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

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ClinicalTrials.gov Identifier: NCT04229186
Recruitment Status : Unknown
Verified January 2020 by Maria Trojano, University of Bari Aldo Moro.
Recruitment status was:  Not yet recruiting
First Posted : January 18, 2020
Last Update Posted : January 18, 2020
Sponsor:
Collaborator:
Med & Food and Schena Foundation
Information provided by (Responsible Party):
Maria Trojano, University of Bari Aldo Moro

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.

Condition or disease Intervention/treatment Phase
Neurodegenerative Diseases Dietary Supplement: EVOO-C Dietary Supplement: ROO Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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)
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2022


Arm Intervention/treatment
Experimental: Patients with assumption of EVOO-C
12 patients with Mild Cognitive Impairment or Mild Alzheimer's Disease will receive 10 mg EVOO-C
Dietary Supplement: EVOO-C
Each patient will consume 10 mg total daily amount EVOO-C

Experimental: Patients with assumption of ROO
12 patients with Mild Cognitive Impairment or Mild Alzheimer's Disease will receive 10 mg ROO
Dietary Supplement: ROO
Each patient will consume 10 mg total daily amount ROO




Primary Outcome Measures :
  1. Evaluate the change of cerebral performance after olive oil supplementation. [ Time Frame: Change from baseline MMSE score at 12 months ]
    The change of cerebral performance will be documented by neuropsychological assessement with Minimental State Examination (MMSE) (total score)

  2. Evaluate the change of nutritional parameters after olive oil supplementation [ Time Frame: Change from baseline BMI at 3 months, from baseline BMI at 6 months, from baseline BMI at 12 months ]
    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.

  3. Evaluate the change of neurodegenerative biomarkers after olive oil supplementation. [ Time Frame: Change from baseline neurodegenerative biomarkers at 3 months, from baseline neurodegenerative biomarkerse at 6 months, from baseline neurodegenerative biomarkers at 12 months ]
    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))

  4. Evaluate the change of neurodegenerative biomarkers after olive oil supplementation. [ Time Frame: Change from baseline neurodegenerative biomarkers at 12 months ]
    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))

  5. Evaluate the change of optic nerve and macula thickness after olive oil supplementation. [ Time Frame: Change from baseline optic nerve and macula thickness at 12 months ]
    Ocular computerized tomography will be performed and layer of retinal nerve fiber will be measured (micron)

  6. Evaluate the change of cortical thickness with brain MRI after olive oil supplementation. [ Time Frame: Change from baseline at 12 months ]
    Brain MRI will be performed to assess cortical thickness using Normalized Thickness Index (NTI)

  7. Evaluate the change of brain amyloid plaque load (BAPL) after olive oil supplementation. [ Time Frame: Change from baseline BAPL at 12 months ]
    Beta amyloid positron emission tomography will be performed measuring a index called BAPL.



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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Publications:
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Responsible Party: Maria Trojano, Full Professor, University of Bari Aldo Moro
ClinicalTrials.gov Identifier: NCT04229186    
Other Study ID Numbers: 5752
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maria Trojano, University of Bari Aldo Moro:
Mild Cognitive Impairment
Alzheimer's Disease
Extra Virgin Olive Oil
Additional relevant MeSH terms:
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Alzheimer Disease
Neurodegenerative Diseases
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurocognitive Disorders
Mental Disorders
Cognition Disorders