[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Anahuac University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":69},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":4},"100579940","supplementation-of-inulin--l-acidophilus-in-elders-with-t2dm-100579940",false,"NCT06830824","Supplementation of Inulin + L. Acidophilus in Elders with T2DM","Effect of Supplementation of a Symbiotic (Inulin + Lactobacillus Acidophilus) on Cognitive Impairment in Older Adults with Type 2 Diabetes Mellitus","Inclusion Criteria:\n\n* Patients between 60-90 years of age with a diagnosis of DM2 who present some degree of cognitive impairment, assessed with the scales.\n* Patients who sign the informed consent form.\n\nExclusion Criteria:\n\n* Patients who in the development of the study present comorbidities that influence cognitive impairment.\n* Patients who present adverse effects to supplementation.\n* Patients who decide to abandon the study or withdraw informed consent. - -Patients who do not take the symbiotic for 3 consecutive doses.",true,"ALL","60 Years","90 Years",{"count":21,"type":22},48,"ESTIMATED","INTERVENTIONAL",[25],"NA","This study investigates the effects of a symbotic supplement (Inulin + Lactobacillus acidophilus) on cognitive impairment in older adults with type 2 diabetes mellitus (T2DM). Diabetes is a chronic disease characterized by insulin deficiency or resistance, leading to hyperglycemia and long-term complications, including cognitive decline. Cognitive impairment in T2DM patients is linked to oxidative stress, neuroinflammation, and disrupted insulin signaling in the brain.\n\nThe gut-brain axis plays a crucial role in cognition, with gut microbiota influencing neuroinflammatory processes. Dysbiosis, common in T2DM, exacerbates cognitive decline. Probiotics like Lactobacillus acidophilus and prebiotics like inulin can restore gut microbiota balance, reduce inflammation, and promote brain-derived neurotrophic factor (BDNF) production, improving cognitive function.\n\nThis randomized, crossover clinical trial will enroll 24 patients aged 50-65 with T2DM and mild cognitive impairment. Participants will be divided into control and experimental groups, with an 8-week intervention phase followed by a crossover. The experimental group will receive 8g of inulin and L. acidophilus daily, while the control group will receive a placebo. Cognitive assessments (MMSE, MoCA), PET-CT imaging, gut microbiota sequencing, and butyrate measurements will evaluate the intervention's effects.\n\nThe study aims to determine whether symbiotic supplementation can improve cognitive function and metabolic brain activity in T2DM patients. If successful, it may offer an accessible, non-pharmacological approach to mitigating diabetes-related cognitive decline. The research is funded by the Universidad Anáhuac Health Sciences Research Center and international diabetes research organizations.",[28,29,30],"Diabetes Mellitus","Microbiome","Cognition Disorders",[28,32,33],"Supplementation","Cognitive impairment","NOT_YET_RECRUITING","2025-02-17",{"date":37,"type":38},"2025-02-19","ACTUAL",{"date":40,"type":22},"2025-03",{"date":42,"type":22},"2025-12",{"name":44,"class":45},"Anahuac University","OTHER",{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":16,"sex":17,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100492167","effect-of-the-administration-of-a-symbiotic-e-faecium-and-agave-inulin-on-mild-cognitive-impairment-in-older-adults-100492167","NCT05688618","Effect of the Administration of a Symbiotic (E. Faecium and Agave Inulin) on Mild Cognitive Impairment in Older Adults","Inclusion Criteria:\n\n* Patients with mild cognitive impairment\n* Patients who sign the informed consent\n\nExclusion Criteria:\n\n* Patients who do not have mild cognitive impairment\n* Patients with advanced cognitive impairment such as Alzheimers disease\n* Patients with comorbidities that influence the cognitive functions such as diabetes mellitus, cerebral ischemia or previous brain trauma\n* Patients who do not sign the informed consent","70 Years","85 Years",{"count":21,"type":22},[25],"Cognitive impairment is one of the fastest growing diseases in the last decades, given the significant increase in senior citizen population in Mexico and the world.\n\nSeveral studies have discussed the gut-microbiota-brain axis. It has been demonstrated that a balanced gut microbiota, prevents an increase in pro-inflammatory cytokines that affect specific brain areas; having an important impact at the cortical level of the hippocampus which translates to diminished cognitive function and the start of cognitive impairment symptoms.\n\nAfter multiple studies on the effect of the administration of symbiotics in animal models in cognition and memory, there have been positive results, observing improvement in cognition and decrement in inflammatory cytokines at hippocampus level.",[58],"Cognitive Impairment","RECRUITING","2024-07-29",{"date":62,"type":38},"2024-07-30",{"date":64,"type":38},"2022-11-16",{"date":66,"type":22},"2024-10-20",{"name":44,"class":45},1,""]