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Does EVOO Induce Gene and Metabolic Changes in Healthy Subjects

NCT05929924 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-04-20

No results posted yet for this study

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.

Conditions

  • Alzheimer Disease

Interventions

DIETARY_SUPPLEMENT

Extra virgin olive oil

EVOO will be included in the participant's daily diet for 6 months

Sponsors & Collaborators

  • Augusta University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2025-07-01
Completion
2025-07-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05929924 on ClinicalTrials.gov