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

University of Bari Aldo Moro

Status: Unknown

Conditions: Neurodegenerative Diseases

Treatments: Dietary Supplement: EVOO-C; Dietary Supplement: ROO

Study type: Interventional

Funder types: Other

Identifiers

NCT04229186

5752

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 24 estimated patients

Sex: All

Ages: 50 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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24 participants in 2 patient groups

Patients with assumption of EVOO-C

Experimental group

Description:

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

Treatment:

Dietary Supplement: EVOO-C

Patients with assumption of ROO

Experimental group

Description:

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

Treatment:

Dietary Supplement: ROO