NCT00795834Unknown不适用
Pilot Study to Assess Effects of Novel Beverages on Established and Novel Risk Markers for Vascular Disease
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Vascular Function (measured by Laser Doppler Iontophoresis and Pulse Wave Analysis / Pulse Wave Velocity)
研究概览
简要总结
The purpose of this study is to assess the effects of a novel beverage rich in polyphenols (compounds present in fruit extracts) on risk factors associated with cardiovascular disease.
详细描述
This study will assess the potential of a beverage containing plant and fruit extracts rich in polyphenolics to modulate vascular risk.
Novel risk factors for vascular disease will be assessed including non-invasive assessment of vascular function by pulse wave analysis / pulse wave velocity and laser doppler iontophoresis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age >/= 55 years
- •BMI > 25
排除标准
- •Present smoker or smoked within the last 2 years
- •HBA1C > 6.0%
- •LFT >/= 3 times upper limit of normal
- •Hypertension: systolic blood pressure > 160mmHg; diastolic blood pressure > 90mmHg, or on medication for hypertension.
- •Chronic disease, likely to be clinically relevant (eg:
- •cardiorespiratory, rheumatological, cerebrovascular or neoplastic disease)
- •Vitamin supplements within the previous 14 days
- •Medications which, in the opinion of the investigators, are known to influence vascular function (eg corticosteroids).
研究组 & 干预措施
Beverage
Placebo Comparator
干预措施: Placebo Beverage (Dietary Supplement)
High Polyphenol Beverage
Active Comparator
干预措施: High polyphenol beverage (Dietary Supplement)
结局指标
主要结局
Vascular Function (measured by Laser Doppler Iontophoresis and Pulse Wave Analysis / Pulse Wave Velocity)
时间窗: Baseline and post intervention
次要结局
- Established and novel blood markers for vascular disease(baseline and post intervention)
研究者
研究点 (1)
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