Pilot Study About Extra Virgin Olive Oil "Coratina" in Mild Cognitive Impairment and Alzheimer's Disease Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-31

Study Completion Date

2022-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Alzheimer's Disease is a neurodegenerative disease age related caused by neurofibrillary tangles misfolding and Beta-amyloid protein accumulation. In the last decade several findings showed the role of biophenols present in diary intake such as extra virgin olive oil as potential antagonist of neurodegeneration. Two population studies (The Seven Countries Study and Three-City-Study) and four clinical trials (PREDIMED, PREDIMED - NAVARRA, ACTRIN and ISRCTN) have already suggested that mediterranean diet or other diets supplemented with extra virgin olive oil could improve cerebral performance.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Attenuation of Inflammatory Processes Associated With Alzheimer's Disease After Consumption of Pomace Olive Oil.

NCT04559828

Alzheimer Disease

COMPLETED NA

Study to Evaluate the Effect of a Vegetal Oil on Cognitive Impairment

NCT02778581

Cognitive Impairments Alzheimer Disease

UNKNOWN NA

Study to Evaluate Coconut Oil for Alzheimer's Disease

NCT01883648

Alzheimer's Disease

TERMINATED PHASE2/PHASE3

Management of Mild Cognitive Impairment Patients With Extra Virgin Olive Oil - MICOIL

NCT03362996

Mild Cognitive Impairment

UNKNOWN PHASE2

Does EVOO Induce Gene and Metabolic Changes in Healthy Subjects

NCT05929924

Alzheimer Disease

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

24 MCI or Alzheimer's Disease patients will be recruited and randomised; 12 of them will receive extra virgin olive oil "coratina" (EVOO-C); 12 of them will receive biophenol low dose olive oil (ROO). Each patient will consume a total amount of 10 mg olive oil in a year (12 months). Clinical assessement will be based on:

* neurological examination (T0, T6, T12);
* cardiological examination (T0, T12): a supra-aortic vessels and brachial artery ecocolordoppler will be performed;
* ophthalmological evaluation (T0, T12): a optic coherence tomography will be performed;
* neuropsychological assessment (T0, T12);
* nutritional assessement(T0, T3, T6, T9, T12).

Each subject will perform:

* brain MRI (T0, T12);
* Beta Amyloid Positron Emission Tomography (T0, T12) A lumbar puncture will be ruled as well (T0) and markers of neurodegeneration (Beta-amyloid 1 - 42, total tau protein, fosfo-tau, Brain Derived Neurotrophic Factor (BDNF), Neurofilament (NFL) will be quantified); Renal, hepatic and nutritional status will be assessed 3 times in 12 months (T0, T6, T12).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neurodegenerative Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with assumption of EVOO-C

12 patients with Mild Cognitive Impairment or Mild Alzheimer's Disease will receive 10 mg EVOO-C

Group Type EXPERIMENTAL

EVOO-C

Intervention Type DIETARY_SUPPLEMENT

Each patient will consume 10 mg total daily amount EVOO-C

Patients with assumption of ROO

12 patients with Mild Cognitive Impairment or Mild Alzheimer's Disease will receive 10 mg ROO

Group Type EXPERIMENTAL

ROO

Intervention Type DIETARY_SUPPLEMENT

Each patient will consume 10 mg total daily amount ROO

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

EVOO-C

Each patient will consume 10 mg total daily amount EVOO-C

Intervention Type DIETARY_SUPPLEMENT

ROO

Each patient will consume 10 mg total daily amount ROO

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* MCI diagnosis in the last month prior the recruitment;
* Clinical Dementia Rating Scale - Global Score (CDR - GS) 0,5 and Mini Mental Examination 24 - 27;

Exclusion Criteria

* smoke;
* hypertension;
* diabetes;
* positive history of stroke, epilepsy or cardiac disease;
* BMI \> 30;
* depression or other psychiatric disturbances;
* low compliance to medical interventions;
* positive history of olive oil allergy or intolerance;
* positive history of chronic inflammatory intestinal disease or malabsorption;
* positive history of maculopathy or retinopathy;
* MRI leukoaraiosis II-III grade Fazekas or MRI lacunar infarctions

Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No