Clinical trials

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. The 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. This 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. The 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.

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. Several 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. After 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.