Lactobacillus Acidophilus and Inulin for Cognitive Impairment in Obesity

Recruiting · NCT07810517 · Interventional (participants receive a specific treatment)

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Interventions studied

Synbiotic (Lactobacillus acidophilus LA-5 and Agave Inulin)

What this trial is about

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.

Who can take part

Age range

30 Years to 40 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

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.

Where it is running

1 location listed.

Universidad Anahuac - Huixquilucan, State of Mexico, Mexico

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →