Obesity (Disorder)
Conditions
Brief 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.
Interventions
DIETARY_SUPPLEMENTSynbiotic (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.
Sponsors
Anahuac University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Mexico
Contacts
CONTACTAntonio Ibarra, PhD
Outcome results
None listed