Synbiotic LA-5 and Agave Inulin for Mild Cognitive Impairment
ConditionCognitive Impairment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-75
SponsorAnahuac University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 60 to 75 years.
Montreal Cognitive Assessment (MoCA): 19-26 points.
Memory Alteration Test (M@T): 28-37 points.
Mini-Mental State Examination (MMSE): 12-24 points.
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
Synbiotic (Lactobacillus acidophilus LA-5 and Agave Inulin) Intervention Type:
Dietary supplementParticipants 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.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Synbiotic and ControlExperimental treatment 1 intervention
Group B: Control and SynbioticExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, end of the first intervention phase, and end of the second intervention phase.2
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.
Time frame
: Baseline, end of the first intervention phase, and end of the second intervention phase.3
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.
Time frame
Baseline, end of the first intervention phase, and end of the second intervention phase.Secondary outcomes
1
Change in Serum Brain-Derived Neurotrophic Factor (BDNF) Concentration
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.
Time frame
Baseline, end of the first intervention phase, and end of the second intervention phase.2
Change in Interleukin-1 Beta (IL-1β) Concentration
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.
Time frame
Baseline, end of the first intervention phase, and end of the second intervention phase.3
Change in Interleukin-6 (IL-6) Concentration
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.
Time frame
Baseline, end of the first intervention phase, and end of the second intervention phase.4
Change in Tumor Necrosis Factor Alpha (TNF-α) Concentration
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.
Time frame
Baseline, end of the first intervention phase, and end of the second intervention phase.Sponsors and contacts
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Source ClinicalTrials.gov