NCT06670807 Effect of a Probiotic Formula in Mild Cognitive Impairement

Eligibility & Interventions

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This trial targets 100 participants in total. It began in 2026-03-21 with a primary completion date of 2027-05.

Brief 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 Criteria

Inclusion Criteria: * Men and women aged between 60 and 85 years. * Present "Mild Cognitive Impairment" (MCI) based on: * MoCA test (\< 26 points) or score adjusted for educational level * and CDR test (≤ 0.5 points) * Maintain functional capacity according to the (I)ADL test (≥ 70 points) * Show "cognitive concern" reported by the participant and/or a surrogate caregiver * Demonstrate longitudinal decline in cognitive function (progressive and not stabilized) for more than 3-5 years. * BMI ≥ 20 and \< 30 kg/m² * Absence of a family or social environment that prevents treatment adherence. * Adequate cultural level and understanding of the clinical study. * Agree to participate voluntarily in the study and provide written informed consent. Exclusion Criteria: * Subjects with severe neurological or psychiatric disorders due to any of the following causes: severe dementia, depression, epilepsy, schizophrenia, or bipolar disorder. * Subjects who have suffered a severe stroke prior to the study (FAZKAS=3) * Subjects with a history of malignancy \< 5 years (\< 5 years if the brain was affected) * Subjects who have experienced severe traumatic brain injury with structural brain injury and/or prior brain surgery * Subjects with pacemakers and those with metal implants that may interfere with EEG or MRI * Subjects treated with medications: benzodiazepines, neuroleptics, narcotics, anticonvulsants, or sedative-hypnotics in the last 3 months * Subjects who have been treated with antibiotics or probiotic supplements at least 3 months before the start of the study. * Subjects with hearing or visual impairments that prevent the evaluations included in the study * Subjects with severe illnesses affecting nutritional status (liver, kidney, etc.) * Subjects who have engaged in weight loss diets or significant dietary changes in the 8 weeks prior to starting the study * Subjects with high alcohol consumption (\> 3 alcoholic beverages per day)

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