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

Neurodegenerative Diseases Clinical Trial

— EVOCAD  

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04229186
• Other study ID #: 5752
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2020
• Est. completion date: January 2022

Study information

• Verified date: January 2020
• Source: University of Bari Aldo Moro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: January 2022
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Neurodegenerative Diseases

Intervention

Dietary Supplement:
• EVOO-C
Each patient will consume 10 mg total daily amount EVOO-C
• ROO
Each patient will consume 10 mg total daily amount ROO

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Bari Aldo Moro	Med & Food and Schena Foundation

References & Publications (5)

Caminiti SP, Ballarini T, Sala A, Cerami C, Presotto L, Santangelo R, Fallanca F, Vanoli EG, Gianolli L, Iannaccone S, Magnani G, Perani D; BIOMARKAPD Project. FDG-PET and CSF biomarker accuracy in prediction of conversion to different dementias in a large multicentre MCI cohort. Neuroimage Clin. 2018 Jan 28;18:167-177. doi: 10.1016/j.nicl.2018.01.019. eCollection 2018. — View Citation

Coppola G, Di Renzo A, Ziccardi L, Martelli F, Fadda A, Manni G, Barboni P, Pierelli F, Sadun AA, Parisi V. Optical Coherence Tomography in Alzheimer's Disease: A Meta-Analysis. PLoS One. 2015 Aug 7;10(8):e0134750. doi: 10.1371/journal.pone.0134750. eCollection 2015. — View 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. — View Citation

Jack CR Jr, Holtzman DM. Biomarker modeling of Alzheimer's disease. Neuron. 2013 Dec 18;80(6):1347-58. doi: 10.1016/j.neuron.2013.12.003. Review. — View Citation

Zhao LN, Long H, Mu Y, Chew LY. The toxicity of amyloid ß oligomers. Int J Mol Sci. 2012;13(6):7303-27. doi: 10.3390/ijms13067303. Epub 2012 Jun 13. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the change of cerebral performance after olive oil supplementation.	The change of cerebral performance will be documented by neuropsychological assessement with Minimental State Examination (MMSE) (total score)	Change from baseline MMSE score at 12 months
Primary	Evaluate the change of nutritional parameters after olive oil supplementation	Weight and height will be combined to report BMI in Kg/m^2. Nutritional assessment will be measured comparing the variation of BMI of each patient during the follow up.	Change from baseline BMI at 3 months, from baseline BMI at 6 months, from baseline BMI at 12 months
Primary	Evaluate the change of neurodegenerative biomarkers after olive oil supplementation.	Neurodegenerative biomarkers will be tested with blood samples and with cerebrospinal fluid analisys (cerebrospinal level of Beta-amiloid, Tau and phospotau, BDNF (pg/mL; blood level of BDNF e NFL (pg/mL))	Change from baseline neurodegenerative biomarkers at 3 months, from baseline neurodegenerative biomarkerse at 6 months, from baseline neurodegenerative biomarkers at 12 months
Primary	Evaluate the change of neurodegenerative biomarkers after olive oil supplementation.	Neurodegenerative biomarkers will be tested with blood samples and with cerebrospinal fluid analysis (cerebrospinal level of Beta-amyloid, Tau and phosphotau, BDNF (pg/mL; blood level of BDNF e NFL (pg/mL))	Change from baseline neurodegenerative biomarkers at 12 months
Primary	Evaluate the change of optic nerve and macula thickness after olive oil supplementation.	Ocular computerized tomography will be performed and layer of retinal nerve fiber will be measured (micron)	Change from baseline optic nerve and macula thickness at 12 months
Primary	Evaluate the change of cortical thickness with brain MRI after olive oil supplementation.	Brain MRI will be performed to assess cortical thickness using Normalized Thickness Index (NTI)	Change from baseline at 12 months
Primary	Evaluate the change of brain amyloid plaque load (BAPL) after olive oil supplementation.	Beta amyloid positron emission tomography will be performed measuring a index called BAPL.	Change from baseline BAPL at 12 months