Efficacy of a Tomato Pomace Extract for Inhibiting Platelet Aggregation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 99
- 试验地点
- 2
- 主要终点
- Change from baseline platelet aggregation at three hours
研究概览
简要总结
This study evaluates the acute and longer term effects of a tomato pomace extract on platelet aggregation in health subjects.
详细描述
Evidence from human intervention trials and mechanistic studies suggests that tomato and tomato based products are associated with a reduction in CVD risk. The mechanism by which this protective effect occurs is not clearly understood but research has focused on its potential to modulate platelet function. This single-blind, randomized, parallel design human intervention trial will recruit 99 participants to consume an orange flavoured beverage containing different doses of a tomato pomace extract (1.0 and 2.5 g) or placebo control over a 5-day period. The study aims is to investigate the effects of consuming different doses of the tomato pomace extract on platelet aggregation. Safety and tolerability of the tomato pomace extracts was tested prior starting this study by undertaking a single ascending dose study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 26 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Apparently healthy men aged between 18 and 26 years
- •BMI >19.5 and <26.0
- •Platelet aggregation response corresponding to ≥ 65%
排除标准
- •Known tomato allergy
- •Chronic medical conditions requiring active treatment (e.g. cardiovascular disease, diabetes, asthma)
- •Gastro-intestinal disease/disorders
- •Medically prescribed medication known to affect platelet function
- •Self-prescribed medication known to affect platelet function (e.g. aspirin and non-steroidal anti-inflammatory drugs) unless participant is willing to give up.
- •Bleeding disorders (e.g. haemophilia)
- •Dietary supplements judged to affect study outcome
- •Parallel participation in another research project which involves dietary intervention
- •Blood donation within 16 weeks prior to the study
- •Depressed or elevated blood pressure measurements (<90/50 or 95/50 if symptomatic or ≥ 160/100 mmHg)
- •Any person related to or living with any member of the study team
结局指标
主要结局
Change from baseline platelet aggregation at three hours
时间窗: Blood samples on two separate occasions (baseline and three hours post-intervention)
次要结局
- Change from baseline platelet aggregation at 5 days(Blood samples on two separate occasions (baseline and 5 days post- intervention))