Clinical trial NCT05029765: Effect of Mediterranean Diet and Probiotics in Adults With Mild Cognitive Impairment
Official title: A 24 Weeks Double-blind Latin-square Trial of Effect of Mediterranean Diet and Probiotics in Adults With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Mild Cognitive Impairment
Probiotics
Microbiota
Mediterranean diet
Lead sponsor: Maimónides Biomedical Research Institute of Córdoba
Sponsor class: OTHER
First posted: 2021-09-01
Enrollment: 50
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 50 men and women with mild cognitive impairment and more than 60 years will follow three dietary intervention periods of 24 weeks each, with a randomized crossover design. Dietary periods will be: 1.- Healthy diet (WHO recommendations) + placebo; 2.- Mediterranean diet + placebo and ; 3.- Mediterranean diet "plus" (Mediterranean diet + Biopolis-MIX42 (a capsule containing 10\^9 colony forming units of Lactobacillus rhamnosus and Bifidobacterium longum)).
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Cognitive change
timeFrame: Baseline and 24 weeks after each dietary intervention
Secondary outcomes:
measure: Microbiota pattern
timeFrame: Baseline and 24 weeks after each dietary intervention
measure: Endotoxemia levels
timeFrame: Baseline and 24 weeks after each dietary intervention
measure: Change in inflammatory marker
timeFrame: Baseline and 24 weeks after each dietary intervention
measure: Change in oxidative stress parameters
timeFrame: Baseline and 24 weeks after each dietary intervention
measure: Neurofunctional change
timeFrame: Baseline and 24 weeks after each dietary intervention
measure: Modulation of Microbiota-gut-nervous system
timeFrame: Baseline and 24 weeks after each dietary intervention
measure: Change in cytokine levels
timeFrame: Baseline and 24 weeks after each dietary intervention
measure: Neuropeptides modulation
timeFrame: Baseline and 24 weeks after each dietary intervention
Other outcomes:
Locations:
city: Cordoba
country: Spain
facility: Reina Sofia University Hospital
Study officials:
affiliation: IMIBIC/ Reina Sofia University Hospital / University of Cordoba
name: Pablo Perez-Martinez, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: