Extra Virgin Olive Oil for Alzheimer's Disease Risk

Recruiting at 1 trial location

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Augusta University

Disqualifiers: Smokers, Neuropsychiatric illness, Pregnancy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 6 months

40 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment extra virgin olive oil for Alzheimer's disease risk?

Research suggests that extra virgin olive oil, a key part of the Mediterranean diet, may help protect against Alzheimer's disease by improving brain function and reducing harmful protein build-up in the brain. Studies have shown that it can enhance memory and brain connectivity, and lower the risk of cognitive decline. ^{1 2 3 4 5}

Is extra virgin olive oil safe for human consumption?

Extra virgin olive oil is generally considered safe for human consumption and is a key component of the Mediterranean diet, which is associated with various health benefits, including lower risks of heart disease and cognitive decline. ^{1 3 5 6 7}

How does extra virgin olive oil treatment differ from other Alzheimer's treatments?

Extra virgin olive oil is unique because it is a natural dietary component rich in monounsaturated fats and polyphenols, which may help prevent Alzheimer's by reducing inflammation and amyloid plaque formation in the brain, unlike traditional medications that primarily target symptoms. ^{1 6 8 9 10}

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for healthy individuals with a family history of Alzheimer's Disease. Participants should be cognitively normal and not have any neuropsychiatric illnesses like depression or anxiety. Smokers and pregnant women, or those who become pregnant during the study, are excluded.

Inclusion Criteria

I am mentally healthy and have a family history of Alzheimer's.

Exclusion Criteria

Smokers

I have a mental health or neurological condition like depression, anxiety, or ADHD.

Pregnant or become pregnant during the study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Blood samples collected for ApoE genotyping and baseline metabolomics, lipidomics, and transcriptomics analyses

1 week

1 visit (in-person)

Treatment

Participants receive daily EVOO or no intervention for 6 months

6 months

Monthly check-ins (virtual)

Follow-up

Blood samples collected to evaluate the effect of EVOO on metabolites, lipids, and genes

1 week

1 visit (in-person)

Treatment Details

Interventions

• Extra virgin olive oil

Trial Overview The study tests if consuming extra virgin olive oil (EVOO) daily (~2 tablespoons) can induce beneficial gene and metabolic changes in healthy subjects at risk for Alzheimer's due to family history. Blood samples will be analyzed before and after six months of EVOO intake.

Participant Groups

Group I: Control Active Control 1 Intervention

This group will not receive intervention

Group II: Extra-virgin olive oil Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Augusta University

Lead Sponsor

Trials

219

Recruited

85,900+

Auburn University

Lead Sponsor

Trials

81

Recruited

14,600+

Findings from Research

In a randomized clinical trial involving 204 Alzheimer's disease patients, omega-3 supplementation did not show significant overall effects on neuropsychiatric symptoms or daily functioning, but did improve agitation in APOE4 carriers and depressive symptoms in non-APOE4 carriers.

The study highlights that while omega-3 fatty acids may not universally benefit all Alzheimer's patients, they could provide targeted improvements in specific symptoms based on genetic factors, suggesting a need for personalized treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omega-3 supplementation in mild to moderate Alzheimer's disease: effects on neuropsychiatric symptoms. Freund-Levi, Y., Basun, H., Cederholm, T., et al.[2018]

References

1. France pubmed.ncbi.nlm.nih.gov

Extra-virgin olive oil for potential prevention of Alzheimer disease. [2020]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Vegetables, unsaturated fats, moderate alcohol intake, and mild cognitive impairment. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Olive Oil Phenols as Promising Multi-targeting Agents Against Alzheimer's Disease. [2016]

4. England pubmed.ncbi.nlm.nih.gov

Effect of the replacement of dietary vegetable oils with a low dose of extravirgin olive oil in the Mediterranean Diet on cognitive functions in the elderly. [2019]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Extra-Virgin Olive Oil Enhances the Blood-Brain Barrier Function in Mild Cognitive Impairment: A Randomized Controlled Trial. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Olive oil and cognition: results from the three-city study. [2021]

7. England pubmed.ncbi.nlm.nih.gov

The pleiotropic beneficial intervention of olive oil intake on the Alzheimer's disease onset via fibrinolytic system. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Omega-3 supplementation in mild to moderate Alzheimer's disease: effects on neuropsychiatric symptoms. [2018]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Comparison of Oleocanthal-Low EVOO and Oleocanthal against Amyloid-β and Related Pathology in a Mouse Model of Alzheimer's Disease. [2023]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Oleuropein aglycone: A polyphenol with different targets against amyloid toxicity. [2019]