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NCT05929924 · ClinicalTrials.gov registry record · NA

Does EVOO Induce Gene and Metabolic Changes in Healthy Subjects

A NA study of Alzheimer Disease, sponsored by Augusta University.

Active
Registry status
NA
Development phase
40
Enrollment target
1
Study location

NCT05929924 is a NA study of Alzheimer Disease that is active but no longer recruiting, run by Augusta University. The registered enrollment target is 40 participants, below the 2,751-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05929924, a NA study of Alzheimer Disease, is active but no longer recruiting, sponsored by Augusta University.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
40 participants
Enrollment target
1
Study location

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 Studied

Interventions

  • DIETARY_SUPPLEMENT Extra virgin olive oil

Study Locations (1)

Georgia

  • Augusta University - Augusta

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2023-08-01
Est. Completion 2025-07-01
Phase NA

Sponsor

Augusta University

106 total trials

What the Registry Record Tells You About NCT05929924

The ClinicalTrials.gov registry entry for NCT05929924 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,751-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (99% lower). The listed sponsor is Augusta University, which has 106 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Alzheimer Disease appearing as the primary indexed condition, and to 1 intervention - of which Extra virgin olive oil is the first listed.

NCT05929924 reports 1 study location spanning 1 distinct geographic area - top geographies include Georgia.

Frequently Asked Questions

What is clinical trial NCT05929924 about?

NCT05929924 is a clinical study titled "Does EVOO Induce Gene and Metabolic Changes in Healthy Subjects". 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 health...

What is the current status of trial NCT05929924?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 40 participants. The study started on 2023-08-01. Estimated completion is 2025-07-01.

What conditions does trial NCT05929924 study?

This clinical trial studies the following conditions: Alzheimer Disease.

What interventions are being tested in trial NCT05929924?

The interventions under investigation include: Extra virgin olive oil (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT05929924?

This trial is sponsored by Augusta University, which has 106 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05929924 being conducted?

This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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