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NCT Number: NCT07741773

Assessing Treatment With High-phenolic EVOO Supplements for Neurovascular Activity

The goal of this clinical trial is to determine whether the extra-virgin olive oil (EVOO) phenolic dietary supplement can improve memory function and modulate biomarkers among individuals with mild cognitive impairment (MCI). The main questions it aims to answer are:

* Does dietary supplementation with EVOO phenolics improve cognitive function? * What would be the effect of the EVOO dietary supplement on other MCI-related biomarkers, including vascular function and biological pathways?

Researchers will compare the EVOO dietary supplements with a placebo (a look-alike substance that contains no EVOO phenolics)

Participants will:

* Take EVOO dietary supplements or a placebo daily for 6 months * Visit the study site during the 6-month study for screening and testing.

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Key information

Conditions

Mild Cognitive Impairment (MCI) Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • CDR (Clinical Dementia Rating) score of 0.5 OR MoCA (Montreal Cognitive Assessment) score of 18-25.

Exclusion criteria

  • History or presence of vascular disease that may affect cognitive function
  • History or presence of stroke within the past 1 year
  • Recent transient ischemic attack (TIA) within the past 180 days
  • History of severe, clinically significant CNS trauma
  • History of intracranial tumor
  • History or presence of kidney disease (eGFR <60 mL/min/1.73m2)
  • Presence of a pacemaker
  • Presence of metal in the body
  • Allergic to the MRI contrast agent "Multihance"
  • Pregnancy

Treatment and study plan

EVOO-phenolics dietary supplement

Dietary Supplement

EVOO phenolic dietary supplement which is standardized to contain10 mg of EVOO total phenolics

Placebo

Dietary Supplement

Placebo

Primary outcomes

  1. Cerebrovascular function

    Time frame: At baseline and end of treatment (6 months)

    To assess the effect of extra virgin olive oil (EVOO) phenolic dietary supplements on blood barin barrier function using Dynamic Contrast-Enhanced MRI (DCE-MRI)

  2. Cerebrovascular blood flow

    Time frame: At baseline and end of treament (6 months)

    To assess the effect of extra virgin olive oil (EVOO) phenolic dietary supplements on cerebrovascular blood flow using Near Infrared Spectroscopy.

  3. Cognitive function

    Time frame: At baseline and end of treament (6 months)

    To assess the effect of extra virgin olive oil (EVOO) phenolic dietary supplements on cognitive function, the Clinical Dementia Rating (CDR) and the National Institutes of Health (NIH) Toolbox Cognition Battery will be used. CDR and NIH Toolbox cognitive tests will be combined to report the overall effect of the intervention on changes in cognitive function. A CDR score of 0.5 indicates mild cognitive impairment, and a score of 3 indicates dementia. Those with a CDR score of 0 indicate normal cognitive function. For the NIH Toolbox tests, the Total Cognition Composite score is used, with 70 or lower indicating impaired cognition and 130 and above indicating superior cognitive ability.

Secondary outcomes

  1. Blood biomarkers

    Time frame: At baseline and end of treatmnet (6 months)

    Assess concentrations of Aβ40, Aβ42, tau, and p-tau181 using highly sensitive commercially available ELISA kits. All these biomarkers will be assessed in concentration units of ng/ml, where their decrease could indicate efficacy.

  2. Proteomics

    Time frame: At baseline and end of treatmnet (6 months)

    To assess the effect of extra virgin olive oil (EVOO) phenolic dietary supplements on changes in blood proteins linked to pathways associated with Alzheimer's disease.

  3. Metabolomics

    Time frame: At baseline and end of treatment (6 months)

    To assess the effect of extra virgin olive oil (EVOO) phenolic dietary supplements on changes in blood metabolites and lipids linked to pathways associated with Alzheimer's disease.

Study contacts

Contact information is provided by the study sponsor or research team.

Amal Kaddoumi, PhD

CONTACT

[email protected]

7067234439

Ryan Harris, PhD

CONTACT

[email protected]

706.721.5998

Sponsors and collaborators

Lead sponsor

Augusta University

Other

Registry information

Official study title

Dietary Supplementation With EVOO Phenolics Prevents MCI Progression to Alzheimer's Disease

Acronym: ATHENA

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 3, 2026
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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