Are the Cardiovascular Responses of Individuals at Mild to Moderate Cardiovascular Risk Influenced by Dietary Flavonoid Sub-class and Dietary Form?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Change from baseline in blood vessel control (pressure and endothelial function) at time points coinciding with postprandial [anticipated] peak plasma flavonoid concentration.
研究概览
简要总结
The primary aim of this placebo-controlled study is to determine whether flavonoids beneficially affect markers of cardiovascular disease risk in healthy subjects at elevated cardiovascular risk.
The underlying mechanisms of action of flavonoids will be assessed on blood biomarkers and we will assess the effects of the food matrix, and aspects of isoflavone metabolism.
详细描述
The study population will be healthy males (aged 50-75 years) at elevated risk of cardiovascular (CV) disease.
A target of 60 participants will be required to complete the study and a total of 70 subjects will be targeted (n=70 subjects * ~85% anticipated completion rate = 60 subjects to complete the study).
This placebo-controlled study will test the relative efficacy of 4 different flavonoid sub-classes ((i) flavan-3-ol, (ii) anthocyanin, (iii) flavanone and (iv) isoflavone).
Accordingly, subjects will be randomised to one of the four flavonoid study groups ((i) to (iv) outlined above), and then will consume each of the following treatments in random order:
- dietary flavonoid + placebo supplement
- placebo food + commercially available/produced flavonoid supplement
- placebo food + placebo supplement
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •50 to 75 years old
- •At elevated risk of CV disease
- •Screening blood pressure of < 160/90mmHg (at rest)
- •Successful biochemical, haematological and urinalysis assessment at screening (as judged by clinical advisor)
排除标准
- •Current smokers, or ex-smokers ceasing < 3 months ago
- •Subjects with existing or significant past medical history of vascular disease or medical conditions likely to affect the study measures (as judged by clinical advisor)
- •Those with known allergies to the intervention treatments
- •Those unprepared to adhere to dietary restrictions during the trial
- •Parallel participation in another research project which involves concurrent dietary intervention and/or sampling of biological fluids/material
- •Having vaccinations (excluding the flu vaccination) or antibiotics within 3 months of start of trial, and those with vaccinations scheduled for during the trial
- •Taking flavonoid containing food / dietary supplements likely to affect the study results
- •Prescribed lipid lowering, hypertension, vasodilators (e.g. Viagra) or antibiotic medication
- •Unsatisfactory biochemical, haematological or urinary assessment at screening, indicating abnormal; renal or liver function, full blood profile, impaired glucose handling, deranged lipids or measurements considered to be counter indicative of the study by the clinical advisor
结局指标
主要结局
Change from baseline in blood vessel control (pressure and endothelial function) at time points coinciding with postprandial [anticipated] peak plasma flavonoid concentration.
时间窗: acute postprandial; up to 24 hours, dependent on flavonoid sub-classification studied
Assessment of vascular function
次要结局
- Differences in effects of flavonoids introduced by food matrix(acute postprandial; up to 24 hours dependent on flavonoid sub-classification studied)