๐ฌIn plain words
What the trial is, and whether it could suit you
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 ร 10โน 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 o
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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 โฅ2 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.
๐
What it tests
- Synbiotic (Lactobacillus acidophilus LA-5 and Agave Inulin) Intervention Type:
Unidad de Especialidades Mรฉdicas de la Defensa (UEMD)
Mexico City, Mexico
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.