NCT00937742已完成不适用
The Effect of Processed Tomatoes on Endothelium- and Platelet- Function
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
- 32
- 试验地点
- 1
- 主要终点
- Vascular function
研究概览
简要总结
The primary working hypothesis is that consuming processed tomatoes frequently/daily will favorably improve endothelium and platelet function disease-risk biomarker profiles in adult men and women compared to consuming no or relatively low amounts of processed tomatoes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •men and women (>21 <70 years) nonsmokers, with a body mass index (BMI) ranging of 25 to 35 kg/m2, BP < or = 140/90 mmHg
排除标准
- •Total cholesterol (TC) is greater than 300 mg/dL;
- •Fasting triglyceride is greater than 300 mg/dL;
- •LDL cholesterol (LDL-C) is greater than 180 mg/dL;
- •Female subjects who are pregnant or lactating;
- •Subjects who are actively losing weight or trying to lose weight;
- •Subjects with known allergy or intolerance to tomato products;
- •taking any medications that would interfere with outcomes of the study, ie. lipid lowering medications, anti-inflammatory drugs, dietary supplements, such as fish oil or evening primrose;
- •subjects' with documented atherosclerotic disease, inflammatory disease, diabetes mellitus, uncontrolled hypertension (>=140/90 mm Hg - ok if controlled below this limit with medication), or other systemic diseases;
- •subjects with low hematological counts as determined by >or <15% the upper or lower cut-off values of normal established for the lab;
研究组 & 干预措施
Non-tomato products
Experimental
Non-tomato products (i.e. teriyaki marinade, sprite, applesauce) to be consumed daily in replace of tomato products
干预措施: Tomato products (Dietary Supplement)
结局指标
主要结局
Vascular function
时间窗: Baseline and end of intervention phase (week 6)
Platelet and monocyte function/activity
时间窗: Baseline and end of intervention phase (week 6)
次要结局
- Lipids(Baseline and end of intervention phase (week 6))
- Insulin/Glucose(Baseline and end of intervention phase (week 6))
- Inflammatory Markers(Baseline and end of intervention phase (week 6))
研究者
研究点 (1)
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