Clinical Trial

Does EVOO Induce Gene and Metabolic Changes in Healthy Subjects

Active, Not Recruiting
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Record status
This record was last updated April 20, 2025 (before its estimated July 1, 2025 completion). Its status may not reflect the trial's current state.
Summary
Investigators' recent findings from the pilot clinical trial in MCI individuals demonstrated EVOO improved vascular function and memory. Yet, up to date, whether EVOO protects against AD in individuals with a family history of AD is unknown. Thus, in this study, the investigators will recruit healthy individuals with a family history of AD for participation. From eligible participants, blood samples for ApoE genotyping will be collected, followed by metabolomics, lipidomics, and transcriptomics analyses at baseline. Participants will be randomized into 2 groups (n=20 each); one group will receive EVOO daily (\~2 tablespoons, 30 ml) for 6 months, and the second group will not receive olive oil. Both group participants will receive educational information on brain health and how environmental factors such as lifestyle, diet, and exercise could impact brain health. After 6 months, another blood sample will be collected from the participants to evaluate the effect of EVOO on metabolites, lipids, and genes, and thus physiological pathways. The investigators will perform non-targeted and comprehensive metabolomics, lipidomics, and transcriptomics analyses. Examples of metabolites to be analyzed are antioxidative and anti-inflammatory metabolites, neurotransmission, mitochondrial, tryptophan, and purine metabolisms. Examples of lipidomics include sphingomyelins (SMs), cholesterol esters (ChEs), phosphatidylcholines (PCs), phosphatidylethanolamines (PIs), phosphatidylinositols (PIs), and triglycerides (TGs). Transcriptomics will be used to identify changes in mRNAs involved in different pathways contributing to AD, such as genes involved in inflammation and oxidative stress, in both ApoE-dependent and independent fashion.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-07-01; most recent amendment 2025-04-18.
Status change: Not Yet Recruiting → Active, Not Recruiting 2025-04-15
Trial Details
NCT Number NCT05929924
Lead Sponsor Augusta University
Conditions Alzheimer Disease
Enrollment 40 participants
Start Date 2023-08-01
Primary Completion 2025-07-01 (estimated)
Study Completion 2025-07-01 (estimated)
Updated on ClinicalTrials.gov 2025-04-20