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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05029765
Other study ID # PI16/01777
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 26, 2017
Est. completion date March 5, 2020

Study information

Verified date August 2021
Source Maimónides Biomedical Research Institute of Córdoba
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date March 5, 2020
Est. primary completion date March 5, 2020
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Mediterranean diet
Mediterranean diet: 22% Monounsaturated fat, 6% Polyunsaturated fat, 7% Saturated fat, 15% Protein, 50% Carbohydrates
Healthy diet (WHO recommendations)
Recommendations according to WHO
Placebo
Placebo
Biopolis-MIX42
Biopolis-MIX42: a capsule containing 10^9 colony forming units of Lactobacillus rhamnosus and Bifidobacterium longum.

Locations

Country Name City State
Spain Reina Sofia University Hospital Cordoba

Sponsors (1)

Lead Sponsor Collaborator
Pablo Pérez Martínez

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cognitive change 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. Baseline and 24 weeks after each dietary intervention
Secondary Microbiota pattern Changes in the percentage of different families of Microbiota will be analysed during the study Baseline and 24 weeks after each dietary intervention
Secondary Endotoxemia levels Changes in the endotoxemia levels will be analysed during the study Baseline and 24 weeks after each dietary intervention
Secondary Change in inflammatory marker At time 0 and after 24 weeks of each intervention period and follow-up, the levels of high sesitivity C-reactive protein (hs-CRP) were determined in plasma in mg/dL. Baseline and 24 weeks after each dietary intervention
Secondary Change in oxidative stress parameters At time 0 and after 24 weeks of each intervention period and follow-up, the levels of advanced glycation end products (AGEs) were determined in serum in ug/mL: methylglioxal (MG) and N-carboxymethyllysine (CML). Likewise, carbonilated proteins in nmol/mg and lipid peroxidation levels in plasma in ug/mL. Baseline and 24 weeks after each dietary intervention
Secondary Neurofunctional change At time 0 and after 24 weeks of each intervention period and follow-up, neurofunctional changes were measured by emission tomography with 2-deoxy-2-[fluorine-18]fluoro- D-glucose (18F-FDG-PET) Baseline and 24 weeks after each dietary intervention
Secondary Modulation of Microbiota-gut-nervous system Changes in the plasma levels of molecules with activity on the nervous system were analysed during the study. At time 0 and after 24 weeks of each intervention period and follow-up, Gamma-Aminobutiric acid (GABA) in ng/mL and short-chain fatty acids (acetate, propionate and butirate) in ng/mL were determined in plasma. Baseline and 24 weeks after each dietary intervention
Secondary Change in cytokine levels At time 0 and after 24 weeks of each intervention period and follow-up, the levels of interleukin-6 (IL-6) and tumor necrosis factor alpha (TNF-a) were determined in plasma in pg/mL. Baseline and 24 weeks after each dietary intervention
Secondary Neuropeptides modulation Changes in the plasma levels of molecules with activity on the nervous system were analysed during the study. At time 0 and after 24 weeks of each intervention period and follow-up, Substance P (SP), Y Peptide (PYY), beta-amyloid in pg/mL were determined in plasma. Baseline and 24 weeks after each dietary intervention
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