NCT07741773

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
24mo left

Started Sep 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 3, 2026

Completed
29 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2028

Last Updated

August 3, 2026

Status Verified

June 1, 2026

Enrollment Period

2 years

First QC Date

July 22, 2026

Last Update Submit

July 27, 2026

Conditions

Mild Cognitive Impairment (MCI)

Keywords

Olive oilCognitive functionCerebrovascular functionMCI

Outcome Measures

Primary Outcomes (3)

  • Cerebrovascular function

    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)

    At baseline and end of treatment (6 months)

  • Cerebrovascular blood flow

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

    At baseline and end of treament (6 months)

  • Cognitive function

    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.

    At baseline and end of treament (6 months)

Secondary Outcomes (3)

  • Blood biomarkers

    At baseline and end of treatmnet (6 months)

  • Proteomics

    At baseline and end of treatmnet (6 months)

  • Metabolomics

    At baseline and end of treatment (6 months)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

a look-alike tablet to the intervention that contains no EVOO-phenolics

Dietary Supplement: Placebo

EVOO phenolics

ACTIVE COMPARATOR

EVOO phenolics

Dietary Supplement: EVOO-phenolics dietary supplement

Interventions

EVOO-phenolics dietary supplementDIETARY_SUPPLEMENT

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

EVOO phenolics
PlaceboDIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georgia prevention institute

Augusta, Georgia, 30912, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Amal Kaddoumi, PhD

    Augusta University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amal Kaddoumi, PhD

CONTACT

7067234439akaddoumi@augusta.edu

Ryan Harris, PhD

CONTACT

706.721.5998akaddoumi@augusta.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2026

First Posted

August 3, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

August 31, 2028

Last Updated

August 3, 2026

Record last verified: 2026-06

Locations

US(1)