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

Auburn University

Status: Completed

Conditions: Alzheimer Disease; Cerebral Amyloid Angiopathy

Treatments: Other: EVOO; Other: OO

Study type: Interventional

Funder types: Other

Identifiers

NCT03824197

18-446 MR 1901

Details and patient eligibility

About

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

Enrollment: 25 patients

Sex: All

Ages: 55 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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25 participants in 2 patient groups

EVOO-phenol high

Other group

Description:

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

Treatment:

Other: EVOO

OO-phenol low

Other group

Description:

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

Treatment:

Other: OO