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RecruitingNCT07810517Updated Sep 10, 2026

Lactobacillus Acidophilus and Inulin for Cognitive Impairment in Obesity

An interventional study of Synbiotic (Lactobacillus acidophilus LA-5 and Agave Inulin) in Obesity (Disorder), sponsored by Anahuac University. Recruiting at 1 site in Mexico. Open to participants aged 30 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by Anahuac University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
30 Years to 40 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Obesity (Disorder)

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03

Who can participate

Ages eligible
30 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Synbiotic - Control

    Participants will initially receive the synbiotic intervention and subsequently cross over to the control intervention.

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

  • Experimental
    Control - Synbiotic

    Participants will initially receive the synbiotic intervention and subsequently cross over to the control intervention.

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

Interventions

  • Dietary supplementSynbiotic (Lactobacillus acidophilus LA-5 and Agave Inulin)

    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.

05

What researchers measure

Primary outcomes

  1. Change in Montreal Cognitive Assessment (MoCA) Score

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

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

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

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

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

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

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

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

06

Study locations

1 of 1 sites recruiting
  • Universidad Anahuac
    Huixquilucan, State of Mexico 52786, Mexico
    Recruiting
07

Registry details

Key details

Study ID
NCT07810517
Lead sponsor
Anahuac University
Responsible party
Jose Juan Antonio Ibarra Arias (Principal Investigator, Anahuac University) — Principal investigator
First posted
Sep 9, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
Feb 2, 2027 (estimated)
Completion
Jun 1, 2027 (estimated)
Last update
Sep 10, 2026

Study contacts

Antonio Ibarra, PhD
Contact
jose.ibarra@anahuac.mx
52 5554197603

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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