Absorption and Metabolism of Olive Leaf Extract and Its Effect on Vascular Reactivity and Cytokine Concentrations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Absorption and metabolism
研究概览
简要总结
The purpose of this study is to determine how olive leaf is absorbed and metabolised and also whether it has any effect on the elasticity of blood vessels and the immune system.
详细描述
The purpose of this study is to determine how olive leaf is absorbed and metabolised and also whether it has any effect on vascular function and cytokine concentrations.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •19-40 years, non-smokers, able to swallow capsules, have a Body Mass Index (BMI) of 18.5-30, have a normal liver function and haematology and a max alcohol intake of <21 units/week
排除标准
- •Those who suffer from any form of disease, including endocrine disease, liver disease, diabetes mellitus, myocardial infarction, blood clotting disorder, reproductive disorder, gastrointestinal disease or a chronic gastrointestinal disorder.
- •Individuals who are vegetarian, have dietary restrictions or on a weight reducing diet will not be recruited.
- •Subjects who have been taking antibiotics in previous 3 months before study will not be included in the study
- •Females who may be pregnant, or if of childbearing potential and are not using effective contraceptive precautions will be excluded.
- •Blood pressure > 150/90 mmHg
- •Haemoglobin < 125 g/l for male, < 110 g/l for female
- •Gamma GT (liver enzymes) > 80 IU/l
- •Cholesterol > 6.5 mmol/l
- •Had suffered a myocardial infarction or stroke in the previous 12 months
- •On any lipid-modifying medication
- •On any medication affecting blood clotting
- •Individuals taking vitamin and/or fish oil supplements
研究组 & 干预措施
Placebo capsule
Four placebo capsules containing safflower oil only
干预措施: Olive leaf extract capsules (Dietary Supplement)
Olive leaf extract capsule
Four olive leaf capsules. Each containing 4mg oleuropein plus safflower oil.
干预措施: Olive leaf extract capsules (Dietary Supplement)
结局指标
主要结局
Absorption and metabolism
时间窗: 0. 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post ingestion (blood) 0, 0-4, 4-8 and 8-24 hours post ingestion (urine)
Olive leaf polyphenol metabolites measured in blood and urine samples
次要结局
- Vascular function(0, 2, 4, 6 hours post ingestion (LDI) 0, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hours post ingestion (DVP))
- Cytokine concentration(0, 1, 3 and 6 hours post ingestion)
研究者
Jeremy Paul Edward Spencer
Professor of Biochemistry
University of Reading