Obesity (Disorder)NCT07810517
Lactobacillus Acidophilus and Inulin for Cognitive Impairment in Obesity
A study testing Synbiotic (Lactobacillus acidophilus LA-5 and Agave Inulin) in people with Obesity (Disorder), run by Anahuac University at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 40 years
- Conditions the study is for
- Obesity (Disorder)
- What is being tested?
- Synbiotic (Lactobacillus acidophilus LA-5 and Agave Inulin)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteMexico
- Study dates
- 1 Nov 2026to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Universidad Anahuac
Huixquilucan, State of Mexico, 52786
Antonio Ibarra, PhD, 52 55 54197603, jose.ibarra@anahuac.mx
About this study
Official title: Effect of Lactobacillus Acidophilus Combined With Inulin on Cognitive Impairment in Patients With Obesity
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.
- Conditions
- Obesity (Disorder)
- Being tested
- Synbiotic (Lactobacillus acidophilus LA-5 and Agave Inulin)
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Synbiotic - Control | Experimental | Participants will initially receive the synbiotic intervention and subsequently cross over to the control intervention. Receives: 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. Receives: Dietary Supplement: Synbiotic (Lactobacillus acidophilus LA-5 and Agave Inulin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Montreal Cognitive Assessment (MoCA) Score
The total score ranges from 0 to 30 points, with higher scores indicating better cognitive performance
Measured: 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.
Measured: 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.
Measured: Baseline, Week 12, and Week 26.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start1 Nov 2026 (estimated)
- Primary completion2 Feb 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anahuac University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Juan Antonio Ibarra Arias, Anahuac University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07810517
- Sponsor's protocol ID
- CEI202604
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lactobacillus Acidophilus Combined With Inulin on Cognitive Impairment in Patients With Obesity
- ClinicalTrials.gov ID
- NCT07810517
- Acronym / sponsor ID
- CEI202604
- Conditions
- Obesity (Disorder)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Anahuac UniversityUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 2 Feb 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 9 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Synbiotic - Control | Experimental | Dietary Supplement: Synbiotic (Lactobacillus acidophilus LA-5 and Agave Inulin)Participants will initially receive the synbiotic intervention and subsequently cross over to the control intervention. |
| Control - Synbiotic | Experimental | Dietary Supplement: Synbiotic (Lactobacillus acidophilus LA-5 and Agave Inulin)Participants will initially receive the synbiotic intervention and subsequently cross over to the control intervention. |
Who may qualify
- Ages
- 30 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Synbiotic (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. | Dietary supplement | Control - Synbiotic, Synbiotic - Control |
Primary outcome
Change in Montreal Cognitive Assessment (MoCA) Score
Time frame: 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
Time frame: 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
Time frame: Baseline, Week 12, and Week 26.
The total score ranges from 0 to 50 points, with higher scores indicating better memory performance.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
Related trials for Obesity (Disorder)
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synbiotic (Lactobacillus acidophilus LA-5 and Agave Inulin) in people with Obesity (Disorder), run by Anahuac University at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonio Ibarra, PhD (52 5554197603, jose.ibarra@anahuac.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Montreal Cognitive Assessment (MoCA) Score (time frame: Baseline, Week 12, and Week 26.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.