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Recruiting NCT07810517

Lactobacillus Acidophilus and Inulin for Cognitive Impairment in Obesity

Conditions: Obesity (Disorder)

Sex: All
Ages: 30 Years – 40 Years
Healthy volunteers: No
Phase: NA
Enrollment: 40
Sponsor: Anahuac University

Location: Universidad Anahuac Huixquilucan State of Mexico

Summary

This randomized crossover clinical trial aims to evaluate the effect of a synbiotic containing Lactobacillus acidophilus and inulin on cognitive function in adults with obesity and mild cognitive impairment. Forty participants aged 30-40 years will be randomly assigned to two groups. Participants will receive either the synbiotic intervention or a control preparation, followed by crossover to the alternate intervention. Cognitive function will be evaluated using the Montreal Cognitive Assessment (MoCA), Mini-Mental State Examination (MMSE), and Memory Alteration Test (M@T). Fecal butyrate and Lactobacillus acidophilus, as well as serum inflammatory cytokines and BDNF, will also be assessed to explore potential mechanisms involving the gut-brain axis.

Eligibility Criteria

Inclusion Criteria: * Adults aged 30 to 40 years. * Diagnosis of obesity for more than 10 years. * Presence of mild cognitive impairment, evaluated using cognitive assessment scales. * BMI ≥30 kg/m². * Body fat percentage ≥35% in women and ≥25% in men. * Willingness to participate and provide written informed consent. Exclusion Criteria: * Advanced cognitive impairment. * Diseases associated with cognitive impairment, including Alzheimer's disease, cerebral ischemia, cerebrovascular events, severe traumatic brain injury, or motor deficits. * Antibiotic use during the 3 months prior to treatment. * Allergy to almonds or any component of the synbiotic or vehicle. * Consumption of probiotics or supplements and/or frequent intake of high-fiber or fermented foods. * Diagnosed gastrointestinal disorders, including irritable bowel syndrome or inflammatory bowel disease, that could influence study outcomes. * Diagnosis of type 2 diabetes mellitus.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07810517). StuddyBuddy aggregates publicly available trial information.