Alzheimer DiseaseNCT05929924
Does EVOO Induce Gene and Metabolic Changes in Healthy Subjects
A study testing Extra virgin olive oil in people with Alzheimer Disease, run by Augusta University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Extra virgin olive oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2023to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Cognitively normal and healthy individuals
- Have a family history of Alzheimer's disease.
Who cannot join
- Smokers
- Neuropsychiatric illness including depression, anxiety, seizures, attention deficit disorders, and cognitive deficit disorders.
- Pregnant or become pregnant during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does EVOO Induce Gene and Metabolic Changes in Healthy Subjects With Alzheimer's Disease Family History
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.
Read the detailed description
Several epidemiological and clinical studies proposed that adherence to the Mediterranean diet improves cognitive function and slows Alzheimer's disease (AD) progression. Extra virgin olive oil (EVOO) is one of the main elements of the Mediterranean diet. EVOO provides several health benefits, including strong anti-inflammatory and antioxidant effects. Findings from our preclinical published studies support the consumption of EVOO to protect the brain, prevent AD and delay disease progression. In addition, findings from the investigators' pilot clinical trial in mild cognitive impairment (MCI) individuals demonstrated EVOO improved cerebrovascular function and memory. However, the remaining question is whether EVOO could protect individuals from AD in individuals with a family history of AD, i.e., with a genetic predisposition. One of the major risk factors for AD is the genetic variation in apolipoprotein E (ApoE). ApoE is a major risk factor for developing late-onset AD, with ApoE4 being detrimental and ApoE2 protective. Compared to the most common ApoE3/3 genotype, each additional copy of the ApoE4 allele is associated with an increased risk of AD and a younger mean age at dementia onset, such that ApoE4 homozygotes are at the highest risk. Available reports have shown ApoE4 carriers have increased amyloid-β (Aβ) brain levels contributing to its accumulation and related pathology. Also, ApoE4 contributes to cerebrovascular dysfunction, increasing susceptibility to neurodegenerative insult. Besides, compared to ApoE3, ApoE4 carriers may not respond to some drugs suggesting the efficacy is ApoE genotype dependent. However, whether EVOO protective effect could extend to those with a family history of AD, i.e., with a genetic predisposition, specifically ApoE4, is unknown. Thus, the objectives of this study are: 1) To evaluate the effect of EVOO on molecular and biological pathways linked with AD by monitoring changes in blood metabolites (metabolomics), lipids (lipidomics), and genes (transcriptomics); and 2): To compare the effect of EVOO on analyzed pathways between individuals with ApoE3 and ApoE4. To accomplish both specific aims, the investigators will recruit healthy individuals with a family history of AD for participation. At baseline, blood samples will be collected from eligible participants for ApoE genotyping and metabolomics, lipidomics, and transcriptomics analyses. Participants will be randomized into 2 groups (n=20 each); one group will receive daily EVOO (~2 tablespoons, 30 ml per day) for 6 months, and the second group will not receive olive oil. After 6 months, another blood sample will be collected from the participants to evaluate the effect of EVOO on metabolites, lipids, and genes.
- Conditions
- Alzheimer Disease
- Being tested
- Extra virgin olive oil
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extra virgin olive oilDietary supplement
Also called EVOO
EVOO will be included in the participant's daily diet for 6 months
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Extra virgin olive oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start1 Aug 2023
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amal Kaddoumi, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05929924
- Sponsor's protocol ID
- 23-221
- Status last verified
- Apr 2025
- First submitted
- 24 Jun 2023
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36501136
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does EVOO Induce Gene and Metabolic Changes in Healthy Subjects With Alzheimer's Disease Family History
- ClinicalTrials.gov ID
- NCT05929924
- Acronym / sponsor ID
- 23-221
- Conditions
- Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Several epidemiological and clinical studies proposed that adherence to the Mediterranean diet improves cognitive function and slows Alzheimer's disease (AD) progression. Extra virgin olive oil (EVOO) is one of the main elements of the Mediterranean diet. EVOO provides several health benefits, including strong anti-inflammatory and antioxidant effects. Findings from our preclinical published studies support the consumption of EVOO to protect the brain, prevent AD and delay disease progression. In addition, findings from the investigators' pilot clinical trial in mild cognitive impairment (MCI) individuals demonstrated EVOO improved cerebrovascular function and memory. However, the remaining question is whether EVOO could protect individuals from AD in individuals with a family history of AD, i.e., with a genetic predisposition. One of the major risk factors for AD is the genetic variation in apolipoprotein E (ApoE). ApoE is a major risk factor for developing late-onset AD, with ApoE4 being detrimental and ApoE2 protective. Compared to the most common ApoE3/3 genotype, each additional copy of the ApoE4 allele is associated with an increased risk of AD and a younger mean age at dementia onset, such that ApoE4 homozygotes are at the highest risk. Available reports have shown ApoE4 carriers have increased amyloid-β (Aβ) brain levels contributing to its accumulation and related pathology. Also, ApoE4 contributes to cerebrovascular dysfunction, increasing susceptibility to neurodegenerative insult. Besides, compared to ApoE3, ApoE4 carriers may not respond to some drugs suggesting the efficacy is ApoE genotype dependent. However, whether EVOO protective effect could extend to those with a family history of AD, i.e., with a genetic predisposition, specifically ApoE4, is unknown. Thus, the objectives of this study are: 1) To evaluate the effect of EVOO on molecular and biological pathways linked with AD by monitoring changes in blood metabolites (metabolomics), lipids (lipidomics), and genes (transcriptomics); and 2): To compare the effect of EVOO on analyzed pathways between individuals with ApoE3 and ApoE4. To accomplish both specific aims, the investigators will recruit healthy individuals with a family history of AD for participation. At baseline, blood samples will be collected from eligible participants for ApoE genotyping and metabolomics, lipidomics, and transcriptomics analyses. Participants will be randomized into 2 groups (n=20 each); one group will receive daily EVOO (~2 tablespoons, 30 ml per day) for 6 months, and the second group will not receive olive oil. After 6 months, another blood sample will be collected from the participants to evaluate the effect of EVOO on metabolites, lipids, and genes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –This group will not receive intervention |
| Extra-virgin olive oil | Active comparator | Dietary Supplement: Extra virgin olive oilThis group will receive extra-virgin olive oil (EVOO) as intervention |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Cognitively normal and healthy individuals
- Have a family history of Alzheimer's disease.
Key exclusion criteria (3 listed)
- Smokers
- Neuropsychiatric illness including depression, anxiety, seizures, attention deficit disorders, and cognitive deficit disorders.
- Pregnant or become pregnant during the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extra virgin olive oilAlso: EVOOEVOO will be included in the participant's daily diet for 6 months | Dietary supplement | Extra-virgin olive oil |
Primary outcome
Changes in the concentrations of blood metabolites (metabolomics)
Time frame: 6 months
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.
Changes in the concentrations of blood mRNA transcripts (transcriptomics)
Time frame: 6 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Background: PubMed 36501136Kaddoumi 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extra virgin olive oil in people with Alzheimer Disease, run by Augusta University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the concentrations of blood metabolites (metabolomics) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05929924, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.