Olive Oil Polyphenols and Cardiovascular Health Biomarkers

NCT04149288 | Active Not Recruiting

• 1 other identifier: 1484263
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Normal Weight; Overweight; Obese; Healthy

Outcome Measures

Primary Outcomes (6)

• Assessing the influence of olive oil polyphenols on cholesterol efflux

  Cholesterol efflux will be measured by assessing changes in reverse cholesterol transport rate in separated serum at each study time point (baseline, 2 hour, 4 hour) using a commercially available assay kit at each of the 4 study visits.

  Through study completion, an average of 8 weeks

• Assessing the influence of olive oil polyphenols on cholesterol ester transfer protein activity (CETP)

  Changes in CETP activity will be measured at each study time point (baseline, 2 hour, 4 hour) in plasma at each of the 4 study visits. The isolated plasma will be co-incubated with donor and acceptor molecules using a commercially available assay kit.

  Through study completion, an average of 8 weeks

• Assessing the influence of olive oil polyphenols on circulating oxidized LDL

  Measure for changes in circulating levels of oxidized LDL in separated plasma at each study time point (baseline, 2 hour, 4 hour) using a commercially available ELISA kit; measured in units of U/L at each of the 4 study visits.

  Through study completion, an average of 8 weeks

• Assessing the influence of olive oil polyphenols on blood lipid measurements

  Measure for changes in the levels of HDL and LDL in separated plasma; measured in units of mg/dL. Blood will be assessed for the fasting (baseline) sample only at each of the 4 study visits.

  Through study completion, an average of 8 weeks

• Assessing the influence of olive oil polyphenols on paraoxonase-1 (PON-1) activity

  Measure for changes in PON-1 activity in separated plasma at each study time point (baseline, 2 hour, 4 hour) at each of the 4 study visits. Activity will be calculated based on linear rates of hydrolysis of phenyl acetate to phenol.

  Through study completion, an average of 8 weeks

• Assessing the influence of olive oil polyphenols on peripheral blood mononuclear cells (PBMC) using ex vivo stimulation assays

  Measurement of changes in PBMC derived cytokines as a marker of inflammation at each study time point (baseline, 2 hour, 4 hour) at each of the 4 study visits. Assessment will be based on an increase or decrease in concentration in pg/ml.

  Through study completion, an average of 8 weeks

Secondary Outcomes (1)

• Assessing the influence of olive oil polyphenols on gene expression in mirco RNA in PBMCs

  Through study completion, an average of 8 weeks

Other Outcomes (6)

• Food record analysis

  Through study completion, an average of 8 weeks

• Anthropometric measurements

  Through study completion, an average of 8 weeks

• Measure for changes in weight

  Through study completion, an average of 8 weeks

Study Arms (2)

High-polyphenol olive oil

ACTIVE COMPARATOR

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

Dietary Supplement: High-polyphenol olive oil

Low-polyphenol olive oil

ACTIVE COMPARATOR

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

Dietary Supplement: Low-polyphenol olive oil

Interventions

Low-polyphenol olive oil 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.

Low-polyphenol olive oil

High-polyphenol olive oil 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.

High-polyphenol olive oil

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

Ragle Human Nutrition Center

Davis, California, 95616, United States

Location

Related Links

• Learn more or sign up for the study here!

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: November 4, 2019
• Study Start: October 6, 2021
• Primary Completion (Estimated): August 22, 2026
• Study Completion (Estimated): August 22, 2026
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

US (1)