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Lactobacillus Acidophilus and Inulin for Cognitive Impairment in Obesity
Lactobacillus Acidophilus and Inulin for Cognitive Impairment in Obesity

NCT07810517

RecruitingNA

Sponsor: Anahuac University

Conditions: Obesity (Disorder)

Interventions: Synbiotic (Lactobacillus acidophilus LA-5 and Agave Inulin)

Countries: Mexico

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 overview

Sex: ALL

Age: 30 Years to 40 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (1)
  • Huixquilucan, State of Mexico, Mexico