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

NCT05029765 | Completed

• 1 other identifier: PI16/01777
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment

Keywords

Mild Cognitive Impairment; Probiotics; Microbiota; Mediterranean diet

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Microbiota pattern

  Baseline and 24 weeks after each dietary intervention

• Endotoxemia levels

  Baseline and 24 weeks after each dietary intervention

• 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

• Neurofunctional change

  Baseline and 24 weeks after each dietary intervention

Study Arms (3)

Healthy diet Arm

PLACEBO COMPARATOR

Healthy diet (WHO recommendations) + placebo

Dietary Supplement: Healthy diet (WHO recommendations); Dietary Supplement: Placebo

Mediterranean diet Arm

PLACEBO COMPARATOR

Mediterranean diet + placebo

Dietary Supplement: Mediterranean diet; Dietary Supplement: Placebo

Mediterranean diet "plus" Arm

ACTIVE COMPARATOR

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

Dietary Supplement: Mediterranean diet; Dietary Supplement: Biopolis-MIX42

Interventions

Mediterranean diet DIETARY_SUPPLEMENT

Mediterranean diet: 22% Monounsaturated fat, 6% Polyunsaturated fat, 7% Saturated fat, 15% Protein, 50% Carbohydrates

Mediterranean diet "plus" Arm; Mediterranean diet Arm

Healthy diet (WHO recommendations) DIETARY_SUPPLEMENT

Recommendations according to WHO

Healthy diet Arm

Placebo DIETARY_SUPPLEMENT

Placebo

Healthy diet Arm; Mediterranean diet Arm

Biopolis-MIX42 DIETARY_SUPPLEMENT

Biopolis-MIX42: a capsule containing 10\^9 colony forming units of Lactobacillus rhamnosus and Bifidobacterium longum.

Mediterranean diet "plus" Arm

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pablo Pérez Martínez: lead

Study Sites (1)

Reina Sofia University Hospital

Córdoba, Spain

Location

Related Publications (1)

• 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.

  PMID: 36570150 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Diet, Mediterranean; Diet, Healthy

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Pablo Perez-Martinez, PhD, MD

  IMIBIC/ Reina Sofia University Hospital / University of Cordoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Investigator-in-charge at Nutrigenomics Metabolic Syndrome group

Model Details: 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)).

Study Record Dates

• First Submitted: June 14, 2018
• First Posted: September 1, 2021
• Study Start: January 26, 2017
• Primary Completion: March 5, 2020
• Study Completion: March 5, 2020
• Last Updated: September 1, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)