Synbiotic (Lactobacillus acidophilus LA-5 and Agave Inulin) / Obesity (disorder) · Interventional Study

Lactobacillus Acidophilus and Inulin for Cognitive Impairment in Obesity

ClinicalTrials.gov · September 10, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a clinical trial registry record for a planned randomized crossover study evaluating a synbiotic (Lactobacillus acidophilus and inulin) on cognitive function in adults with obesity. The trial is actively recruiting and no outcome data have been published or posted in this registry record.

What was studied

Interventional, Randomized, Crossover, Double masking, Treatment purpose. Obesity (Disorder); age from 30 Years; to 40 Years. Intervention: Synbiotic - Control; Control - Synbiotic. Compared with: Control preparation (unspecified composition). n = 40. 1 site: Mexico.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a study registration with no reported results; the trial is actively recruiting and cognitive outcomes have not yet been assessed or published.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Change in Montreal Cognitive Assessment (MoCA) Score (assessed at Baseline, Week 12, and Week 26.); Change in Mini-Mental State Examination (MMSE) Score (assessed at Baseline, Week 12, and Week 26.); Change in Memory Alteration Test (M@T) Score (assessed at Baseline, Week 12, and Week 26.)

DesignInterventional, Randomized, Crossover, Double masking, Treatment purpose

PopulationObesity (Disorder); age from 30 Years; to 40 Years

Sample size40

InterventionSynbiotic - Control; Control - Synbiotic

ComparatorControl preparation (unspecified composition)

Setting1 site: Mexico

Reported figures

Quoted from the source exactly as published.

Planned sample size40

Age range30-40 years

Primary outcome measure 1Montreal Cognitive Assessment (MoCA) Score at Baseline, Week 12, Week 26

Primary outcome measure 2Mini-Mental State Examination (MMSE) Score at Baseline, Week 12, Week 26

Primary outcome measure 3Memory Alteration Test (M@T) Score at Baseline, Week 12, Week 26

Caveats

This is a registry record; no trial results have been reported or published.
No blinding strategy, allocation concealment method, or other methodological details are described in the registry.
Sample size is small (n=40); power calculations are not reported.
Crossover design may introduce carryover effects; washout period not specified in registry record.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Randomized crossover design planned; appropriate for within-subject comparisons.

Directness

moderate

Targets cognitive function in obesity via gut-microbiota mechanism; clinical endpoints chosen.

Consistency

insufficient

Registry record only; no results reported, consistency cannot be assessed.

Risk of bias

insufficient

No methodological detail on blinding, allocation concealment, or conduct reported.

Sample adequacy

limited

Estimated enrollment 40 participants; small sample for cognitive intervention trial.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07810517). This is a study registration, not published results. Lead sponsor: Anahuac University. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 40 participants (ESTIMATED). Conditions: Obesity (Disorder). Interventions: DIETARY_SUPPLEMENT: Synbiotic (Lactobacillus acidophilus LA-5 and Agave Inulin). Primary outcome measures: Change in Montreal Cognitive Assessment (MoCA) Score , Baseline, Week 12, and Week 26.; Change in Mini-Mental State Examination (MMSE) Score , Baseline, Week 12, and Week 26.; Change in Memory Alteration Test (M@T) Score , Baseline, Week 12, and Week 26.. 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Synbiotic (Lactobacillus acidophilus LA-5 and Agave Inulin)Anahuac UniversityNCT07810517Obesity (disorder)