Olive Oil Polyphenols and Cardiovascular Health Biomarkers
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Assessing the influence of olive oil polyphenols on circulating oxidized LDL
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
High-polyphenol olive oil
Participants will consume 40 mL of high-polyphenol olive oil each day at home for 2 weeks.
干预措施: High-polyphenol olive oil (Dietary Supplement)
Low-polyphenol olive oil
Participants will consume 40 mL of low-polyphenol olive oil each day at home for 2 weeks.
干预措施: Low-polyphenol olive oil (Dietary Supplement)
结局指标
主要结局
Assessing the influence of olive oil polyphenols on circulating oxidized LDL
时间窗: Through 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 cholesterol efflux
时间窗: Through 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 paraoxonase-1 (PON-1) activity
时间窗: Through 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 cholesterol ester transfer protein activity (CETP)
时间窗: 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 blood lipid measurements
时间窗: Through 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 peripheral blood mononuclear cells (PBMC) using ex vivo stimulation assays
时间窗: Through 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.
次要结局
- Assessing the influence of olive oil polyphenols on gene expression in mirco RNA in PBMCs(Through study completion, an average of 8 weeks)