NCT07810517

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Nov 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 9, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2026

Expected
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2027

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

September 10, 2026

Status Verified

September 1, 2026

Enrollment Period

3 months

First QC Date

September 3, 2026

Last Update Submit

September 8, 2026

Conditions

Obesity (Disorder)

Outcome Measures

Primary Outcomes (3)

  • Change in Montreal Cognitive Assessment (MoCA) Score

    The total score ranges from 0 to 30 points, with higher scores indicating better cognitive performance

    Baseline, Week 12, and Week 26.

  • Change in Mini-Mental State Examination (MMSE) Score

    The total score ranges from 0 to 30 points, with higher scores indicating better cognitive performance.

    Baseline, Week 12, and Week 26.

  • Change in Memory Alteration Test (M@T) Score

    The total score ranges from 0 to 50 points, with higher scores indicating better memory performance.

    Baseline, Week 12, and Week 26.

Study Arms (2)

Synbiotic - Control

EXPERIMENTAL

Participants will initially receive the synbiotic intervention and subsequently cross over to the control intervention.

Dietary Supplement: Synbiotic (Lactobacillus acidophilus LA-5 and Agave Inulin)

Control - Synbiotic

EXPERIMENTAL

Participants will initially receive the synbiotic intervention and subsequently cross over to the control intervention.

Dietary Supplement: Synbiotic (Lactobacillus acidophilus LA-5 and Agave Inulin)

Interventions

Synbiotic (Lactobacillus acidophilus LA-5 and Agave Inulin)DIETARY_SUPPLEMENT

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.

Control - SynbioticSynbiotic - Control

Eligibility Criteria

Age30 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Anahuac

Huixquilucan, State of Mexico, 52786, Mexico

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Synbiotics

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PrebioticsDietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaProbioticsFood and Beverages

Central Study Contacts

Antonio Ibarra, PhD

CONTACT

52 5554197603jose.ibarra@anahuac.mx

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 3, 2026

First Posted

September 9, 2026

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

February 2, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

September 10, 2026

Record last verified: 2026-09

Locations

ME(1)