Cardiovascular Effects of Extra Virgin Olive Oil (EVOO) in Healthy Reproductive-aged Women: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Arterial distensibility
研究概览
简要总结
This study aims to compare changes in cardiovascular function and markers of inflammation and metabolic dysfunction in women randomized to treatment with extra virgin olive oil (EVOO) versus those randomized to treatment with a control oil low in oleic acid and phenols for 8 weeks.
详细描述
Participants will be randomized to receive 45 ml (40 g) of extra virgin olive oil (EVOO) daily for 8 weeks or an identical dose of a control sunflower seed oil low in oleic acid and phenol content. EVOO high in oleic acid and phenolic content will be identified and shipped from Italy and stored protected from heat and light in the Bionutrition Core at the Clinical Research Center at the University of Vermont Medical Center. Women will undergo a detailed cardiovascular assessment at baseline and following treatment, including assessment of blood pressure, pulse-wave velocity, calculation of arterial distensibility and beta stiffness, flow-mediated vasodilation, cardiac output, response to volume challenge and dual-energy X-ray absorptiometry (DEXA). Lipid profiles and markers of inflammation, oxidative stress and metabolic dysfunction will also be assessed at both study visits.
Investigators hypothesize that treatment with high oleic acid and phenolic EVOO will be associated with decreased blood pressure, improved vascular compliance and blood vessel function, and with improvement in lipid profile, inflammation and markers of metabolic dysfunction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women are eligible to participate if they are between the ages of 18 and 40, in good health, with regular menstrual cycles and no prior pregnancies.
排除标准
- •Routinely take medications or supplements known to affect blood pressure, heart or blood vessel function, or those with anti-inflammatory or antioxidant properties
- •Pregnancy
- •Other conditions that would impair adherence, such as allergy to olive oil or sunflower oil or difficulty swallowing
研究组 & 干预措施
Extra Virgin Olive Oil
干预措施: Extra Virgin Olive Oil (Dietary Supplement)
Control Oil
干预措施: Control Oil (Dietary Supplement)
结局指标
主要结局
Arterial distensibility
时间窗: 8 weeks
Arterial distensibility (no units). This is an index of vessel stiffness.
Arterial Beta Stiffness Index
时间窗: 8 weeks
Arterial Beta Stiffness Index (no units). This is an index of vessel stiffness.
Blood pressure
时间窗: 8 weeks
Blood pressure in millimeters mercury (mm Hg).
Arterial pulse wave velocity
时间窗: 8 weeks
Arterial pulse wave velocity in meters/second. This is an index of vessel stiffness.
次要结局
- Flow-mediated vasodilation(8 weeks)
- Cardiac output(8 weeks)
- High Density Lipoprotein (HDL) Cholesterol(1 year)
- Hemoglobin A1C(1 year)
- Cardiac output response to volume challenge(8 weeks)
- C-reactive protein(1 year)
- Insulin(1 year)
- B-type natriuretic peptide (BNP)(1 year)
- Tumor necrosis factor alpha (TNF-α)(1 year)
- Low Density Lipoprotein (LDL) Cholesterol(1 year)
- Interleukin 6 (IL-6)(1 year)
- Triglycerides(1 year)
研究者
Erin Morris
Assistant Professor, Maternal-Fetal Medicine
University of Vermont Medical Center