Effect of Mediterranean Diet and Probiotics in Adults With Mild Cognitive Impairment
NCT ID: NCT05029765
Last Updated: 2021-09-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2017-01-26
2020-03-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Healthy diet Arm
Healthy diet (WHO recommendations) + placebo
Healthy diet (WHO recommendations)
Recommendations according to WHO
Placebo
Placebo
Mediterranean diet Arm
Mediterranean diet + placebo
Mediterranean diet
Mediterranean diet:
22% Monounsaturated fat, 6% Polyunsaturated fat, 7% Saturated fat, 15% Protein, 50% Carbohydrates
Placebo
Placebo
Mediterranean diet "plus" Arm
Mediterranean diet + Biopolis-MIX42 (1 capsule per day containing 10\^9 colony forming units of Lactobacillus rhamnosus and Bifidobacterium long).
Mediterranean diet
Mediterranean diet:
22% Monounsaturated fat, 6% Polyunsaturated fat, 7% Saturated fat, 15% Protein, 50% Carbohydrates
Biopolis-MIX42
Biopolis-MIX42: a capsule containing 10\^9 colony forming units of Lactobacillus rhamnosus and Bifidobacterium longum.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
60 Years
ALL
No
Sponsors
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Pablo Pérez Martínez
OTHER
Responsible Party
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Pablo Pérez Martínez
Investigator-in-charge at Nutrigenomics Metabolic Syndrome group
Principal Investigators
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Pablo Perez-Martinez, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
IMIBIC/ Reina Sofia University Hospital / University of Cordoba
Locations
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Reina Sofia University Hospital
Córdoba, , Spain
Countries
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References
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Cardelo MP, Corina A, Leon-Acuna A, Quintana-Navarro GM, Alcala-Diaz JF, Rangel-Zuniga OA, Camargo A, Conde-Gavilan C, Carmona-Medialdea C, Vallejo-Casas JA, Carmona-Asenjo E, Ochoa-Sepulveda JJ, Aguera-Morales E, Delgado-Lista J, Katsiki N, Lopez-Miranda J, Perez-Jimenez F, Yubero-Serrano EM, Perez-Martinez P. Effect of the Mediterranean diet and probiotic supplementation in the management of mild cognitive impairment: Rationale, methods, and baseline characteristics. Front Nutr. 2022 Dec 8;9:1037842. doi: 10.3389/fnut.2022.1037842. eCollection 2022.
Other Identifiers
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PI16/01777
Identifier Type: -
Identifier Source: org_study_id
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