Olive Oil Polyphenols and Cardiovascular Health Biomarkers

NCT ID: NCT04149288

Last Updated: 2026-01-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-06
• Study Completion Date: 2026-08-22

Brief Summary

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.

Detailed Description

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. Healthy individuals aged 20-45 with a BMI over 20 kg/m2 are eligible to participate. The study involves 5 visits (1 initial screening and 4 study visits) and will last about 8 weeks. There is a 2-week run-in period before starting the study, followed by two diet intervention periods each lasting two weeks, separated by a two-week washout period.

Participation in this study will involve an initial two-week run in period to become accustomed to the study diet. After this two week period, participants will be randomly selected to start either a high-polyphenol olive oil (extra virgin olive oil) or a low-polyphenol olive oil (refined olive oil); participants will consume the other oil during the second dietary intervention period lasting 2 weeks. During each phase of the study, participants will be asked to come to the University of California, Davis campus after a 10-12 hour overnight fast. At each visit, body measurements will be taken, a serving of olive oil and bread will be eaten, and three urine and blood samples will be collected over the course of 4 hours. Each study visit will involve three blood draws by a trained nurse or phlebotomist.

During the 8 weeks of the study, all olive products such as olives, olive oil, and olive containing products will need to be avoided. The study will provide olive oil to be eaten at home for each intervention phase. Additionally, the investigators will ask that nuts and high-polyphenol foods (mostly fruits and vegetables) be avoided in the diet. Detailed food diaries will be filled out and brought to study visits.

Conditions

Healthy; Normal Weight; Overweight; Obese

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

High-polyphenol olive oil

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

Group Type: ACTIVE_COMPARATOR

High-polyphenol olive oil

Intervention Type: DIETARY_SUPPLEMENT

High-polyphenol olive oil will be provided to study participants to consume at home. Participants will be asked to consume 40 mL each day for 2 weeks.

Low-polyphenol olive oil

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

Group Type: ACTIVE_COMPARATOR

Low-polyphenol olive oil

Intervention Type: DIETARY_SUPPLEMENT

Low-polyphenol olive oil will be provided to study participants to consume at home. Participants will be asked to consume 40 mL each day for 2 weeks.

Interventions

High-polyphenol olive oil

High-polyphenol olive oil will be provided to study participants to consume at home. Participants will be asked to consume 40 mL each day for 2 weeks.

Intervention Type: DIETARY_SUPPLEMENT

Low-polyphenol olive oil

Low-polyphenol olive oil will be provided to study participants to consume at home. Participants will be asked to consume 40 mL each day for 2 weeks.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Generally healthy male and female subjects within the range of 20-45 years of age and BMI range of 18.5-29.9 kg/m2 for the healthy weight/overweight group and ≥ 30 kg/m2 for the obese group will be recruited.

Exclusion Criteria

• Adults unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant or lactating women, women planning to become pregnant in the next two months and prisoners will be specifically excluded
• Documented chronic diseases including diabetes, thyroid disease, kidney disease, metabolic syndrome, active cancer, previous cardiovascular events, history of gastric bypass or other GI issues related to fat absorption
• History of dyslipidemia or abnormal blood glucose levels (total cholesterol >240 mg/dL, elevated fasting blood glucose levels >125 mg/dL)
• Allergy to olives, inability to tolerate gluten or multiple allergies/intolerances that would significantly limit food intake
• Smoker or living with a smoker, illicit drug use, consuming >1 alcoholic drink/day, vaporizer and/or electronic cigarette use
• Extreme dietary or exercise patterns
• Recent weight fluctuations (>10% in the last 6 months)
• Taking prescription lipid medications or supplements that may affect lipoprotein metabolism, >1 g of fish oil/day, antioxidant supplements, cannabidiol (CBD) oil
• Taking exogenous hormones (e.g. hormonal birth control)
• Poor venous access
• Unwillingness to comply with study protocol

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ragle Human Nutrition Center

Davis, California, United States

Countries

United States

Related Links

https://studypages.com/s/a-study-of-olive-oil-polyphenols-molecules-in-plant-based-food-and-cardiovascular-health-273896/

Learn more or sign up for the study here!

Other Identifiers

1484263

Identifier Type: -

Identifier Source: org_study_id