EVOO-coratina Intervention on Lipids in Non-diabetic Hypertensive (h) Patients With Hyperlipidemia (h) Undergoing Periodic Hemodialysis (h)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Serum levels of total cholesterol
研究概览
简要总结
Twenty-four non-diabetic hypertensive and hyperlipidemic patients undergoing periodic chronic hemodialysis will be enrolled for receiving extravirgin olive oil (EVOO) Coratina (12 patients) or refined olive oil (12 patients). Aim of the study is to evaluate the effect of EVOO-C on serum lipid levels. Randomization will be done centrally with appropriate stratification. Sample size is opportunistic because this is a pilot study. Dietary and clinical monitoring will be done by nephrologists, cardiologists and dieticians.
详细描述
Detailed Description: EXTRAVIRGIN OLIVE OIL CORATINA INTERVENTION ON LIPIDS IN NON-DIABETIC HYPERTENSIVE (H) PATIENTS WITH HYPERLIPIDEMIA (H)UNDERGOING PERIODIC HEMODIALYSIS (H) (EVOOC-3H) INTRODUCTION What is known. The primary causes of death in patients undergoing chronic hemodialysis (HD) are the cardiovascular events.
Cardiovascular risk factors(hypertension, type 2 diabetes, obesity, high levels of low density lipoprotein (LDL) , low levels of high density lipoprotein cholesterol (HDL), smoking and reduced physical activity) are almost universally present in people on HD. Evidence from randomized clinical trials demonstrate that statin administration in patients undergoing HD does not reduce the risk of adverse vascular outcomes. In the general population, there is growing evidence that the Mediterranean diet supplemented with olive oil implies cardiovascular and survival advantage. The favorable effects of the extravirgin olive oil (EVOO) are due to the combination of high content of monounsaturated fatty acids (MUFA) and polyphenols. The EVOO Coratina (EVOOC), produced in the Puglia Region within the Bari Province, is characterized by high values of polyphenols ranging between 400 and 1000 mg/kg of EVOO.
What is unknown. The potential effects of EVOOC in people on HD have not been formally explored both for surrogate and patient level endpoints.
Why this study. The investigators want to evaluate the effects of EVOOC in non-diabetic hypertensive patients undergoing chronic HD on a series of surrogate endpoints.
AIM OF THE PROPOSAL The investigators will investigate the effects of EVOOC with high content of polyphenols compared with refined olive oil (ROO) on lipid levels in HD patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The olive oils will be administered as oil A or B with content unknown to participants, investigators and outcome assessors
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The investigators will enroll non-diabetic hypertensive and hyperlipidemic patients undergoing chronic HD
- •Hypertension will be defined as having a systolic blood pressure of >130 mmHg and a diastolic blood pressure >80 mmHg or having any antihypertensive agents.
- •Hyperlipidemia will be defined as having LDL cholesterol values more than 100 mg/dl or receiving statins at any dose.
- •Eligible patients may be of any age.
排除标准
- •Diabetes mellitus type 1 or 2
- •Severe heart failure (NYHA class IV)
- •Patients with low compliance or severe psychiatric illnesses
- •Smoking, intake of antioxidant supplements (eg, carotenoids, vitamin C, vitamin E and glutathione), aspirin, or any other drug with established antioxidant properties, hyperlipidemia, obesity (body mass index >30 kg/m2), diabetes, celiac or other intestinal disease, life-threatening
- •Survival expectancy <6 months based on managing physicians assessment
- •Inability to participate in the trial based on managing physicians assessment
结局指标
主要结局
Serum levels of total cholesterol
时间窗: 3rd month
Blood measurement
Serum levels of HDL cholesterol,
时间窗: 3rd month
Blood measurement
Serum levels of LDL cholesterol
时间窗: 3rd month
Blood measurement
次要结局
- number of participants with myocardial infarction(Measurement will be done at 3rd month)
- number of participants with high blood pressure(3rd month)
研究者
Francesco Paolo Schena
President and scientif director
Fondazione Schena