A 24 Weeks Double-blind Latin-square Trial of Effect of Mediterranean Diet and Probiotics in Adults With Mild Cognitive Impairment

Pablo Pérez Martínez1 site in 1 country50 target enrollmentJanuary 26, 2017

ConditionsMild Cognitive Impairment

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Mild Cognitive Impairment
Sponsor: Pablo Pérez Martínez
Enrollment: 50
Locations: 1
Primary Endpoint: Cognitive change
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Manipulation of the gut microbiota through dietary modification affects brain function, with improvement in patients with cognitive disorders. Combined effect of nutritional intervention with Mediterranean diet and probiotics with potentially healthy growth of germ, affect the evolution of mild cognitive impairment, by the modulation of components related with the axis microbiota-gut-brain: neuropeptides, short-chain fatty acids, markers for oxidative stress and inflammation.

Registry

clinicaltrials.gov

Start Date

January 26, 2017

End Date

March 5, 2020

Last Updated

4 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Pablo Pérez Martínez

Responsible Party

Sponsor Investigator

Principal Investigator

Pablo Pérez Martínez

Investigator-in-charge at Nutrigenomics Metabolic Syndrome group

Maimónides Biomedical Research Institute of Córdoba

Eligibility Criteria

Inclusion Criteria

•Age\> = 60 years with mild cognitive impairment (Clinical Dementia Rating (CRD) 0.5; Mini Mental Examiantion de Folstein (MMSE)\> 23; Repeatable Battery for the Asessment of Neuropsychological Status (RBANS) \<= 85)
•Drugs with a stable dose from a minimum of 4 weeks prior to screening (excluding psychopharmaceuticals and any other that could affect alertness and cognitive ability)
•Geriatric depression scale score \<6
•Sufficient visual and auditory abilities to carry out the neuropsychological tests. Good health without diseases that prevent the completion of the study.
•A minimum educational training established for 6 years or similar work history.
•A familiar informant or close caregiver with a minimum contact with the patient established in 10 hours per week that can accompany the participant to the clinical visits

Exclusion Criteria

•Any uncontrolled medical or neurological condition that, in the opinion of the researcher, could contribute to the subject's cognitive impairment (for example, substances abuse, vitamin B12 deficiency, abnormal thyroid function, stroke, or other Cerebral vascular disease, Lewy body dementia, frontotemporal dementia, TBI).
•A clinically significant psychiatric illness (eg, major depression, schizophrenia, or bipolar affective disorder) in the 6 months prior to screening.
•Transient ischemic attack or cerebrovascular accident or any unexplained loss of consciousness in 1 year before selection (in case of vascular deficit with cognitive sequelae that may still be reversible).
•Poorly controlled diabetes mellitus, due to a glycosylated haemoglobin (HbA1c) value of 8% in the selection.
•History of unstable angina, myocardial infarction, chronic heart failure (New York Heart Association Class 3 or 4), or clinically significant conduction disorders (unstable atrial fibrillation) within 1 year prior to screening.
•Uncontrolled hypertension defined as the mean of 3 measures of systolic blood pressure / diastolic blood pressure\> 165/100 mmHg, and persistent systolic blood pressure / diastolic blood pressure \> 180/100 mmHg in the 3 months prior to randomization which were considered by the researcher as an indicative of chronic uncontrolled hypertension.
•History of seizures in the 10 years prior the selection.
•Recent history (within 1 year of screening) of alcohol or substance abuse with positive urine test (looking for non-prescription drugs), alcohol or cannabinoids.
•Patients with chronic diseases will be excluded: severe psychiatric, chronic processes in need of treatment such as chronic kidney failure, chronic liver disease, neoplasms under treatment, chronic obstructive pulmonary disease, endocrinopathies susceptible to decompensation and digestive tract diseases.

Outcomes

Primary Outcomes

Cognitive change

Time Frame: Baseline and 24 weeks after each dietary intervention

Cognitive change in Alzheimer's Disease Assessment Scale-Cognitive-Plus ("ADAS-Cog- Plus"). The total ADAS-Cog-plus score ranges from 0-70 with higher scores suggesting greater impairment.

Secondary Outcomes

Change in inflammatory marker(Baseline and 24 weeks after each dietary intervention)
Change in oxidative stress parameters(Baseline and 24 weeks after each dietary intervention)
Change in cytokine levels(Baseline and 24 weeks after each dietary intervention)
Microbiota pattern(Baseline and 24 weeks after each dietary intervention)
Endotoxemia levels(Baseline and 24 weeks after each dietary intervention)
Neurofunctional change(Baseline and 24 weeks after each dietary intervention)
Modulation of Microbiota-gut-nervous system(Baseline and 24 weeks after each dietary intervention)
Neuropeptides modulation(Baseline and 24 weeks after each dietary intervention)