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ACTIVE NOT RECRUITING
NCT05929924
NA

Does EVOO Induce Gene and Metabolic Changes in Healthy Subjects

Sponsor: Augusta University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

30 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2023-08-01

Completion Date

2025-07-01

Last Updated

2025-04-20

Healthy Volunteers

Yes

Interventions

DIETARY_SUPPLEMENT

Extra virgin olive oil

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

Locations (1)

Augusta University

Augusta, Georgia, United States