet-induced-change-in-energy-balance-on-metabolism-in-endurance-athletes-100602382",false,"NCT07122778","Impact of Diet-induced Change in Energy Balance on Metabolism in Endurance Athletes","Impact of Diet-induced Change in Energy Balance on Metabolism in Endurance Athletes: the Carpe DIEM Study","Carpe DIEM","Inclusion Criteria:\n\n* Self-identified endurance-trained sport participants\n* Training volume: \\>7 hours per week endurance training\n* Training frequency: at least 5 days per week\n\nExclusion Criteria:\n\n* Diagnosis of Relative Energy Deficiency in Sport (REDs)\n* Active eating disorder (EDE-Q)\n* Active flare of a chronic disease (e.g. inflammatory bowel disease)\n* Type 1 or 2 diabetes mellitus\n* Untreated or undergoing active treatment of anaemia (any cause)\n* Current injury which precludes undertaking high volume endurance training\n* Individuals following a habitual low-carbohydrate, high-fat diet\n* Any medical diagnosis which precludes intense exercise (e.g. untreated cardiac arrhythmia)\n* Allergy or intolerance to study foods\n* Blood donation within preceding 8 weeks of study start date\n* Use of medications that affect substrate utilisation (e.g. statins, corticosteroids, thyroxine, HRT)\n* For females: current pregnancy, breastfeeding within past 6 months or post-menopausal\n* Unable to undertake a treadmill running test\n* Participation in any research study in the past 8 weeks\n* Participation in a research study within the past year involving more than one DEXA scan\n* Unable to provide informed consent due to impaired cognitive capacity or decision-making ability",true,"ALL","18 Years","49 Years",{"count":74,"type":75},20,"ESTIMATED","INTERVENTIONAL",[78],"NA","Recent research has suggested that increasing levels of physical activity are associated with a reduction in the independent components that contribute to total energy expenditure (such as resting metabolic rate and non-exercise movement) - this occurs to conserve energy required for physical activity where energy provision becomes scarce. There are potential deleterious health and performance consequences of a reduced energy supply to fundamental metabolic processes, putting individuals regularly undertaking high levels of physical activity, such as endurance athletes, at risk. However, this association is largely based on observational data in only moderately active populations, and it is currently unclear what role energy balance status and biological sex has on this relationship.\n\nThis research intends to address these unknowns by assessing the impact of diet-induced manipulation of energy balance (conditions of energy deficit and energy surplus) in individuals undertaking habitually high levels of physical activity on independent components of total energy expenditure (resting metabolism, exercise and non-exercise movement).\n\nMale and female athletes conducting regular moderate-to-high training volumes will undertake a randomised crossover study with a 7-day state of energy deficit and a 7-day state of energy surplus. Participants will continue to live and train as normal, but their diet will be controlled by specific food provision over the intervention periods in order to facilitate both conditions. Independent components of energy expenditure, markers of health, metabolism and performance will be measured to allow for comparison of conditions.",[81,82,83,84],"Energy Balance","Energy Deficit","Low Energy Availability","Relative Energy Deficiency in Sport",[86,87,88,89],"energy deficit","energy balance","energy availability","physical activity","NOT_YET_RECRUITING","2025-08-11",{"date":93,"type":94},"2025-08-14","ACTUAL",{"date":96,"type":75},"2025-08",{"date":98,"type":75},"2027-05",{"name":5,"class":6},1]