ClinicalTrials.gg
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

In context

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's planned enrollment of 40 is below the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Anahuac University is the lead sponsor of 10 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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.
  • ≥30 kg/m².
  • Body fat percentage ≥35% in women and ≥25% in men.
  • Willingness to participate and provide written .

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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

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.

06

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.

07

Study locations

1 of 1 sites recruiting
  • Universidad Anahuac
    Huixquilucan, State of Mexico 52786, Mexico
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

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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