Effect of a Probiotic Formula in Mild Cognitive Impairement
ConditionMild Cognitive Impairment (MCI)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-85
SponsorUniversidad Complutense de Madrid
About this trial
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
This trial does not accept healthy volunteersQualifiers
Men and women aged between 60 and 85 years.
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Probiotic Arm
Dietary supplementFifty 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.
Placebo
Other interventionFifty 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Experimental groupActive comparator 1 intervention
Group B: Control GroupPlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
From enrollment to the end of treatment at 16 weeksSecondary outcomes
1
Change in global cognitive function by MoCA test
Changes in global cognitive function will be analyzed by Montreal Cognitive Assessment test (MoCA) before the intervention, and at the end of the treatment at 16 weeks. The score range of MoCA is 0-30.
Time frame
From enrollment to the end of treatment at 16 weeks2
Change in global cognitive function by CDR test
Changes in global cognitive function will be analyzed by Clinical Dementia Rating (CDR) before the intervention, and at the end of the treatment at 16 weeks. The CDR is based on a scale of 0-3: no dementia (CDR = 0), questionable dementia (CDR = 0.5), MCI (CDR = 1), moderate cognitive impairment (CDR = 2), and severe cognitive impairment (CDR = 3).
Time frame
From enrollment to the end of treatment at 16 weeks3
Change in verbal episodic memory by WMS-III
Changes in verbal episodic memory will be analyzed by Wechsler Memory Scale 3rd edition (WMS-III) before the intervention, and at the end of the treatment at 16 weeks. The WMS-III has most representative standardization databases to assess memory and make optimal clinical recommendations. The 11 subtests that comprise the index scores average 60 min, ranging from 45 to 75 min, to administer. The time needed to administer the 13 subtests required to generate all of the summary and index scores is 80 min, with a range of 65 to 95 min.
Time frame
From enrollment to the end of treatment at 16 weeks4
Change in verbal fluency by Boston Naming Test
Changes in verbal fluecy will be analyzed by Boston Naming Test (BNT) before the intervention, and at the end of the treatment at 16 weeks. BNT measures word retrieval. The range is 0-60 with higher representing better performance.
Time frame
From enrollment to the end of treatment at 16 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Universidad Complutense de Madrid
Lead sponsor
AB Biotics, SA
Collaborator
Source ClinicalTrials.gov