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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-07

Study Completion Date

2020-12-31

Brief Summary

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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

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Detailed Description

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Conditions

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Alzheimer Disease Cerebral Amyloid Angiopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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EVOO-phenol high

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

Group Type OTHER

EVOO

Intervention Type OTHER

Extra-virgin olive oil that is rich with oleocanthal and other phenols.

OO-phenol low

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

Group Type OTHER

OO

Intervention Type OTHER

Olive oil low in oleocanthal and other phenols.

Interventions

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EVOO

Extra-virgin olive oil that is rich with oleocanthal and other phenols.

Intervention Type OTHER

OO

Olive oil low in oleocanthal and other phenols.

Intervention Type OTHER

Other Intervention Names

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OC-rich EVOO Olive oil

Eligibility Criteria

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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.

Minimum Eligible Age

55 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No