[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100544862":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":25,"locations":26,"responsibleParty":42,"collaborators":46,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":70,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":25,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":88,"overallStatus":93,"whyStopped":25,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"University of Skövde","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control group","ACTIVE_COMPARATOR","The control group comprises participants who do not receive the specific Mind diet intervention but undergo the same procedures as the intervention group, including weighing at the beginning and end of the study, completing identical questionnaires, and providing fecal samples at recruitment and follow-up. They will also use the same meal-planning app as the intervention group.",[13],"Behavioral: Dietary intervention based on the MIND diet",{"label":15,"type":16,"description":17,"interventionNames":18},"Intervention group","EXPERIMENTAL","The intervention group consists of participants who receive the Mind diet intervention. Like the control group, they will be weighed at the start and end of the study, answer the same questionnaires, and provide fecal samples at recruitment and follow-up. Additionally, they will use the same meal-planning app as the control group, but their dietary pattern will be based on the Mind diet.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Dietary intervention based on the MIND diet","A 12-week pilot randomized controlled trial (RCT) involving N=126 obese participants (1:1 gender ratio) to assess protocol feasibility, including recruitment, retention, compliance, physical examinations, and gut sample collection. Sample size, calculated by a statistician, expects a 5% body weight change at follow-up (std. dev. 10%). We chose a 12-week duration for this pilot study to allow sufficient time to observe significant changes in both body weight and mental health.",[9,15],null,[27],{"facility":5,"status":25,"city":28,"state":25,"zip":29,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":38},"Skövde","54128","Sweden","SE",{"type":33,"coordinates":34},"Point",[35,36],13.84506,58.39118,{"lat":36,"lon":35},[39],{"name":40,"role":41,"phone":25,"phoneExt":25,"email":25},"Gianluca Tognon, PhD","CONTACT",{"type":43,"investigatorFullName":44,"investigatorTitle":45,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Gianluca Tognon","Senior lecturer in public health sciences",[47,49,51,53,55,57,59],{"name":48,"class":6},"State University of New York - Downstate Medical Center",{"name":50,"class":6},"Albert Einstein College of Medicine",{"name":52,"class":6},"Göteborg University",{"name":54,"class":6},"Uppsala University",{"name":56,"class":6},"Kristianstad University",{"name":58,"class":6},"University of Pavia",{"name":60,"class":61},"The Food Scientist AB (Sweden)","UNKNOWN","100544862","the-mind-gut-digital-pilot-intervention-study-100544862",false,"NCT06374407","The MIND-GUT Digital Pilot Intervention Study","Exploring the Interplay Between Diet, Obesity, Mental Health, and the Gut Microbiome. The MIND-GUT Digital Pilot Intervention Study.","MINDGUT","Inclusion Criteria:\n\n* age 30- 50;\n* BMI ≥ 30 kg\u002Fm2;\n* stable physical activity;\n* one person per household;\n* commitment to full protocol.\n\nExclusion Criteria:\n\n* use of psychiatric medications (e.g., serotonin reuptake inhibitors);\n* use of weight loss medications (GLP-1 receptor agonists);\n* food allergies affecting adherence to the MIND diet;\n* diagnosis of eating disorders;\n* diagnosis of diabetes;\n* diagnosis of polycystic ovary syndrome;\n* sensory deficits (e.g., COVID-19-induced loss of taste\u002Fsmell);\n* antibiotic use during the latest 3 months;\n* participation in another study;\n* language understanding limitations (i.e., not able to understand either Swedish or English); - coeliac\u002Finflammatory bowel disease;\n* planned weight management program within three months;\n* pregnancy;\n* lactation;\n* menopause.",true,"ALL","30 Years","50 Years",{"count":75,"type":76},126,"ESTIMATED","INTERVENTIONAL",[79],"NA","This 12-week pilot study aims to evaluate the feasibility and effectiveness of a dietary intervention targeting diet, obesity, mental health, and the gut microbiome in promoting weight loss and enhancing mental health among obese men and women aged 30-50. Participants, excluding those with specific medical conditions, will be randomly assigned to either an intervention or control group using a meal planning smartphone app. Clinical assessments will include anthropometry, mental health questionnaires, dietary recalls, and stool sample collections. The study's endpoints include program retention, adherence, changes in body weight, mental health, and gut microbiome diversity. Statistical analyses will evaluate intervention effects and the potential mediating roles of the gut microbiome. This pilot study has implications for health policies, public healthcare, digital health companies, and the biotech and pharmacology industries. Future plans involve a large-scale intervention study in multiple countries with ongoing collaborations.",[82,83,84,85,86,87],"Obesity","Depressive Symptoms","Anxiety","Stress","Eating Habit","Dysbiosis",[89,90,91,92],"mental health","obesity","mind gut diet","gut microbiome","NOT_YET_RECRUITING","2024-04-15",{"date":96,"type":97},"2024-04-18","ACTUAL",{"date":99,"type":76},"2024-06",{"date":101,"type":76},"2026-12",{"name":5,"class":6},1]