Synbiotic (Lactobacillus acidophilus LA-5 and Agave Inulin)
Synbiotic (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.
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.
Eligibility
Sex
ALL
Min age
30 Years
Max age
40 Years
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:
* 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.
Primary outcome measure(s)
Change in Montreal Cognitive Assessment (MoCA) Score — Baseline, Week 12, and Week 26. The total score ranges from 0 to 30 points, with higher scores indicating better cognitive performance
Change in Mini-Mental State Examination (MMSE) Score — Baseline, Week 12, and Week 26. The total score ranges from 0 to 30 points, with higher scores indicating better cognitive performance.
Change in Memory Alteration Test (M@T) Score — Baseline, Week 12, and Week 26. The total score ranges from 0 to 50 points, with higher scores indicating better memory performance.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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