A Multicenter Pilot Study to Evaluate the Effect of EVOO on Lipid Parameters
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 3
- 主要终点
- HDL
研究概览
简要总结
The purpose of this multi-center, double-blinded pilot study is to determine if extra virgin olive oil (EVOO) has a positive effect on HDL cholesterol levels and anti-inflammatory markers for subjects diagnosed with cardiovascular disease (CVD) and to determine if the polyphenol concentration is proportional to those effects. Subjects will complete consecutive 28-day periods (with a 14-day washout between) in which they will either consume the low polyphenol concentration EVOO daily or the high polyphenol concentration EVOO. In a double-blinded manner, each subject will be his or her own control with a 14-day washout between study periods. HDL levels and other parameters will be measured after each period of the protocol. The investigators anticipate HDL levels will improve with both olive oils. The investigators expect the high polyphenol concentration EVOO will show a greater effect than the EVOO with a low polyphenol concentration. EVOO with high polyphenol concentration may be a simple method to reduce the risk of secondary CVD events.
详细描述
Study Design:
A multi-center, double-blinded pilot study to determine if extra virgin olive oil (EVOO) has a positive effect on HDL cholesterol levels and anti-inflammatory markers for subjects diagnosed with cardiovascular disease (CVD) and to determine if the polyphenol concentration is proportional to those effects. Subjects will complete consecutive 28-day periods (with a 14-day washout between) in which they will either consume the low polyphenol concentration EVOO daily or the high polyphenol concentration EVOO. In a double-blinded manner, each subject will be his or her own control with a 14-day washout between study periods.
Hypothesis:
Subjects will demonstrate greater improvements in HDL cholesterol levels, other lipid parameters, and inflammatory markers by adding EVOO to their diets. Consumption of EVOO with high polyphenol concentration will improve these parameters more than consumption of EVOO with low polyphenol concentration.
Specific Aims:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Pharmacists will assign participants to one of the research arms following a randomization schedule, and will maintain a study log not accessible to the investigators or care provider. Study coordinators will remain blinded when distributing the bottles of EVOO.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years of age or older
- •Both males and females will be included
- •Known cardiovascular disease as documented by ICD code
- •HDL < 40 documented within the past 12 months
- •Able to fast for 12 hours prior to blood draws
排除标准
- •Unwilling or unable to provide informed consent for any reason
- •Inability to adhere to protocol for any reason
- •Currently using EVOO on a daily basis
- •Change in use of lipid lowering medications or supplements in the past 90 days or plans to change during study participation
- •HDL > 40 on baseline blood draw
- •Significant change in diet or exercise in the past 30 days or plan to do so during the study time period
- •Allergic to olive oil
- •Unable to fast for 12 hours prior to blood draws
- •Pregnancy
- •Enrolled in another interventional research study
- •Non-English speaking
研究组 & 干预措施
Low-to-High group
As this is a crossover study, each participant will be assigned to each treatment intervention. Participants (randomly) assigned to Arm 1 will first receive low polyphenol concentration EVOO for consumption, followed by high polyphenol concentration EVOO for consumption following a 14- day washout phase.
干预措施: Low polyphenol concentration extra virgin olive oil (EVOO) (Dietary Supplement)
Low-to-High group
As this is a crossover study, each participant will be assigned to each treatment intervention. Participants (randomly) assigned to Arm 1 will first receive low polyphenol concentration EVOO for consumption, followed by high polyphenol concentration EVOO for consumption following a 14- day washout phase.
干预措施: High polyphenol concentration extra virgin olive oil (EVOO) (Dietary Supplement)
High-to-Low group
As this is a crossover study, each participant will be assigned to each treatment intervention. Participants (randomly) assigned to Arm 2 will first receive high polyphenol concentration EVOO for consumption, followed by low polyphenol concentration EVOO for consumption following a 14- day washout phase.
干预措施: Low polyphenol concentration extra virgin olive oil (EVOO) (Dietary Supplement)
High-to-Low group
As this is a crossover study, each participant will be assigned to each treatment intervention. Participants (randomly) assigned to Arm 2 will first receive high polyphenol concentration EVOO for consumption, followed by low polyphenol concentration EVOO for consumption following a 14- day washout phase.
干预措施: High polyphenol concentration extra virgin olive oil (EVOO) (Dietary Supplement)
结局指标
主要结局
HDL
时间窗: HDL will be measured in each subject within 28 days before and within 28 days after consuming either low or high polyphenol EVOO.
Average difference in HDL in subjects who consumed low polyphenol vs. high polyphenol EVOO.
次要结局
- Blood pressure(Blood pressure will be measured in each subject within 28 days before and within 28 days after consuming either low or high polyphenol EVOO.)
- CRP(CRP will be measured in each subject within 28 days before and within 28 days after consuming either low or high polyphenol EVOO.)
- Lipid panel(Lipid panels will be measured in each subject within 28 days before and within 28 days after consuming either low or high polyphenol EVOO.)
- IL-6(IL-6 will be measured in each subject within 28 days before and within 28 days after consuming either low or high polyphenol EVOO.)
- Heart rate(Heart rate will be measured in each subject within 28 days before and within 28 days after consuming either low or high polyphenol EVOO.)
研究者
Ralph Hamill
Cardiologist
MaineHealth