MedTrace Logo

Effect of a Probiotic Formula in Mild Cognitive Impairement

NCT06670807 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-11-01

No results posted yet for this study

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.

Conditions

  • Mild Cognitive Impairment (MCI)

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.

Sponsors & Collaborators

  • AB Biotics, SA

    collaborator INDUSTRY

  • Universidad Complutense de Madrid

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-31
Primary Completion
2026-05-31
Completion
2026-06-30

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06670807 on ClinicalTrials.gov