[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100511948":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":35,"centralContacts":40,"locations":48,"responsibleParty":79,"collaborators":82,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":24,"eligibilityCriteria":91,"healthyVolunteers":92,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":24,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":51,"whyStopped":24,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"University of Minho","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Binge Drinkers with Inulin Intervention","ACTIVE_COMPARATOR","23 binge drinkers (\\~50 % male and \\~50 % female) will be given a daily dose of inulin.",[13],"Dietary Supplement: Inulin Intervention",{"label":15,"type":16,"description":17,"interventionNames":18},"Binge Drinkers with Maltodextrin Intervention","PLACEBO_COMPARATOR","23 binge drinkers (\\~50 % male and \\~50 % female) will be given a daily dose of maltodextrin.",[19],"Dietary Supplement: Maltodextrin Intervention",{"label":21,"type":22,"description":23,"interventionNames":24},"Non\u002FLow-Drinkers","NO_INTERVENTION","36 non\u002Flow-drinkers will not be given any dietary fiber.",null,[26,31],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":24},"DIETARY_SUPPLEMENT","Inulin Intervention","For 6 weeks, 23 binge drinkers will be given a daily dose (divided into three times a day) of 15g of a dietary fiber with benefits for intestinal bacteria (inulin).",[9],{"type":27,"name":32,"description":33,"armGroupLabels":34,"otherNames":24},"Maltodextrin Intervention","For 6 weeks, 23 binge drinkers will be given a daily dose (divided into three times a day) of 15g of dietary fiber with no specific benefits for the intestinal microbiome (maltodextrin).",[15],[36],{"name":37,"affiliation":38,"role":39},"Eduardo G. López-Caneda, PhD","Psychological Neuroscience Laboratory, Psychology Research Center, University of Minho, Portugal.","PRINCIPAL_INVESTIGATOR",[41,45],{"name":37,"role":42,"phone":43,"phoneExt":24,"email":44},"CONTACT","(+351) 253 604 223","eduardo.lopez@psi.uminho.pt",{"name":46,"role":42,"phone":24,"phoneExt":24,"email":47},"Clarisse N. Gonçalves, PhD","clarissenobre@deb.uminho.pt",[49],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Psychological Neuroscience Laboratory, Psychology Research Center, University of Minho","RECRUITING","Braga","Gualtar, Braga","4710-057","Portugal","PT",{"type":58,"coordinates":59},"Point",[60,61],-8.42311,41.5514,{"lat":61,"lon":60},[64,65,66,69,71,73,75,77],{"name":37,"role":42,"phone":43,"phoneExt":24,"email":44},{"name":46,"role":42,"phone":24,"phoneExt":24,"email":47},{"name":67,"role":68,"phone":24,"phoneExt":24,"email":24},"Sónia S. Sousa, PhD","SUB_INVESTIGATOR",{"name":70,"role":68,"phone":24,"phoneExt":24,"email":24},"Carina Carbia, PhD",{"name":72,"role":68,"phone":24,"phoneExt":24,"email":24},"Natália A. Almeida-Antunes, PhD Student",{"name":74,"role":68,"phone":24,"phoneExt":24,"email":24},"Rui S. Rodrigues, PhD Student",{"name":76,"role":68,"phone":24,"phoneExt":24,"email":24},"Pedro S. Azevedo, PhD Student",{"name":78,"role":68,"phone":24,"phoneExt":24,"email":24},"Diogo P. Martins, MS",{"type":39,"investigatorFullName":80,"investigatorTitle":81,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Eduardo López-Caneda","Assistant Reseacher",[83],{"name":84,"class":6},"Foundation for Science and Technology, Portugal","100511948","phase-2-the-brain-the-bug-and-the-binge-the-interplay-between-binge-drinking-gut-microbiota-and-brain-functioning-100511948",false,"NCT05946083","The Brain, the Bug, and the Binge: the Interplay Between Binge Drinking, Gut Microbiota, and Brain Functioning","The Brain, the Bug, and the Binge: a Double-blind, Randomized Controlled Trial Investigating the Interplay Between Binge Drinking, Gut Microbiota and Brain Functioning","Inclusion Criteria:\n\n* College students whose native language is Portuguese;\n* Age 18-23 years;\n* Binge Drinkers: report (i) drinking 4 (for women)\u002F5 (for men) or more drinks on one occasion at least once a month, (ii) drinking at a speed of at least two drinks per hour during these episodes (which brings blood alcohol concentration to 0.08 g\u002FdL or above), and (iii) having an AUDIT score \\\u003C 20.\n* Non\u002FLow-Drinkers: report (i) never drinking 4\u002F5 or more drinks on one occasion and (ii) having an AUDIT score ≤ 4.\n\nExclusion Criteria:\n\n* Use of illicit drugs as determined by the Drug Use Disorders Identification Test (DUDIT);\n* Alcohol abuse (i.e., AUDIT ≥ 20);\n* Personal history of psychopathological disorders (according to DSM-V criteria);\n* History of traumatic brain injury or neurological disorder;\n* Family history (mother\u002Ffather) of alcoholism diagnosis of substance abuse;\n* Occurrence of one or more episodes of loss of consciousness for more than 30 minutes;\n* Non-corrected sensory deficits;\n* Diagnosis of any gut disease\u002Fproblems or other medical conditions: inflammatory bowel disease, irritable bowel syndrome, Crohn's Disease, celiac disease, lactose intolerance, autoimmune disease;\n* Consumption of medical drugs with psychoactive effects (e.g., antidepressants, anxiolytics or benzodiazepines) during the 4 weeks prior to the experiment;\n* Use of any of the following drugs in the last 4 weeks: laxatives, antibiotics, anticoagulants, non-steroidal anti-inflammatory drugs, analgesics, corticosteroids;\n* No type of metal object implanted in the body, especially in the head (orthodontic appliances are not excluded).",true,"ALL","18 Years","23 Years",{"count":97,"type":98},82,"ESTIMATED","INTERVENTIONAL",[101],"PHASE2","Adolescence and youth are periods of significant maturational changes which seems to involve greater susceptibility to disruptive events in the brain such as binge drinking (BD). This prevalent pattern of consumption -characterized by repeated alcohol intoxications- is of special concern, as it has been associated with major neurocognitive impairments in the young brain.\n\nRecent studies indicate that alcohol may disrupt the gut microbiota (GM) and that these disruptions may lead to impairments in brain and behavior. Also, interventions with psychobiotics have been shown to result in reductions in alcohol-induced damage and in improvements on cognitive and brain functioning.\n\nThus, the present proposal will explore the effects of BD on GM. Additionally, a GM intervention with psychobiotics both in-vivo and in-vitro, will determine whether improvements in GM composition\u002Ffunction may lead to reductions of alcohol-induced brain damage in BD-population, a barely unexplored research field with major clinical applications.",[104],"Binge Drinking",[106,107,108,104,109,110,111,112,113,114],"Adolescence","Young Adulthood","Alcohol","Gut Microbiome","Microbiota-Gut-Brain Axis","Magnetic Resonance Imaging","Pro-inflammatory cytokines","Psychobiotics","Randomized Controlled Trial","2025-07-10",{"date":117,"type":118},"2025-07-16","ACTUAL",{"date":120,"type":118},"2023-02-24",{"date":122,"type":98},"2025-11-30",{"name":5,"class":6},1]