Synbiotic LA-5 and Agave Inulin for Mild Cognitive Impairment

NCT07818369 | Recruiting

• 1 other identifier: CEI202513
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cognitive Impairment

Outcome Measures

Primary Outcomes (3)

• Change in Montreal Cognitive Assessment (MoCA) Score

  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.

  Baseline, end of the first intervention phase, and end of the second intervention phase.

• Change in Memory Alteration Test (M@T) Score

  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.

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

• Change in Mini-Mental State Examination (MMSE) Score

  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.

  Baseline, end of the first intervention phase, and end of the second intervention phase.

Secondary Outcomes (7)

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

  Baseline, end of the first intervention phase, and end of the second intervention phase.

• Change in Interleukin-1 Beta (IL-1β) Concentration

  Baseline, end of the first intervention phase, and end of the second intervention phase.

• Change in Interleukin-6 (IL-6) Concentration

  Baseline, end of the first intervention phase, and end of the second intervention phase.

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

  Baseline, end of the first intervention phase, and end of the second intervention phase.

• Change in Interleukin-10 (IL-10) Concentration

  Baseline, end of the first intervention phase, and end of the second intervention phase.

Study Arms (2)

Synbiotic and Control

EXPERIMENTAL

Participants will receive the synbiotic intervention once daily for 12 weeks. The synbiotic consists of 2 g of Lactobacillus acidophilus LA-5 (4 × 10⁹ CFU), 7 g of agave inulin, and 20 g of almond powder dissolved in water. After the first 12-week intervention period, participants will undergo a 2-week washout period and will then cross over to the control intervention, consisting of 29 g of almond powder dissolved in water once daily for 12 weeks.

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

Control and Synbiotic

EXPERIMENTAL

Participants will receive the control intervention, consisting of 29 g of almond powder dissolved in water once daily for 12 weeks. After a 2-week washout period, participants will cross over to the synbiotic intervention and 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 once daily for 12 weeks.

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

Interventions

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.

Control and Synbiotic; Synbiotic and Control

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anahuac University: lead

Study Sites (1)

Unidad de Especialidades Médicas de la Defensa (UEMD)

Mexico City, Mexico City, 11200, Mexico

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Synbiotics

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Prebiotics; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Probiotics; Food and Beverages

Central Study Contacts

Antonio Ibarra, PhD

CONTACT

52 55 54197603; jose.ibarra@anahuac.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 8, 2026
• First Posted: September 14, 2026
• Study Start (Estimated): December 31, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: September 14, 2026

Record last verified: 2026-09

Locations

ME (1)