[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Max Planck Institute for Human Cognitive and Brain Sciences\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":114},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,57,91],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":31,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":56},"100631491","effects-of-a-6-months-fiber--and-polyphenol-rich-diet-on-brain-inflammatory-processes-in-perimenopausal-women-living-with-overweight-or-obesity-100631491",false,"NCT07501377","Effects of a 6-months Fiber- and Polyphenol-rich Diet on Brain Inflammatory Processes in Perimenopausal Women Living With Overweight or Obesity","Effects of a Fiber- and Polyphenol-rich Diet on Brain Inflammatory Processes in Obesity","INFLAME","Inclusion Criteria:\n\n* STRAW+10 -1 or -2\n* BMI \\> 25 or WHR \\>= 0.85\n* hsCRP \\> 1 mg\u002Fl\n* no MRI contra-indication\n* written informed consent\n\nExclusion Criteria:\n\n* occurrence of a clinically relevant psychiatric disease in the last 12 months (e.g., depression, substance abuse, eating disorder, schizophrenia)\n* type 1 diabetes\n* previous bariatric\u002Fgastric surgery\n* pregnancy or breastfeeding woman\n* severe untreated disease, cancer treatment last 12 months, any chronic gastric tract disease (IBS, Morbus Crohn, Heliobacter pylori Infection etc.) or any chronic inflammatory disease\n* Polycystic ovary syndrome, total ovarectomy\n* Intake of antibiotics in past 3 months, intake of inulin (\\>5g\u002Fday) or polyphenol supplementation (\\>50mg\u002Fday) in past 3 months",true,"FEMALE","35 Years","60 Years",{"count":22,"type":23},120,"ESTIMATED","INTERVENTIONAL",[26],"NA","People living with obesity have a higher risk of late-life cognitive decline and developing dementia. In women, the risk of cognitive decline may further raise during the menopausal transition, a period of substantial hormonal and metabolic changes.\n\nRecent studies suggest that a healthy diet could help to prevent neurocognitive disorders by reducing inflammatory processes in the body and brain. Emerging evidence further indicates that the gut-brain axis and the intestinal microbiome play a crucial role in mediating this effect, through metabolic, immune, neuronal and vascular routes. Modifying the gut microbiota may thus counteract the heightened systemic inflammation seen in obesity and during menopausal transition to eventually benefit brain health.\n\nSpecifically, plant-based nutirents, such as fibre and polyphenols, have microbiome-changing, anti-inflammatory and neuroprotective properties that may slow brain aging and neuro-inflammation. However, evidence from human interventional studies and knowledge on the underlying mechanisms remain scarce.\n\nThis randomized controlled trial will therefore test whether altering gut bacteria through six months of daily intake of a personalized \"polybiotic\" dietary formula, compared to placebo, improves markers of brain health in women during the perimenopausal transition that are living with overweight or obesity. We plan to enroll 120 women aged 35-60 with overweight\u002Fobesity and elevated inflammatory blood markers, randomized to: intervention (7.5 or 15 g inulin, plus 200 mg resveratrol and 320 mg quercetin per day in powder form with main meals) or control (isocaloric maltodextrin). Exclusions include type 1 diabetes, current psychiatric\u002Fgastrointestinal disorders, and magentic resonance imaging (MRI) contraindications.\n\nBefore and after 26 weeks, participants will undergo brain MRI to assess inflammation-related brain markers, neuropsychological testing, anthropometric measurements, they will fill in a set of questionnaires and donate stool and blood. Gut bacteria will be profiled by next-generation sequencing; metabolites will be measured in blood and stool. The primary outcome is a proxy of neuroinflammation in the white matter assessed using diffusion-weighted MRI. Secondary analyses will examine blood-brain-barrier permeability and other functional and structural MRI measures, including MR spectoscropy. Mechanistic links among changes in inflammatory markers, microbiota composition, and short-chain fatty acids will be explored using path and network models.\n\nThis study may help to develop novel prevention and treatment strategies to mitigate obesity-related cognitive decline via the gut-brain axis.",[29,30],"Overweight and\u002For Obesity","Perimenopausal Women",[32,33,34,35,36,37,38,39,40,41,42,43],"neuroinflammation","obesity","overweight","menopausal transition","gut-brain axis","diet","diffusion-weighted MRI","cognitive decline","brain aging","MR spectroscopy","prevention","open science","RECRUITING","2026-03-26",{"date":47,"type":48},"2026-03-30","ACTUAL",{"date":50,"type":48},"2026-03-19",{"date":52,"type":23},"2030-12-31",{"name":54,"class":55},"Max Planck Institute for Human Cognitive and Brain Sciences","OTHER",1,{"id":58,"slug":59,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":4,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":4,"studyType":24,"phases":69,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":88,"leadSponsor":90,"locationsCount":56},"100525069","magnetic-brain-stimulation-and-computer-based-motor-training-for-rehabilitation-after-stroke-100525069","NCT06116942","Magnetic Brain Stimulation and Computer-based Motor Training for Rehabilitation After Stroke","Repetitive Transcranial Magnetic Stimulation for Enhancing Brain Computer Interphase-induced Plasticity in Stroke: a Crossover Design","Inclusion Criteria:\n\n1. Diagnosis of a subcortical stroke at least 6 months before the initiation of the trial and confirmed with magnetic resonance imaging (MRI) or computed tomography\n2. Present moderate to severe hemiparesis in an upper limb\n3. Language comprehension as well as visual and auditory perception sufficient to engage in Brain Computer Interface training\n4. Age from 20 to 80 years old\n5. Clear consciousness and stable vital signs\n6. Eligible for MRI, EEG, BCI and TMS methods\n\nExclusion Criteria:\n\n1. Drug abuse or recent changes in medications that may alter the central nervous system when the measurements begin or during the measurements (e.g., benzodiazepines, serotoninergic and dopaminergic agents)\n2. History of seizure\n3. Bone, joint and muscle diseases\n4. Peripheral neuropathy or other neurological or psychiatric diseases (including, tinnitus, migraine, or mood disorders with the exception of minimal, mild, and moderate depression, reflected as a Beck depression scale score lower than 29).\n5. Strong cognitive deficits (including speech, attention, hearing, vision, sensation or intelligence deficits) reflected as a Montreal Cognitive Assessment (MoCA) score lower or equal to 24\n6. Lesions in the upper extremities\n7. Bone, joint and muscle diseases\n8. Severe spasticity (higher than 3) or pain in the upper limb and affecting wrist extension\n9. Contraindications of undergoing TMS examinations: history of seizures, history of epilepsy, unclear unconsciousness, migraines or metals on the head\n10. Contraindications for MRI: metals in the body, metallic prosthetics or claustrophobia\n11. Participation in other interventional trials using BCI or rTMS within less than 6 months ago\n12. Participation in another interventional clinical trial\n13. Suspected lack of compliance\n14. Pregnant or nursing women","ALL","20 Years","80 Years",{"count":68,"type":23},24,[26],"The goal of the present clinical trial is to explore whether an innovative technology-based approach can help individuals who have had a stroke and can no longer move their hands with ease. Our approach consists of a combination of two technologies: Transcranial Magnetic Stimulation (TMS) and a Brain-Computer Interface (BCI). The former entails the application of magnetic fields over the head to stimulate the brain preparing it for a better ability to produce movement. The latter consists of measuring brain activity to personalize a type of computer-based training that is designed to increase communication between the brain and the muscles.",[72],"Chronic Stroke",[74,75,76,77,78,79,80,81,82,83],"Transcranial Magnetic Stimulation","Intermittent Theta Burst Stimulation","Brain-Computer Interface","Rehabilitation","EEG","MRI","Molecular changes","Brain plasticity","Stroke","Hemiparesis","2023-11-08",{"date":86,"type":48},"2023-11-09",{"date":84,"type":23},{"date":89,"type":23},"2027-09-19",{"name":54,"class":55},{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":17,"sex":64,"minAge":99,"maxAge":20,"enrollmentInfo":100,"targetDuration":4,"studyType":24,"phases":102,"briefSummary":103,"conditions":104,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":56},"100466420","impact-of-microbiome-changing-interventions-on-food-decision-making-100466420","NCT05353504","Impact of Microbiome-changing Interventions on Food Decision-making","\"SFB 1052\u002F3 - Mechanismen Der Adipositas, Projekt A1: Veränderung Der Neurobiologischen Grundlagen Von Ess-Entscheidungen Bei Adipositas\" Engl. \"CRC 1052\u002F3 - Obesity Mechanisms, Project A1: Targeting Neurobehavioral Determinants of Obesity\"","MIFOOD","Inclusion Criteria:\n\n* BMI \\>= 25 kg\u002Fm2 or WHR \\>= 0.9\u002F0.85 (m\u002Fd, f)\n* no MRI contra-indication\n* written informed consent\n\nExclusion Criteria:\n\n* athletes\n* occurrence of a clinically relevant psychiatric disease in the last 12 months, e.g. depression, substance abuse, eating disorders, schizophrenia\n* any chronic inflammatory or malignant disease\n* type 1 diabetes\n* previous bariatric\u002Fgastric surgery\n* pregnancy or breastfeeding woman","18 Years",{"count":101,"type":23},90,[26],"The investigators aim to test the hypothesis that a microbiome-changing dietary intervention improves food decision-making and to determine the underlying microbiotal and metabolic mechanisms. To this end, 90 overweight\u002Fobese adults will be enrolled in a randomized controlled trial to test the effects of a pre-biotic dietary intervention (supplementary intake of soluble fibre) or a behavioural lifestyle intervention (weekly educational program) vs. control condititon (supplementary intake of isocaloric starch) over a period of 26 weeks. Before and after the intervention\u002Fcontrol period, participants will undergo task-based functional and structural MRI and cognitive testing. The gut microbiota will be assessed using 16S rDNA next-generation sequencing (V3\u002FV4 region) in stool samples. Diet, anthropometry and lifestyle will be monitored with questionnaires and metabolomics will be assayed in peripheral blood and stool (e.g. SCFA). Using a modulation of gut-brain communication through a prebiotic diet and lifestyle intervention, respectively, the investigators will be able to discover microbiota communities that play a key role for eating behaviour. Related mechanistic insights could help to develop novel preventive and therapeutic options to combat unhealthy weight gain in our obesogenic society.",[105],"Overweight and Obesity","2022-04-26",{"date":108,"type":48},"2022-04-29",{"date":110,"type":48},"2022-03-08",{"date":112,"type":23},"2026-12",{"name":54,"class":55},""]