RecruitingNot ApplicableNCT06670807

Effect of a Probiotic Formula in Mild Cognitive Impairement

Clinical Trial to Evaluate the Efficacy of a Probiotic Formula on Cognitive Function in Mild Cognitive Impairement Patients.


Sponsor

Universidad Complutense de Madrid

Enrollment

100 participants

Start Date

Mar 21, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

Mild cognitive impairment is currently one of the most relevant social challenges, as its prevalence is expected to increase and it is associated with a higher risk of developing Alzheimer's disease or other types of dementia. Therefore, it is necessary to seek strategies that can be applied in the early stages to delay or reverse the progression of the disease. In this context, probiotics have emerged as a promising alternative for managing cognitive disorders. This project is a clinical-nutritional trial to evaluate the utility of consuming a dietary supplement containing probiotics on the cognitive function of individuals with mild cognitive impairment. The study will involve 100 participants, selected from the Geriatrics Unit of San Carlos Clinical Hospital, as well as through various Leisure Centers in Madrid, randomly assigned to two groups of 50 individuals each (Experimental Group and Control Group). Participants assigned to the experimental group will consume the dietary supplement, while those in the control group will receive a placebo, which is a product without probiotics. Both groups will take 1 capsule per day of the assigned product at breakfast for 16 weeks. During this time, changes will be analyzed in various imaging tests, cognitive tests, and some blood parameters related to cognitive function. Changes in gut microbiota and different lifestyle factors (diet, body composition, physical activity, sleep) will also be evaluated.


Eligibility

Min Age: 65 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Placebo and Probiotic Arm for people with mild cognitive impairment (mci). The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTProbiotic Arm

Fifty of the participants will consume 1 capsule/day of the dietary supplement AB-MIND+CECT7481 for 16 weeks. The capsule should be taken just before breakfast. The researchers will instruct the volunteers to maintain their usual lifestyle (diet, physical activity, sleep habits) throughout the intervention period.

OTHERPlacebo

Fifty of the participants will consume 1 capsule/day of the PLACEBO for 16 weeks. The capsule should be taken just before breakfast. The researchers will instruct the volunteers to maintain their usual lifestyle (diet, physical activity, sleep habits) throughout the entire intervention period.


Locations(2)

Facultad de Farmacia Universidad Complutense de Madrid (UCM) Plaza Ramón y Cajal

Madrid, Madrid, Spain

Hospital Clínico San Carlos

Madrid, Madrid, Spain

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NCT06670807


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