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临床试验/NCT01796561
NCT01796561已完成不适用

Effect of Chronic Polyphenol-rich Olive Leaf Extract Intake on Cardiovascular Risk Markers

University of Reading1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2013年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Blood pressure measured via 24 hour ambulatory blood pressure monitors

研究概览

简要总结

Cardiovascular disease (CVD) is the leading cause of death in New Zealand (40% of all deaths). 37% of New Zealanders suffer from high blood pressure (World Health Organisation 2008 figures), a well established modifiable risk factor for CVD. Above 115/75 mmHg, CVD risk doubles for each increment of 20/10 mmHg that blood pressure is raised. An increase in BMI and waist circumference has been associated with an increase in blood pressure. The leaves of the olive plant are rich in plant compounds known as polyphenols. This particular group of polyphenols are known secoiridoids, which are also present in olive oil and olives though at lower concentrations, are only found in this family of plants. Diets high in polyphenols have been found to reduce the risk of chronic diseases. Studies have shown that consumption of phenolic-rich olive leaf extract (OLE) can significantly reduce blood pressure in individuals suffering from high blood pressure (hypertension), with the magnitude of effect being comparable to a commonly used antihypertensive drug. In such trials OLE also resulted in an improved blood lipid (a reduction in total and LDL cholesterol and triacylglycerides) which also reduces CVD risk. One study testing the effect of OLE on individuals with mild or prehypertension (i.e. those with systolic blood pressure in the range 121-139 mmHg and diastolic blood pressure in the range 81-89 mmHg but not taking antihypertensive medication) also found these same improvements. OLE has been indicated to have the potential to improve other cardiovascular risk markers such as vascular function, inflammation, platelet aggregation, oxidation of LDL and glucose tolerance however much of this evidence is derived from animal, in vitro and ex vivo studies and so well designed and controlled human studies are required to verify that these findings are applicable to humans. Therefore OLE supplementation may be a useful dietary strategy for reducing CVD risk in a cohort of overweight prehypertensive individuals.

The aim of the study is to determine the effect of OLE intake on blood pressure and other CVD risk markers in overweight subjects with mild hypertension and to link any study outcomes with the presence of OLE phenolics in urine

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
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 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •Men 18-65 years; Non-smokers; Prepared to consume olive leaf extract liquid Systolic blood pressure 121-139 mmHg and diastolic blood pressure 81-89 mmHg Body mass index (BMI) between 25-30 kg/m2 or waist >102 cm

排除标准

  • •Smokers Using blood pressure, lipid lowering, thyroid disorder, blood clotting medication Using supplements or functional foods that will affect lipid concentrations (e.g. sterol enriched spreads) Chronic disease e.g. CHD, diabetes, cancer, digestive disorders Individuals who are unwilling to refrain from consuming olive containing products for the duration of the study

研究组 & 干预措施

Olive leaf extract liquid

Active Comparator

20ml of polyphenol-rich olive leaf extract liquid to be consumed daily for 6 weeks

干预措施: Olive leaf extract liquid (Dietary Supplement)

Placebo liquid

Placebo Comparator

20ml of polyphenol-free placebo liquid (containing water, glycerin, flavours, colours and aromas) to be consumed daily for 6 weeks

结局指标

主要结局

Blood pressure measured via 24 hour ambulatory blood pressure monitors

时间窗: 6 weeks

次要结局

  • Insulin measured via plasma assay(6 weeks)
  • Obesity markers (adiponectin, CCL-2, complement factor D, CRP, IL-6, IL-10, leptin, resistin, serpin E1 and TNF-a) measured via plasma assay(6 weeks)
  • Nitric oxide measured via plasma assay(6 weeks)
  • Lipid profile measured via serum assay(6 weeks)
  • Inflammatory cytokines measured via plasma assay(6 weeks)
  • Glucose measured via plasma assay(6 weeks)
  • Vascular function assessed by pulse wave velocity (PWV)(6 weeks)
  • Fructosamine measured via plasma assay(6 weeks)
  • Haemostatic factors (D-dimer, PAI-1 ag, von Willebrand factor, prothrombin F1+2, factor VIII) measured via plasma assay(6 weeks)
  • Oxidised LDL measured via plasma assay(6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeremy Paul Edward Spencer

Professor of Biochemistry

University of Reading

研究点 (1)

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