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

Not Applicable

Completed

• Conditions: Alzheimer Disease; Cerebral Amyloid Angiopathy
• Interventions: Other: EVOO; Other: OO

• Registration Number: NCT03824197
• Lead Sponsor: Auburn University

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-28
• Study First Submitted QC: 2019-01-29
• Study First Posted: 2019-01-31
• Study Start: 2019-05-07
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-29
• Last Update Posted: 2021-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EVOO-phenol high	EVOO	Extra-virgin olive oil rich with oleocanthal and other phenolic compounds that will be added to daily diet
OO-phenol low	OO	Olive oil with low phenolic content that will be added to daily diet

Primary Outcome Measures

Name	Time	Method
Effect of olive oil on the BBB intactness	6 months	Will be evaluated by DCE-MRI
Effect of olive oil on the brain activity	6 months	Will be evaluated by fMRI

Secondary Outcome Measures

Name	Time	Method
Cognitive function	6 months	A battery of cognitive tasks to assess memory

Trial Locations

Locations (1)

Auburn University; 🇺🇸 Auburn, Alabama, United States