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