[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100579381":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":43,"locations":53,"responsibleParty":71,"collaborators":74,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":88,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":47,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":102,"overallStatus":107,"whyStopped":47,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Universidade do Porto","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Psychobiotic group","EXPERIMENTAL","An intervention group receiving a psychobiotic-a native inulin prebiotic. Native inulin extracted from chicory roots was selected as the psychobiotic since it is a mixture of short inulin molecules, which are metabolized primarily in the proximal colon and are more rapidly fermented, with longer chain ones, which are fermented later and slower in the distal colon. The psychobiotic nature of Inulin has been suggested in recent literature.",[13],"Dietary Supplement: Psychobiotic treatment",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","PLACEBO_COMPARATOR","A control group receiving a taste\u002Fappearance-matched placebo- the maltodextrin. Maltodextrin is a carbohydrate consisting of short chains of glucose molecules. It is commonly used as a placebo in clinical trials, providing no significant health benefits or harm when consumed with moderation.",[19],"Other: Placebo treatment",[21,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Psychobiotic treatment","The dietary supplementation will follow established guidelines, recommending an intake of 16 g of prebiotic per day, distributed across three meals, for a duration of 12 weeks.",[9],[27,28],"Prebiotic","Inulin",{"type":6,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Placebo treatment","The control group will receive identical packaging that matches the experimental treatment in taste and appearance and will follow the same guidelines for consuming the placebo. For ethical reasons, after the end of the RCT, the control group will be given the option to receive the same prebiotic supplement.",[15],[34],"Maltodextrin (Placebo)",[36,40],{"name":37,"affiliation":38,"role":39},"Eva M. Conceição","Center for Psychology at University of Porto (CPUP)","PRINCIPAL_INVESTIGATOR",{"name":41,"affiliation":42,"role":39},"Clarisse N. Salomé","Center for Engineering Biological (CEB) at University of Minho",[44,49],{"name":37,"role":45,"phone":46,"phoneExt":47,"email":48},"CONTACT","+351 917 853 236",null,"econceicao@fpce.up.pt",{"name":50,"role":45,"phone":51,"phoneExt":47,"email":52},"Catarina C. Gomes","914841706","202408503@fpce.up.pt",[54],{"facility":55,"status":47,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Center for Psychology at University of Porto","Porto","Paranhos","4200-135","Portugal","PT",{"type":62,"coordinates":63},"Point",[64,65],-8.61097,41.1485,{"lat":65,"lon":64},[68],{"name":55,"role":45,"phone":69,"phoneExt":47,"email":70},"+351 220 400 617","cpup@fpce.up.pt",{"type":39,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":47,"oldOrganization":47},"Eva Conceição","Research Fellow",[75,77],{"name":76,"class":6},"University of Minho",{"name":78,"class":79},"Braga Hospital","UNKNOWN","100579381","phase-1-investigation-of-the-mechanisms-of-the-gut-brain-axis-in-binge-eating-and-obesity-100579381",false,"NCT06823557","Investigation of the Mechanisms of the Gut-brain Axis in Binge Eating and Obesity.","Gut2Brain: Investigation of the Mechanisms of the Gut-brain Axis in Binge Eating and Obesity","Gut2Brain","Inclusion Criteria:\n\n* Portuguese adults (25 with normal weight; 25 with obesity only (30 ≤ BMI \\\u003C 40) and BED; 54 with BED)\n* Residents in Portugal for the past 10 years\n\nExclusion Criteria:\n\n* Significant weight loss (\\>5% of body weight) in the past 2 years\n* Antibiotic use in the past 6 months\n* History of surgery or medical\u002Fpsychiatric diseases\n* Pregnant or breastfeeding\n* History of drug use or dependence\n* Use of medications that impact weight\n* Have metal implants or pacemakers",true,"ALL","20 Years","45 Years",{"count":93,"type":94},104,"ESTIMATED","INTERVENTIONAL",[97],"PHASE1","Binge Eating Disorder (BED) is a recently recognized eating disorder, characterized by recurrent episodes of overeating with a loss of control. Highly comorbid with obesity, BED is associated with poor outcomes in weight loss treatments and presents unique challenges due to its distinct neuro-psycho-biological mechanisms, which remain poorly understood. The Microbiota-Gut-Brain Axis (MGBA) is a bidirectional communication system linking the gut microbiota with the central nervous system, that plays a critical role in regulating appetite, mood, and eating behavior. Dysregulations in MGBA may contribute to the development and maintenance of BED, offering a novel framework for understanding its complex mechanisms and identifying new therapeutic targets. Psychobiotics -pre-, pro-, or symbiotics that modulate the microbiota- emerge as a promising treatment strategy to address BED symptoms by influencing MGBA activity.\n\nThe goal of this randomized clinical trial (RCT) is to investigate the role of psychobiotics in modulating the gut-brain axis and improving binge eating in adults, with a particular focus on evaluating these effects independently of obesity status. This project stands out for its comprehensive approach to understanding BED, integrating psychological, neurofunctional, hormonal, and microbiota factors that contribute to this complex disorder.\n\nThe main questions it aims to answer are:\n\n* What specific alterations in the MGBA pathways are associated with BED?\n* Can psychobiotic supplementation effectively reverse microbiota alterations and modulate MGBA activity, ultimately improving BED symptoms? Researchers will compare participants receiving psychobiotics to those receiving a look-alike substance that contains no drug (a placebo) to evaluate whether psychobiotics impact endocrine hormones, neurofunction, psychological and behavioral factors related to eating regulation, and BED symptoms.\n\nParticipants will:\n\n* Undergo an assessment protocol that includes microbiota sampling, blood tests for hormone analysis, neurofunctional evaluations, and psychological\u002Fbehavioral assessments before and after the psychobiotics\u002F placebo intervention.\n* Take psychobiotics or a placebo daily for 12 weeks and receive well-being monitoring\n* Participate in follow-up visits three months after the intervention to monitor changes in BED symptoms and related parameters.",[100,101],"Binge Eating Disorder","Obesity",[103,104,105,101,106],"psychobiotic treatment","Study of neuro-psycho-biological mechanisms","Microbiota-Gut-Brain Axis (MGBA)","Binge eating disorder","NOT_YET_RECRUITING","2025-03-24",{"date":110,"type":111},"2025-03-28","ACTUAL",{"date":113,"type":94},"2025-04",{"date":115,"type":94},"2030-03",{"name":5,"class":6},1]