Pilot Study About Extra Virgin Olive Oil "Coratina" in Mild Cognitive Impairment and Alzheimer's Disease Patients (EVOCAD)
Primary Purpose
Neurodegenerative Diseases
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
EVOO-C
ROO
Sponsored by
About this trial
This is an interventional prevention trial for Neurodegenerative Diseases focused on measuring Mild Cognitive Impairment, Alzheimer's Disease, Extra Virgin Olive Oil
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Patients with assumption of EVOO-C
Patients with assumption of ROO
Arm Description
12 patients with Mild Cognitive Impairment or Mild Alzheimer's Disease will receive 10 mg EVOO-C
12 patients with Mild Cognitive Impairment or Mild Alzheimer's Disease will receive 10 mg ROO
Outcomes
Primary Outcome Measures
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)
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.
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))
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))
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)
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)
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04229186
First Posted
September 23, 2019
Last Updated
January 11, 2020
Sponsor
University of Bari Aldo Moro
Collaborators
Med & Food and Schena Foundation
1. Study Identification
Unique Protocol Identification Number
NCT04229186
Brief Title
Pilot Study About Extra Virgin Olive Oil "Coratina" in Mild Cognitive Impairment and Alzheimer's Disease Patients
Acronym
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)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2020 (Anticipated)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
January 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bari Aldo Moro
Collaborators
Med & Food and Schena Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurodegenerative Diseases
Keywords
Mild Cognitive Impairment, Alzheimer's Disease, Extra Virgin Olive Oil
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with assumption of EVOO-C
Arm Type
Experimental
Arm Description
12 patients with Mild Cognitive Impairment or Mild Alzheimer's Disease will receive 10 mg EVOO-C
Arm Title
Patients with assumption of ROO
Arm Type
Experimental
Arm Description
12 patients with Mild Cognitive Impairment or Mild Alzheimer's Disease will receive 10 mg ROO
Intervention Type
Dietary Supplement
Intervention Name(s)
EVOO-C
Intervention Description
Each patient will consume 10 mg total daily amount EVOO-C
Intervention Type
Dietary Supplement
Intervention Name(s)
ROO
Intervention Description
Each patient will consume 10 mg total daily amount ROO
Primary Outcome Measure Information:
Title
Evaluate the change of cerebral performance after olive oil supplementation.
Description
The change of cerebral performance will be documented by neuropsychological assessement with Minimental State Examination (MMSE) (total score)
Time Frame
Change from baseline MMSE score at 12 months
Title
Evaluate the change of nutritional parameters after olive oil supplementation
Description
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.
Time Frame
Change from baseline BMI at 3 months, from baseline BMI at 6 months, from baseline BMI at 12 months
Title
Evaluate the change of neurodegenerative biomarkers after olive oil supplementation.
Description
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))
Time Frame
Change from baseline neurodegenerative biomarkers at 3 months, from baseline neurodegenerative biomarkerse at 6 months, from baseline neurodegenerative biomarkers at 12 months
Title
Evaluate the change of neurodegenerative biomarkers after olive oil supplementation.
Description
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))
Time Frame
Change from baseline neurodegenerative biomarkers at 12 months
Title
Evaluate the change of optic nerve and macula thickness after olive oil supplementation.
Description
Ocular computerized tomography will be performed and layer of retinal nerve fiber will be measured (micron)
Time Frame
Change from baseline optic nerve and macula thickness at 12 months
Title
Evaluate the change of cortical thickness with brain MRI after olive oil supplementation.
Description
Brain MRI will be performed to assess cortical thickness using Normalized Thickness Index (NTI)
Time Frame
Change from baseline at 12 months
Title
Evaluate the change of brain amyloid plaque load (BAPL) after olive oil supplementation.
Description
Beta amyloid positron emission tomography will be performed measuring a index called BAPL.
Time Frame
Change from baseline BAPL at 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22837695
Citation
Zhao LN, Long HW, Mu Y, Chew LY. The toxicity of amyloid beta oligomers. Int J Mol Sci. 2012;13(6):7303-7327. doi: 10.3390/ijms13067303. Epub 2012 Jun 13.
Results Reference
background
PubMed Identifier
26252902
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.
Results Reference
background
PubMed Identifier
3496763
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.
Results Reference
background
PubMed Identifier
24360540
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.
Results Reference
background
PubMed Identifier
29387532
Citation
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.
Results Reference
background
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Pilot Study About Extra Virgin Olive Oil "Coratina" in Mild Cognitive Impairment and Alzheimer's Disease Patients
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