NCT04229186

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

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)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: University of Bari Aldo Moro · Academic / Other
• Sex: All
• Age: 50 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Neurodegenerative Diseases

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	EVOO-C	Each patient will consume 10 mg total daily amount EVOO-C
DIETARY_SUPPLEMENT	ROO	Each patient will consume 10 mg total daily amount ROO

Timeline

• Start date: 2020-01-01
• Primary completion: 2021-01-01
• Completion: 2022-01-01
• First posted: 2020-01-18
• Last updated: 2020-01-18