Extra Virgin Olive Oil for Alzheimer's Disease Risk

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether extra virgin olive oil (EVOO) can protect against Alzheimer's disease in individuals with a family history of the condition. Researchers aim to determine if consuming about two tablespoons of EVOO daily for six months affects specific body chemicals linked to Alzheimer's. Participants will be divided into two groups: one taking EVOO and the other not, with both receiving brain health tips. The trial is ideal for healthy individuals with a family history of Alzheimer's but excludes smokers and those with certain mental health issues. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research on Alzheimer's prevention.

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.

Is there any evidence suggesting that extra virgin olive oil is likely to be safe for humans?

Research has shown that extra virgin olive oil (EVOO) is generally safe for people. Studies have found that EVOO offers several health benefits, such as possibly reducing the risk of Alzheimer's disease. People tolerate it well when consumed in normal amounts as part of a diet.

In Mediterranean countries, where olive oil is commonly used, older adults experience fewer cases of dementia. This suggests that regular consumption is not only safe but may also support brain health. No major reports of negative effects from consuming EVOO have emerged in these areas.

Overall, EVOO is considered safe for most people, and many find it easy to incorporate into their daily meals. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for Alzheimer's, which often involve medications targeting symptoms or brain chemistry, extra virgin olive oil (EVOO) offers a natural approach that may help reduce disease risk. Researchers are excited about EVOO because it contains powerful antioxidants and healthy fats, which are believed to support brain health and potentially slow down cognitive decline. This approach is unique because it leverages a dietary component rather than pharmaceuticals, making it a promising and accessible option for long-term prevention.

What evidence suggests that extra virgin olive oil might be an effective treatment for Alzheimer's disease risk?

Research has shown that extra virgin olive oil (EVOO) might help protect against Alzheimer's disease. One study found that people who consumed more than 7 grams of olive oil daily had a 28% lower risk of dying from dementia-related causes. Other research suggests that EVOO can improve thinking and memory in people with mild cognitive impairment (MCI). EVOO may also lower the risk of developing MCI and Alzheimer's by supporting brain health. These benefits likely stem from the antioxidant and anti-inflammatory properties in olive oil. In this trial, one group will receive EVOO as an intervention to further explore these potential benefits. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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

Pregnant or become pregnant during the study

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

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10856527/

Extra-Virgin Olive Oil in Alzheimer's Disease - PubMed Central EVOO and other olive-related phenolic compounds have been shown to reduce the risk of developing mild cognitive impairment (MCI) and AD.

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2818362

Consumption of Olive Oil and Diet Quality and Risk ... The consumption of more than 7 g/d of olive oil was associated with a 28% lower risk of dementia-related death compared with never or rarely consuming olive ...

3. ysph.yale.edu ysph.yale.edu/news-article/assistant-professor-tassos-c-kyriakides-discusses-the-cognitive-benefits-of-olive-oil/

Assistant Professor Tassos C. Kyriakides discusses the ... Tassos C. Kyriakides finds that the daily consumption of extra-virgin olive oil could improve cognitive function in individuals with mild cognitive impairment.

4. alzdiscovery.org alzdiscovery.org/uploads/cognitive_vitality_media/Olive-Oil-Cognitive-Vitality-For-Researchers.pdf

Olive Oil Neuroprotective Benefit: May slightly improve cognition when extra virgin olive oil is consumed as part of a Mediterranean diet, but direct evidence for ...

5. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2023.1218538/full

The effects of olive oil consumption on cognitive performance Conclusion: The consumption of olive oil was found to enhance cognitive functioning and to reduce cognitive decline. Further large-scale ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4679638/

Extra-Virgin Olive Oil Attenuates Amyloid-β and Tau ... Several studies have suggested that EVOO has several health promoting effects that could protect from and decrease the risk of Alzheimer's disease (AD).

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0531556521001194

The pleiotropic beneficial intervention of olive oil intake on ... Evidence has shown that Mediterranean populations emerge a smaller prevalence of dementia in the elderly thanks to the consumption of olive oil ...

8. austinpublishinggroup.com austinpublishinggroup.com/food-sciences/fulltext/afs-v9-id1056.pdf

Effect of Extra Virgin Olive Oil Consumption on ... The aim of this mini review is to highlight the recent findings demonstrating the beneficial role of EVOO on degenerative disorders by ...