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NCT Number: NCT07818369

Synbiotic LA-5 and Agave Inulin for Mild Cognitive Impairment

This pilot randomized, double-blind, crossover clinical trial will evaluate the effect of a synbiotic containing Lactobacillus acidophilus LA-5 and agave inulin on mild cognitive impairment (MCI) in adults aged 60-75 years attending the Defense Medical Specialties Unit. Forty participants with MCI will be randomized into two groups of 20 participants. The intervention will consist of daily administration of L. acidophilus LA-5 (4 × 10⁹ CFU), 7 g of agave inulin, and almond powder for 12 weeks, while the control group will receive almond powder as the vehicle. After a two-week washout period, participants will cross over to the alternate intervention for an additional 12 weeks.

Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA), Memory Alteration Test (M@T), and Mini-Mental State Examination (MMSE). Secondary assessments will explore potential mechanisms of the microbiota-gut-brain axis by measuring fecal L. acidophilus LA-5 and butyrate, as well as serum BDNF and inflammatory biomarkers including IL-1β, IL-6, IL-10, and TNF-α.

The study aims to determine whether synbiotic supplementation improves cognitive performance in older adults with MCI and whether these changes are accompanied by modifications in gut microbial activity, short-chain fatty acid production, neurotrophic signaling, and systemic inflammation.

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Key information

Conditions

Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unidad de Especialidades Médicas de la Defensa (UEMD)

Mexico City, 11200, Mexico

Location status: Recruiting

Location contact

Antonio Ibarra, PhD

CONTACT

[email protected]

55 54197603

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults aged 60 to 75 years.
  • Presence of mild cognitive impairment (MCI) determined by neuropsychological testing, meeting at least two of the following three established cutoff criteria:
  • Montreal Cognitive Assessment (MoCA): 19-26 points.
  • Memory Alteration Test (M@T): 28-37 points.
  • Mini-Mental State Examination (MMSE): 12-24 points.
  • Ability and willingness to provide written informed consent; consent may be provided by a family member or legal representative when necessary.

Exclusion criteria

  • Previous diagnosis of severe cognitive impairment, Alzheimer disease, vascular dementia, or another neurodegenerative disorder affecting cognition.
  • History of cerebral ischemia, cerebrovascular events, traumatic brain injury, or advanced-stage renal disease.
  • Diagnosis of type 2 diabetes mellitus.
  • Diagnosed dysbiosis or inflammatory bowel disease, including ulcerative colitis or Crohn disease.
  • Use of antibiotics, laxatives, probiotics, or prebiotics within the 3 months prior to enrollment.
  • Habitual consumption of fermented foods or fiber-rich supplements, particularly fiber intake >18 g/day.
  • Excessive alcohol consumption, defined as ≥2 alcoholic drinks per day, or history of alcohol dependence.
  • Chronic use of medications that may interfere with the microbiota-gut-brain axis, including immunosuppressants, antipsychotics, or corticosteroids.
  • Recent surgery within the previous 3 months or a planned medical intervention during the study period.
  • Known adverse reaction or hypersensitivity to any component of the synbiotic or to almond powder.
  • Uncontrolled chronic stress identified by clinical assessment.
  • Participation in intense physical activity or high-performance sports during the study.

Treatment and study plan

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

Dietary Supplement

Participants will receive 2 g of Lactobacillus acidophilus LA-5 (4 × 10⁹ CFU), 7 g of agave inulin, and 20 g of almond powder dissolved in water, administered orally once daily for 12 weeks.

Primary outcomes

  1. Change in Montreal Cognitive Assessment (MoCA) Score

    Time frame: Baseline, end of the first intervention phase, and end of the second intervention phase.

    The Montreal Cognitive Assessment (MoCA) will be used to assess changes in global cognitive function. The total score ranges from 0 to 30 points, with higher scores indicating better cognitive performance. A clinically meaningful improvement will be defined as an increase of at least 2 points from baseline, according to the study protocol.

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

    Time frame: : Baseline, end of the first intervention phase, and end of the second intervention phase.

    he Memory Alteration Test (M@T) will be used to assess changes in memory function. The total score ranges from 0 to 50 points, with higher scores indicating better memory performance. The test evaluates orientation and several memory domains, including semantic, free-recall, and cued-recall components. A clinically meaningful improvement will be defined as an increase of at least 2 points from baseline.

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

    Time frame: Baseline, end of the first intervention phase, and end of the second intervention phase.

    The Mini-Mental State Examination (MMSE) will be used to assess changes in global cognitive function. The total score ranges from 0 to 30 points, with higher scores indicating better cognitive performance. A clinically meaningful improvement will be defined as an increase of at least 1.5 points from baseline, according to the study protocol.

Secondary outcomes

  1. Change in Serum Brain-Derived Neurotrophic Factor (BDNF) Concentration

    Time frame: Baseline, end of the first intervention phase, and end of the second intervention phase.

    Serum brain-derived neurotrophic factor (BDNF) concentration will be quantified using enzyme-linked immunosorbent assay (ELISA). Results will be expressed in pg/mL. There is no predefined minimum or maximum score. Higher BDNF concentrations indicate greater circulating levels of this neurotrophic factor.

  2. Change in Interleukin-1 Beta (IL-1β) Concentration

    Time frame: Baseline, end of the first intervention phase, and end of the second intervention phase.

    IL-1β concentration will be quantified using ELISA and expressed in pg/mL. There is no predefined minimum or maximum score. Higher concentrations indicate greater levels of this pro-inflammatory cytokine.

  3. Change in Interleukin-6 (IL-6) Concentration

    Time frame: Baseline, end of the first intervention phase, and end of the second intervention phase.

    IL-6 concentration will be quantified using ELISA and expressed in pg/mL. There is no predefined minimum or maximum score. Higher concentrations indicate greater levels of this pro-inflammatory cytokine.

  4. Change in Tumor Necrosis Factor Alpha (TNF-α) Concentration

    Time frame: Baseline, end of the first intervention phase, and end of the second intervention phase.

    TNF-α concentration will be quantified using ELISA and expressed in pg/mL. There is no predefined minimum or maximum score. Higher concentrations indicate greater levels of this pro-inflammatory cytokine.

  5. Change in Interleukin-10 (IL-10) Concentration

    Time frame: Baseline, end of the first intervention phase, and end of the second intervention phase.

    IL-10 concentration will be quantified using ELISA and expressed in pg/mL. There is no predefined minimum or maximum score. Higher concentrations indicate greater levels of this anti-inflammatory cytokine.

  6. Change in Fecal Butyrate Concentration

    Time frame: Baseline, end of the first intervention phase, and end of the second intervention phase.

    Fecal butyrate concentration will be quantified using gas chromatography with flame ionization detection (GC-FID). Results will be expressed in mmol/g of fecal sample. There is no predefined minimum or maximum score. Higher concentrations indicate greater fecal butyrate production.

  7. Change in Fecal Lactobacillus acidophilus LA-5 Count

    Time frame: Baseline, end of the first intervention phase, and end of the second intervention phase.

    Fecal Lactobacillus acidophilus LA-5 will be quantified by colony-forming unit counts using selective MRS culture medium under anaerobic conditions. Results will be expressed as CFU/g of fecal sample. There is no predefined minimum or maximum score. Higher values indicate greater fecal abundance of L. acidophilus LA-5.

Study contacts

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

Antonio Ibarra, PhD

CONTACT

[email protected]

52 55 54197603

Sponsors and collaborators

Lead sponsor

Anahuac University

Other

Registry information

Official study title

Effect of a Symbiotic (Lactobacillus Acidophilus LA-5 and Agave Inulin) on Mild Cognitive Impairment in Older Adults of the Defense Medical Specialties Unit

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 14, 2026
Registry last updated
Sep 14, 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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