Lactobacillus Acidophilus and Inulin for Cognitive Impairment in Obesity
ConditionObesity (Disorder)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-40
SponsorAnahuac University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
Synbiotic (Lactobacillus acidophilus LA-5 and Agave Inulin)
Dietary supplementParticipants 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Synbiotic - ControlExperimental treatment 1 intervention
Group B: Control - SynbioticExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Montreal Cognitive Assessment (MoCA) Score
The total score ranges from 0 to 30 points, with higher scores indicating better cognitive performance
Time frame
Baseline, Week 12, and Week 26.2
Change in Mini-Mental State Examination (MMSE) Score
The total score ranges from 0 to 30 points, with higher scores indicating better cognitive performance.
Time frame
Baseline, Week 12, and Week 26.3
Change in Memory Alteration Test (M@T) Score
The total score ranges from 0 to 50 points, with higher scores indicating better memory performance.
Time frame
Baseline, Week 12, and Week 26.Sponsors and contacts
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Source ClinicalTrials.gov