Clinical trial NCT04229186: Pilot Study About Extra Virgin Olive Oil "Coratina" in Mild Cognitive Impairment and Alzheimer's Disease Patients
Official title: Pilot Study About Extra Virgin Oil "Coratina" (Evoo-c) in Mild Cognitive Impairment (MCI) and Alzheimer's Disease (AD) Patients (EVOO-c in MCI/AD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neurodegenerative Diseases
Keywords: Mild Cognitive Impairment
Alzheimer's Disease
Extra Virgin Olive Oil
Lead sponsor: University of Bari Aldo Moro
Sponsor class: OTHER
Collaborators: name: Med & Food and Schena Foundation
First posted: 2020-01-18
Enrollment: 24
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Evaluate the change of cerebral performance after olive oil supplementation.
timeFrame: Change from baseline MMSE score at 12 months
measure: Evaluate the change of nutritional parameters after olive oil supplementation
timeFrame: Change from baseline BMI at 3 months, from baseline BMI at 6 months, from baseline BMI at 12 months
measure: Evaluate the change of neurodegenerative biomarkers after olive oil supplementation.
timeFrame: Change from baseline neurodegenerative biomarkers at 3 months, from baseline neurodegenerative biomarkerse at 6 months, from baseline neurodegenerative biomarkers at 12 months
measure: Evaluate the change of neurodegenerative biomarkers after olive oil supplementation.
timeFrame: Change from baseline neurodegenerative biomarkers at 12 months
measure: Evaluate the change of optic nerve and macula thickness after olive oil supplementation.
timeFrame: Change from baseline optic nerve and macula thickness at 12 months
measure: Evaluate the change of cortical thickness with brain MRI after olive oil supplementation.
timeFrame: Change from baseline at 12 months
measure: Evaluate the change of brain amyloid plaque load (BAPL) after olive oil supplementation.
timeFrame: Change from baseline BAPL at 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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citation: Fazekas F, Chawluk JB, Alavi A, Hurtig HI, Zimmerman RA. MR signal abnormalities at 1.5 T in Alzheimer's dementia and normal aging. AJR Am J Roentgenol. 1987 Aug;149(2):351-6. doi: 10.2214/ajr.149.2.351.
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