Olive Oil Polyphenols for Cardiovascular Health

FM
JR
Overseen ByJody Randolph, MS
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if different types of olive oil can alter factors affecting heart health, such as cholesterol and inflammation. Participants will consume either high-polyphenol or low-polyphenol olive oil daily for two weeks. The trial seeks generally healthy adults without chronic illnesses like diabetes or heart issues. It may suit individuals without major health conditions who wish to explore how olive oil might impact their heart health. As an unphased trial, this study offers a unique opportunity to contribute to understanding the potential heart health benefits of olive oil.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as prescription lipid medications, supplements affecting lipoprotein metabolism, more than 1 gram of fish oil per day, antioxidant supplements, and cannabidiol (CBD) oil. If you are taking these, you may need to stop before participating.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using olive oil can lower the risk of heart disease. People who consume more olive oil, especially varieties high in polyphenols, tend to experience fewer heart problems. For instance, regular olive oil users have seen a 14% reduction in heart disease cases. This type of olive oil contains extra antioxidants, which benefit heart health.

Low-polyphenol olive oil also offers advantages. It helps the body manage bad cholesterol more effectively. Even just two tablespoons a day can reduce heart disease risk by about 8%.

Both types of olive oil appear safe for most people. Studies have not identified any major side effects, indicating these oils are likely well-tolerated.12345

Why are researchers excited about this trial's treatments?

Unlike many common treatments for cardiovascular health that rely on medications, these investigational treatments use olive oil, specifically focusing on its polyphenol content. High-polyphenol olive oil is unique because it harnesses natural antioxidants that may improve heart health more effectively than oils with lower polyphenol levels. Researchers are excited about this approach because it offers a dietary solution that could enhance cardiovascular health with potentially fewer side effects than traditional pharmaceuticals. Plus, incorporating olive oil into daily meals is simple and could make managing heart health more accessible and sustainable for many people.

What evidence suggests that this trial's treatments could be effective for cardiovascular health?

This trial will compare the effects of high-polyphenol olive oil and low-polyphenol olive oil on cardiovascular health. Research has shown that olive oil with high levels of polyphenols can lower the risk of heart disease. Studies have found it reduces both high blood pressure and bad LDL cholesterol. Specifically, one study discovered that people who used more olive oil had a 14% lower chance of developing heart disease. While there is less information about the heart benefits of olive oil with low polyphenol levels, using any olive oil is generally linked to lower heart disease rates. This suggests that both types of olive oil might support heart health, but high-polyphenol olive oil could offer greater benefits.14678

Are You a Good Fit for This Trial?

This trial is for generally healthy men and women aged 20-45 with a BMI of 18.5-29.9 or ≥30 for obese individuals. Exclusions include smokers, heavy alcohol users, drug users, those unable to consent, pregnant/lactating women, people with high cholesterol or blood sugar levels, olive allergies, extreme diets/exercise habits, certain chronic diseases or medication use.

Inclusion Criteria

I am between 20-45 years old and my BMI is either in the healthy to overweight range or I am considered obese.

Exclusion Criteria

I have a chronic condition like diabetes, thyroid, kidney disease, or a history of heart issues.
My weight has changed by more than 10% in the last 6 months.
I am currently taking hormonal medications, like birth control.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 visit
1 visit (in-person)

Run-in

Participants undergo a two-week run-in period to become accustomed to the study diet

2 weeks

Dietary Intervention 1

Participants consume either high-polyphenol or low-polyphenol olive oil for 2 weeks

2 weeks
2 visits (in-person)

Washout

Participants undergo a two-week washout period between dietary interventions

2 weeks

Dietary Intervention 2

Participants consume the alternate olive oil (high-polyphenol or low-polyphenol) for 2 weeks

2 weeks
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • High-polyphenol olive oil
  • Low-polyphenol olive oil
Trial Overview The study aims to see if consuming low-polyphenol versus high-polyphenol olive oil affects cardiovascular health markers like good/bad cholesterol levels, inflammation indicators and gene expression related to heart disease risk in healthy/overweight and obese participants.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: High-polyphenol olive oilActive Control1 Intervention
Group II: Low-polyphenol olive oilActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials
958
Recruited
4,816,000+

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/29708409/
The effect of high-polyphenol extra virgin olive oil on ...High polyphenol oils confer some CVD-risk reduction benefits; however, further studies with longer duration and in non-Mediterranean populations are required.
Protective effects of oleic acid and polyphenols in extra ...People who consumed high levels of OO (> 7 g/day) had a 14 % reduction in the CVDs prevalence and an 18 % reduction in the coronary heart disease prevalence ...
Olive Oil Polyphenols and Cardiovascular Health BiomarkersThe purpose of this research is to investigate whether consuming two different kinds of olive oil will change risk factors related to cardiovascular disease ...
Review shows how extra virgin olive oil transforms heart ...Studies in Australian adults have shown that high-polyphenol olive oil significantly reduces systolic blood pressure and ox-LDL levels, ...
Cardiovascular and Metabolic Benefits of Extra Virgin Olive ...Among the main outcomes, a decrease in weight, BMI, and blood glucose after treatment with EVOO in comparison with OO was found, as well as an increase in ...
Olive oil consumption and risk of cardiovascular disease ...In summary, olive oil consumption was associated with reduced risks of CVD events and all-cause mortality. Consuming olive oil up to 20 g/days may be optional, ...
Olive Oil Consumption and Cardiovascular Risk in U.S. AdultsHigher olive oil intake was associated with lower risk of CHD and total CVD in two large prospective cohorts of U.S. men and women. The substitution of ...
Limitations and future directions of current supplement formThe effect of high-polyphenol extra virgin olive oil on cardiovascular risk factors: a systematic review and meta-analysis. Crit Rev Food ...
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