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Auburn University Research on Olive Oil for Alzheimer's Disease (AU-ROOAD)

Sponsor
Auburn University (Other)
Overall Status
Completed
CT.gov ID
NCT03824197
Collaborator
(none)
25
Enrollment
1
Location
2
Arms
19.8
Actual Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Until now there is no medical treatment and/or intervention that can slow, stop or reverse the underlying neurodegenerative of Alzheimer's disease (AD). The goal of this study is to demonstrate "Oleocanthal rich-extra-virgin olive oil (EVOO) consumption stops or delay mild cognitive impairment conversion to AD by restoring the blood-brain barrier (BBB) function in humans".

Specific Aims:

  1. Evaluate effect of EVOO on the brain function by functional MRI (fMRI) imaging, and BBB function by dynamic contrast-enhanced MRI (DCE-MRI).

  2. Evaluate effect of EVOO on cognitive function and on selected biomarkers

Condition or Disease Intervention/Treatment Phase
  • Other: EVOO
  • Other: OO
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Prevention
Official Title:
Extra-virgin Olive Oil Prevents Mild Cognitive Impairment Conversion to Alzheimer's Disease
Actual Study Start Date :
May 7, 2019
Actual Primary Completion Date :
Dec 31, 2020
Actual Study Completion Date :
Dec 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Other: EVOO-phenol high

Extra-virgin olive oil rich with oleocanthal and other phenolic compounds that will be added to daily diet

Other: EVOO
Extra-virgin olive oil that is rich with oleocanthal and other phenols.
Other Names:
  • OC-rich EVOO

    		•
    Other: OO-phenol low

    Olive oil with low phenolic content that will be added to daily diet

    Other: OO
    Olive oil low in oleocanthal and other phenols.
    Other Names:
  • Olive oil

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Effect of olive oil on the BBB intactness [6 months]

      Will be evaluated by DCE-MRI

    2. Effect of olive oil on the brain activity [6 months]

      Will be evaluated by fMRI

    Secondary Outcome Measures

    1. Cognitive function [6 months]

      A battery of cognitive tasks to assess memory

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    Men and women, experiencing mild cognitive impairment with:

    1. Mini-Mental State Exam (MMSE) scores between 18-30 (based on education level

    2. memory complaint, have objective memory loss measured by education adjusted scores on Wechsler Memory Scale Logical Memory VI

    3. Clinical Dementia Rating (CDR) score 0.5.

    Exclusion Criteria:

    1. Subjects with contradictions for MRI include: the presence of metal or electronic devices such as metallic joint prostheses, artificial heart valves, an implantable heart defibrillator, a pacemaker, metal clips, cochlear implants, a bullet, shrapnel or any other type of metal fragment; breathing problems or disorders, claustrophobia, inner ear disorders, vertigo or dizziness, tattoos or permanent makeup that contains metal, and body piercing jewelry that cannot be removed.

    2. Subjects will be excluded if they are smokers

    3. Subjects who have have clinically important medical or neuropsychiatric comorbidity.

    4. Subjects who have renal problems or are allergic to the MRI contrast agent.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Auburn University Auburn Alabama United States 36849

    Sponsors and Collaborators

    • Auburn University

    Investigators

    • Principal Investigator: Amal Kaddoumi, PhD, Auburn University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Amal Kaddoumi, Professor, Auburn University
    ClinicalTrials.gov Identifier:
    NCT03824197
    Other Study ID Numbers:
    • 18-446 MR 1901
    First Posted:
    Jan 31, 2019
    Last Update Posted:
    Aug 2, 2021
    Last Verified:
    Jul 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Alzheimer Disease
    Cerebral Amyloid Angiopathy
    Cerebral Amyloid Angiopathy, Familial

    Study Results

    No Results Posted as of Aug 2, 2021