TrialGlobe

Clinical trial

Olive Oil Polyphenols and Cardiovascular Health Biomarkers

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT04149288

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age20 Years to 45 Years
SexAll
Healthy volunteersAccepted
ConditionHealthy, Normal Weight, Overweight, Obese

Full registry 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

Treatments and study arms

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.

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.

Primary outcomes

Assessing the influence of olive oil polyphenols on cholesterol effluxThrough study completion, an average of 8 weeks

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.

Assessing the influence of olive oil polyphenols on cholesterol ester transfer protein activity (CETP)Through study completion, an average of 8 weeks

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.

Assessing the influence of olive oil polyphenols on circulating oxidized LDLThrough study completion, an average of 8 weeks

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.

Assessing the influence of olive oil polyphenols on blood lipid measurementsThrough study completion, an average of 8 weeks

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.

Assessing the influence of olive oil polyphenols on paraoxonase-1 (PON-1) activityThrough study completion, an average of 8 weeks

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.

Assessing the influence of olive oil polyphenols on peripheral blood mononuclear cells (PBMC) using ex vivo stimulation assaysThrough study completion, an average of 8 weeks

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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Ragle Human Nutrition Center🇺🇸 Davis, California, United States
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