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

Alzheimer Disease Clinical Trial

— (AU-ROOAD)  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03824197
• Other study ID #: 18-446 MR 1901
• Status: Completed
• Phase: N/A
• Start date: May 7, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: July 2021
• Source: Auburn University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Cerebral Amyloid Angiopathy

Intervention

Other:
• EVOO
Extra-virgin olive oil that is rich with oleocanthal and other phenols.
• OO
Olive oil low in oleocanthal and other phenols.

Locations

Country	Name	City	State
United States	Auburn University	Auburn	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
Auburn University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of olive oil on the BBB intactness	Will be evaluated by DCE-MRI	6 months
Primary	Effect of olive oil on the brain activity	Will be evaluated by fMRI	6 months
Secondary	Cognitive function	A battery of cognitive tasks to assess memory	6 months