Does EVOO Induce Gene and Metabolic Changes in Healthy Subjects

NCT05929924 | Active Not Recruiting

• 1 other identifier: 23-221
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Changes in the concentrations of blood metabolites (metabolomics)

  The concentrations of blood metabolites will be measured by Mass Spectrometry and compared between the control and EVOO groups in healthy participants with AD family history.

  6 months

• Changes in the concentrations of blood mRNA transcripts (transcriptomics)

  The concentrations of blood mRNAs will be measured by microarrays and compared between the control and EVOO groups in healthy participants with AD family history.

  6 months

Study Arms (2)

Control

NO INTERVENTION

This group will not receive intervention

Extra-virgin olive oil

ACTIVE COMPARATOR

This group will receive extra-virgin olive oil (EVOO) as intervention

Dietary Supplement: Extra virgin olive oil

Interventions

Extra virgin olive oil DIETARY_SUPPLEMENT

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

Also known as: EVOO

Extra-virgin olive oil

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Smokers
• Neuropsychiatric illness including depression, anxiety, seizures, attention deficit disorders, and cognitive deficit disorders.
• Pregnant or become pregnant during the study.

Sponsors & Collaborators

• Augusta University: lead

Study Sites (1)

Augusta University

Augusta, Georgia, 30912, United States

Location

Related Publications (1)

• Kaddoumi A, Denney TS Jr, Deshpande G, Robinson JL, Beyers RJ, Redden DT, Pratico D, Kyriakides TC, Lu B, Kirby AN, Beck DT, Merner ND. Extra-Virgin Olive Oil Enhances the Blood-Brain Barrier Function in Mild Cognitive Impairment: A Randomized Controlled Trial. Nutrients. 2022 Dec 1;14(23):5102. doi: 10.3390/nu14235102.

  PMID: 36501136 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 24, 2023
• First Posted: July 3, 2023
• Study Start: August 1, 2023
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: April 20, 2025

Record last verified: 2025-04

Locations

US (1)