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NCT Number: NCT07810517

Lactobacillus Acidophilus and Inulin for Cognitive Impairment in Obesity

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.

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Key information

Conditions

Obesity (Disorder) Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Anahuac

Huixquilucan, State of Mexico, 52786, Mexico

Location status: Recruiting

Location contact

Antonio Ibarra, PhD

CONTACT

[email protected]

52 55 54197603

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Synbiotic (Lactobacillus acidophilus LA-5 and Agave Inulin)

Dietary Supplement

Participants will receive 2 g of Lactobacillus acidophilus (4 × 10⁹ CFU) plus 7 g of agave inulin, combined with 20 g of a powder containing almond, cinnamon, vanilla, and oats, dissolved in water and administered once daily for 12 weeks.

Primary outcomes

  1. Change in Montreal Cognitive Assessment (MoCA) Score

    Time frame: Baseline, Week 12, and Week 26.

    The total score ranges from 0 to 30 points, with higher scores indicating better cognitive performance

  2. Change in Mini-Mental State Examination (MMSE) Score

    Time frame: Baseline, Week 12, and Week 26.

    The total score ranges from 0 to 30 points, with higher scores indicating better cognitive performance.

  3. Change in Memory Alteration Test (M@T) Score

    Time frame: Baseline, Week 12, and Week 26.

    The total score ranges from 0 to 50 points, with higher scores indicating better memory performance.

Study contacts

Contact information is provided by the study sponsor or research team.

Antonio Ibarra, PhD

CONTACT

[email protected]

52 5554197603

Sponsors and collaborators

Lead sponsor

Anahuac University

Other

Registry information

Official study title

Effect of Lactobacillus Acidophilus Combined With Inulin on Cognitive Impairment in Patients With Obesity

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 9, 2026
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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