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NOT YET RECRUITING
NCT06670807
NA

Effect of a Probiotic Formula in Mild Cognitive Impairement

Sponsor: Universidad Complutense de Madrid

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

65 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2025-01

Completion Date

2026-06

Last Updated

2024-11-01

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Probiotic 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.

OTHER

Placebo

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