Effect of a Probiotic Formula in Mild Cognitive Impairement

NCT06670807 | Not Yet Recruiting

• 1 other identifier: CPP2022-009632
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Mild Cognitive Impairment (MCI)

Keywords

Mild Cognitive Impairment (MCI); Probiotic; Cognitive function; Microbiota; Nutrition; Elderly

Outcome Measures

Primary Outcomes (1)

• Change in cognitive function by electrophysiological study

  Changes in cognitive function evaluated by studying variations in the functional network through phase hypersynchrony in the alpha band, measured using an electrophysiological study. Functional network of the brain will be recorded using an Electroencephalography (EEG) with 128 channels. 20 minutes of resting state activity will be recorded for each participant: 10 minutes with opened eyes and 10 minutes with closed eyes. The signal will be filtered in-line between 0.1 and 300 Hz, sampled at a sampling rate of 1000 Hz. The recordings will be preprocessed using the spatio-temporal filtering algorithm tSSS (Taulu, 2009) with the software Maxfilter software (supplied by Elekta) to remove magnetic noise and compensate for head movements during the recordings.

  From enrollment to the end of treatment at 16 weeks

Secondary Outcomes (10)

• Change in global cognitive function by MoCA test

  From enrollment to the end of treatment at 16 weeks

• Change in global cognitive function by CDR test

  From enrollment to the end of treatment at 16 weeks

• Change in verbal episodic memory by WMS-III

  From enrollment to the end of treatment at 16 weeks

• Change in verbal fluency by Boston Naming Test

  From enrollment to the end of treatment at 16 weeks

• Change in mood by Geriatric Depression Scale

  From enrollment to the end of treatment at 16 weeks

Study Arms (2)

Experimental group

ACTIVE COMPARATOR

Probiotic formulation that includes L. plantarum CECT 7481, L. plantarum CECT 7485 Y L. brevis CECT7480

Dietary Supplement: Probiotic Arm

Control Group

PLACEBO COMPARATOR

Placebo comparator arm with identical pharmaceutical form and aspect, containing microcrystalline cellulose

Other: Placebo

Interventions

Probiotic Arm DIETARY_SUPPLEMENT

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.

Also known as: AB-MIND+CECT7481

Experimental group

Placebo OTHER

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.

Control Group

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead
• AB Biotics, SA: collaborator

Study Sites (2)

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

Madrid, Madrid, 28040, Spain

Location

Hospital Clínico San Carlos

Madrid, Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

ANA M LÓPEZ SOBALER

CONTACT

+34 913941732; asobaler@ucm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: November 1, 2024
• Study Start: January 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)