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NCT05929924Completed

Does EVOO Induce Gene and Metabolic Changes in Healthy Subjects

Does EVOO Induce Gene and Metabolic Changes in Healthy Subjects With Alzheimer's Disease Family History

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
39 (actual)
First submitted
24 Jun 2023
Start date
1 Aug 2023
Primary completion date
1 Jul 2025
Lead sponsor
Augusta University
NCT number
NCT05929924

What you commit to

  • Study type: Interventional
  • Participants enrolled: 39
  • From 1 Aug 2023 to the primary completion date, 1 Jul 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Neuropsychiatric illness including depression, anxiety, seizures, attention deficit disorders, and cognitive deficit disorders.

Other

  • Smokers
  • Pregnant or become pregnant during the study.

Who the study is looking for

  • Cognitively normal and healthy individuals
  • Have a family history of Alzheimer's disease.

Age in the registry: 30 years to 55 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Augusta University
Coordinator of this site? Confirm its status
AugustaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.