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

January 11, 2020 updated by: Maria Trojano, University of Bari Aldo Moro

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)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Change from baseline MMSE score at 12 months
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.
Change from baseline BMI at 3 months, from baseline BMI at 6 months, from baseline BMI at 12 months
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))
Change from baseline neurodegenerative biomarkers at 3 months, from baseline neurodegenerative biomarkerse at 6 months, from baseline neurodegenerative biomarkers at 12 months
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))
Change from baseline neurodegenerative biomarkers at 12 months
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)
Change from baseline optic nerve and macula thickness at 12 months
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)
Change from baseline at 12 months
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.
Change from baseline BAPL at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bari Aldo Moro

Collaborators

Med & Food and Schena Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2020

Primary Completion (Anticipated)

January 1, 2021

Study Completion (Anticipated)

January 1, 2022

Study Registration Dates

First Submitted

September 23, 2019

First Submitted That Met QC Criteria

January 11, 2020

First Posted (Actual)

January 18, 2020

Study Record Updates

Last Update Posted (Actual)

January 18, 2020

Last Update Submitted That Met QC Criteria

January 11, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5752

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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