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

Extra-virgin Olive Oil Prevents Mild Cognitive Impairment Conversion to Alzheimer's Disease

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

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease; Cerebral Amyloid Angiopathy
• Intervention / Treatment: Other: EVOO; Other: OO

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Auburn, Alabama, United States, 36849
      • Auburn University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 53 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of olive oil on the BBB intactness	Will be evaluated by DCE-MRI	6 months
Effect of olive oil on the brain activity	Will be evaluated by fMRI	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive function	A battery of cognitive tasks to assess memory	6 months

Collaborators and Investigators

• Sponsor: Auburn University
• Investigators: Principal Investigator: Amal Kaddoumi, PhD, Auburn University

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2019
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: January 28, 2019
• First Submitted That Met QC Criteria: January 29, 2019
• First Posted (Actual): January 31, 2019

Study Record Updates

• Last Update Posted (Actual): August 2, 2021
• Last Update Submitted That Met QC Criteria: July 29, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Metabolic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Genetic Diseases, Inborn; Neurodegenerative Diseases; Proteostasis Deficiencies; Metabolism, Inborn Errors; Dementia; Tauopathies; Brain Diseases, Metabolic; Brain Diseases, Metabolic, Inborn; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Cerebral Small Vessel Diseases; Amyloidosis, Familial; Amyloidosis; Alzheimer Disease; Cerebral Amyloid Angiopathy; Cerebral Amyloid Angiopathy, Familial
• Other Study ID Numbers: 18-446 MR 1901

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No