Effect of Mediterranean Diet and Probiotics in Adults With Mild Cognitive Impairment

Pablo Pérez Martínez

Status: Completed

Conditions: Mild Cognitive Impairment

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Healthy diet (WHO recommendations); Dietary Supplement: Mediterranean diet; Dietary Supplement: Biopolis-MIX42

Study type: Interventional

Funder types: Other

Identifiers

NCT05029765

PI16/01777

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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50 participants in 3 patient groups, including a placebo group

Healthy diet Arm

Placebo Comparator group

Description:

Healthy diet (WHO recommendations) + placebo

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: Healthy diet (WHO recommendations)

Mediterranean diet Arm

Placebo Comparator group

Description:

Mediterranean diet + placebo

Treatment:

Dietary Supplement: Mediterranean diet

Dietary Supplement: Placebo

Mediterranean diet "plus" Arm

Active Comparator group

Description:

Mediterranean diet + Biopolis-MIX42 (1 capsule per day containing 10\^9 colony forming units of Lactobacillus rhamnosus and Bifidobacterium long).

Treatment:

Dietary Supplement: Mediterranean diet

Dietary Supplement: Biopolis-MIX42