Back to resultsAuburn University Research on Olive Oil for Alzheimer's Disease (AU-ROOAD) ((AU-ROOAD))
Primary Purpose
Alzheimer Disease, Cerebral Amyloid Angiopathy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EVOO
OO
Sponsored by
About this trial
This is an interventional prevention trial for Alzheimer Disease
Eligibility Criteria
Inclusion Criteria:
Men and women, experiencing mild cognitive impairment with:
- Mini-Mental State Exam (MMSE) scores between 18-30 (based on education level
- memory complaint, have objective memory loss measured by education adjusted scores on Wechsler Memory Scale Logical Memory VI
- Clinical Dementia Rating (CDR) score 0.5.
Exclusion Criteria:
- 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.
- Subjects will be excluded if they are smokers
- Subjects who have have clinically important medical or neuropsychiatric comorbidity.
- Subjects who have renal problems or are allergic to the MRI contrast agent.
Sites / Locations
- Auburn University
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
EVOO-phenol high
OO-phenol low
Arm Description
Extra-virgin olive oil rich with oleocanthal and other phenolic compounds that will be added to daily diet
Olive oil with low phenolic content that will be added to daily diet
Outcomes
Primary Outcome Measures
Effect of olive oil on the BBB intactness
Will be evaluated by DCE-MRI
Effect of olive oil on the brain activity
Will be evaluated by fMRI
Secondary Outcome Measures
Cognitive function
A battery of cognitive tasks to assess memory
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03824197
Brief Title
Auburn University Research on Olive Oil for Alzheimer's Disease (AU-ROOAD)
Acronym
(AU-ROOAD)
Official Title
Extra-virgin Olive Oil Prevents Mild Cognitive Impairment Conversion to Alzheimer's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
May 7, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Auburn University
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
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:
Evaluate effect of EVOO on the brain function by functional MRI (fMRI) imaging, and BBB function by dynamic contrast-enhanced MRI (DCE-MRI).
Evaluate effect of EVOO on cognitive function and on selected biomarkers
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Cerebral Amyloid Angiopathy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EVOO-phenol high
Arm Type
Other
Arm Description
Extra-virgin olive oil rich with oleocanthal and other phenolic compounds that will be added to daily diet
Arm Title
OO-phenol low
Arm Type
Other
Arm Description
Olive oil with low phenolic content that will be added to daily diet
Intervention Type
Other
Intervention Name(s)
EVOO
Other Intervention Name(s)
OC-rich EVOO
Intervention Description
Extra-virgin olive oil that is rich with oleocanthal and other phenols.
Intervention Type
Other
Intervention Name(s)
OO
Other Intervention Name(s)
Olive oil
Intervention Description
Olive oil low in oleocanthal and other phenols.
Primary Outcome Measure Information:
Title
Effect of olive oil on the BBB intactness
Description
Will be evaluated by DCE-MRI
Time Frame
6 months
Title
Effect of olive oil on the brain activity
Description
Will be evaluated by fMRI
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Cognitive function
Description
A battery of cognitive tasks to assess memory
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men and women, experiencing mild cognitive impairment with:
Mini-Mental State Exam (MMSE) scores between 18-30 (based on education level
memory complaint, have objective memory loss measured by education adjusted scores on Wechsler Memory Scale Logical Memory VI
Clinical Dementia Rating (CDR) score 0.5.
Exclusion Criteria:
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.
Subjects will be excluded if they are smokers
Subjects who have have clinically important medical or neuropsychiatric comorbidity.
Subjects who have renal problems or are allergic to the MRI contrast agent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amal Kaddoumi, PhD
Organizational Affiliation
Auburn University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Auburn University
City
Auburn
State/Province
Alabama
ZIP/Postal Code
36849
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Auburn University Research on Olive Oil for Alzheimer's Disease (AU-ROOAD)
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