NCT03824197: (AU-ROOAD)

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

Completed NA Last updated 2 August 2021

What this trial tests

NA trial testing EVOO in Alzheimer Disease in 25 participants. Completed in 31 December 2020.

Timeline

7 May 2019

Primary endpoint
31 December 2020

31 December 2020

Quick facts

Lead sponsor	Auburn University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	25
Start date	7 May 2019
Primary completion	31 December 2020
Estimated completion	31 December 2020
Sites	1 location across United States

Drugs / interventions tested

• EVOO
• OO

Conditions studied

• Alzheimer Disease — all drugs for Alzheimer Disease →
• Cerebral Amyloid Angiopathy — all drugs for Cerebral Amyloid Angiopathy →

Sponsor

Auburn University

Who can join

Adults 55 to 75, any sex, with Alzheimer Disease or Cerebral Amyloid Angiopathy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Extra-Virgin Olive Oil Enhances the Blood-Brain Barrier Function in Mild Cognitive Impairment: A Randomized Controlled Trial.
   Kaddoumi A, Denney TS, Deshpande G, Robinson JL, et al · · 2022 · cited 49× · PMID 36501136 · DOI 10.3390/nu14235102
2. Polyphenols, the Healthy Brand of Olive Oil: Insights and Perspectives.
   Finicelli M, Squillaro T, Galderisi U, Peluso G. · · 2021 · cited 36× · PMID 34836087 · DOI 10.3390/nu13113831
3. The Role of Natural Antioxidants in the Prevention of Dementia-Where Do We Stand and Future Perspectives.
   Jurcau A. · · 2021 · cited 36× · PMID 33498262 · DOI 10.3390/nu13020282
4. Effect Of An Extra-Virgin Olive Oil Intake On The Delay Of Cognitive Decline: Role Of Secoiridoid Oleuropein?
   Klimova B, Novotný M, Kuca K, Valis M. · · 2019 · cited 17× · PMID 31754302 · DOI 10.2147/ndt.s218238
5. Approaches for Increasing Cerebral Efflux of Amyloid-β in Experimental Systems.
   Loeffler DA. · · 2024 · cited 8× · PMID 38875041 · DOI 10.3233/jad-240212
6. Olive Oil Industry By-Products as a Novel Source of Biophenols with a Promising Role in Alzheimer Disease Prevention.
   Gonçalves M, Costa M, Paiva-Martins F, Silva P. · · 2024 · cited 5× · PMID 39459209 · DOI 10.3390/molecules29204841
7. Enhancing of cerebral Abeta clearance by modulation of ABC transporter expression: a review of experimental approaches.
   Loeffler DA. · · 2024 · cited 2× · PMID 38872626 · DOI 10.3389/fnagi.2024.1368200
8. Natural Products in Alzheimer's Disease: A Systematic Review of Clinical Trials and Underlying Molecular Mechanisms.
   Bayo Jimenez MT, Rivas-García L, Sánchez-González C, Grosso G, et al · · 2025 · PMID 41226670 · DOI 10.3390/ijms262110631