[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621380":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":38,"centralContacts":42,"locations":48,"responsibleParty":60,"collaborators":30,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":30,"eligibilityCriteria":68,"healthyVolunteers":69,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":30,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":86,"overallStatus":91,"whyStopped":30,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Northumbria University","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1","EXPERIMENTAL","Participants will be randomly allocated to consume investigational supplement (1 of 2 proprietary 'active' compositions) for 28 days.",[13],"Dietary Supplement: Proprietary 'active' composition 1",{"label":15,"type":10,"description":11,"interventionNames":16},"Arm 2",[17],"Dietary Supplement: Proprietary 'active' composition 2",{"label":19,"type":20,"description":21,"interventionNames":22},"Control","PLACEBO_COMPARATOR","Participants will be randomly allocated to consume control supplement for 28 days.",[23],"Dietary Supplement: Inactive control supplement",[25,31,34],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DIETARY_SUPPLEMENT","Proprietary 'active' composition 1","A proprietary orally administered dietary supplement consisting of standardized ingredients.",[9],null,{"type":26,"name":32,"description":28,"armGroupLabels":33,"otherNames":30},"Proprietary 'active' composition 2",[15],{"type":26,"name":35,"description":36,"armGroupLabels":37,"otherNames":30},"Inactive control supplement","Flavored vehicle",[19],[39],{"name":40,"affiliation":5,"role":41},"Professor Jason Ellis, PhD","PRINCIPAL_INVESTIGATOR",[43],{"name":44,"role":45,"phone":46,"phoneExt":30,"email":47},"Pamela Alfonso-Miller, MD","CONTACT","+44 01912274149","pam.alfonso-miller@northumbria.ac.uk",[49],{"facility":50,"status":30,"city":51,"state":30,"zip":30,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":30},"Northumbria University- Northumbria Sleep center and NUTRAN","Newcastle upon Tyne","United Kingdom","UK",{"type":55,"coordinates":56},"Point",[57,58],-1.61396,54.97328,{"lat":58,"lon":57},{"type":61,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100621380","evaluating-the-effects-of-nutritional-interventions-on-sleep-the-gut-microbiome-cognition-and-stress-100621380",false,"NCT07369869","Evaluating the Effects of Nutritional Interventions on Sleep, the Gut Microbiome, Cognition, and Stress.","Evaluating the Effects of Nutritional Interventions on Sleep, the Gut Microbiome, Cognition, and Stress Following 28 Days Consumption in Adults Reporting Sub-clinical Sleep Deficits: A Randomised, Double-blind, Placebo-controlled, Three-arm Parallel Groups Trial.","INCLUSION CRITERIA\n\n* Participants must self-assess themselves as being in good health.\n* Aged 25 to 60 years at the time of randomisation\n* Fluent in English\n* Identify as a 'poor sleeper' as defined subjectively (i.e. poor sleep quality, unrefreshing sleep) and a total score of \\>5 on the Pittsburgh Sleep Quality Index (PSQI).\n\nEXCLUSION CRITERIA\n\n* Member of own household currently participating in this trial\n* Evidence of current or recent sleep disorders (e.g. sleep apnoea, insomnia, circadian rhythm disorders), taking any medication which exerts sedative effects, affects the CNS and\u002For sleep, or be currently unwell with any illness that affects sleep (i.e. disorders of the CNS). An initial screening for sleep disorders will be conducted using the Sleep Disorders Symptom Checklist-25 (SDS-CL; Klingman et al., 2017). If a participant reports positively to any of the 25 questions in terms of being affected for three nights per week, or more, this will be followed up using a clinical interview according to the International Classification of Sleep Disorders (ICSD-3) to exclude on the basis of a sleep disorder\n* History of seizures or epilepsy\n* Shift working or have a history of shift work within the previous six months\n* Currently, or within the previous 8 weeks, consuming any nutritional supplements.\n* Participation in any other intervention research trials\n* Sleeping at a location other than their usual residence more than two nights per week during participation\n* Travel across multiple time zones within the last three months or have planned travel across multiple time zones during the study\n* Current or recent mood disturbances or Axis I disorders (descriptions will be given)\n* Current misuse of alcohol and\u002For drugs\n* Current smoker\n* Recent (within the last 12 weeks) infection and\u002For use of antibiotic medication\n* Pregnant, seeking to become pregnant or lactating\n* Those using (including within the last 2 weeks) proton-pump inhibitors",true,"ALL","25 Years","65 Years",{"count":74,"type":75},68,"ESTIMATED","INTERVENTIONAL",[78],"NA","This will be a double-blind, placebo-controlled, parallel-group trial. Participants who are poor sleepers will be randomised to receive one of two investigational supplements, or a placebo control supplement, over a 28-day period. At baseline and following 28 days of consumption, sleep quality, gut microbiome profiles, cognitive performance, and mood will be assessed. Sleep outcome measures will also be assessed throughout the supplementation period to monitor the time course of any observed changes. A final data set of at least 66 participants is expected.",[81,82,83,84,85],"Stress","Sleep","Cognition","Nutrition","Microbiome",[87,88,89,90],"sleep","gut health","cognition","stress","NOT_YET_RECRUITING","2026-02-27",{"date":94,"type":95},"2026-03-03","ACTUAL",{"date":97,"type":75},"2026-05",{"date":99,"type":75},"2026-12",{"name":5,"class":6},1]