Olive Oil Polyphenols for Cardiovascular Health

Overseen By Jody Randolph, MS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

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

Compensation: Varies

Number of Visits: 5

44 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this research is to investigate whether consuming two different kinds of olive oil will change risk factors related to cardiovascular disease, including levels of good and bad cholesterol, levels of inflammation, and levels of gene expression.

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.

What data supports the effectiveness of the treatment High-polyphenol olive oil for cardiovascular health?

Research shows that high-polyphenol olive oil can improve heart health by reducing bad cholesterol (LDL), lowering inflammation, and decreasing blood pressure. These benefits are linked to the antioxidant and anti-inflammatory properties of the polyphenols in the olive oil. ^{1 2 3 4 5}

Is high-polyphenol olive oil safe for human consumption?

Research shows that high-polyphenol olive oil is generally safe for humans and may even offer health benefits like reducing inflammation and improving heart health. ^{1 2 4 6 7}

How does high-polyphenol olive oil treatment differ from other cardiovascular treatments?

High-polyphenol olive oil is unique because it uses natural compounds called polyphenols, found in extra-virgin olive oil, to improve heart health by reducing bad cholesterol and inflammation. Unlike many standard cardiovascular treatments, it focuses on dietary intake rather than medication. ^{1 2 3 5 7}

Eligibility Criteria

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: High-polyphenol olive oil Active Control 1 Intervention

Participants will consume 40 mL of high-polyphenol olive oil each day at home for 2 weeks.

Group II: Low-polyphenol olive oil Active Control 1 Intervention

Participants will consume 40 mL of low-polyphenol olive oil each day at home for 2 weeks.

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

References

1. Germany pubmed.ncbi.nlm.nih.gov

Extra virgin olive oil high in polyphenols improves antioxidant status in adults: a double-blind, randomized, controlled, cross-over study (OLIVAUS). [2022]

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

The effect of high-polyphenol extra virgin olive oil on cardiovascular risk factors: A systematic review and meta-analysis. [2020]

3. Australia pubmed.ncbi.nlm.nih.gov

Effect of high polyphenol extra virgin olive oil on markers of cardiovascular disease risk in healthy Australian adults (OLIVAUS): A protocol for a double-blind randomised, controlled, cross-over study. [2021]

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

Olive oil polyphenols decrease blood pressure and improve endothelial function in young women with mild hypertension. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Effect of polyphenol-rich extra-virgin olive oil on lipid profile and inflammatory biomarkers in patients undergoing coronary angiography: a randomised, controlled, clinical trial. [2021]

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

Effects of postprandial hydroxytyrosol and derivates on oxidation of LDL, cardiometabolic state and gene expression: a nutrigenomic approach for cardiovascular prevention. [2019]

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

Olive oil intake and risk of cardiovascular disease and mortality in the PREDIMED Study. [2022]