Effects of Tomato Sauce on Endothelial Dysfunction Induced by a High Fat Meal in Healthy Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Flow Mediated Dilatation (FMD)
研究概览
简要总结
Several epidemiological and intervention studies suggest that a high dietary intake of tomatoes is associated with lower risk of cardiovascular disease (CVD), while, low intake is associated with an increased incidence of CVD. This beneficial effects have been attributed especially to lycopene, an antioxidant present in high concentration within tomatoes but other substances could be of importance.
Endothelial dysfunction is an early marker of atherosclerosis leading to CVD. The aim of the present study is therefore to investigate whether consumption of tomato products ameliorates peripheral endothelial function, triggered by a high fat meal, in human volunteers in a randomised, crossover dietary intervention study.
Study design:
Investigators are randomising healthy men (N=14-28) to consume a high fat meal either with or without tomato sauce (80 gr) in a cross-over design with a 7 days wash-out period. During the week before the study all the subjects will be maintained in a low fibers diet and only subjects randomized to tomatoes will receive a daily dose of 80 mg of tomato sauce (80 gr for 7 days= total load 560 mg).
We hypothesize that tomato sauce can improve the deleterious effects of a high fat meal on vascular function.
详细描述
Several epidemiological and intervention studies suggest that a high dietary intake of tomatoes is associated with lower risk of cardiovascular disease (CVD), while, low intake is associated with an increased incidence of CVD. This beneficial effects have been attributed especially to lycopene, an antioxidant present in high concentration within tomatoes but other substances could be of importance.
Endothelial dysfunction is an early marker of atherosclerosis leading to CVD. The aim of the present study is therefore to investigate whether consumption of tomato products ameliorates peripheral endothelial function, triggered by a high fat meal, in human volunteers in a randomised, crossover dietary intervention study.
Study design:
Investigators are randomising healthy men (N=14-28) to consume a high fat meal either with or without tomato sauce (80 gr) in a cross-over design with a 7 days wash-out period. During the week before the study all the subjects will be maintained in a low fibers diet and only subjects randomized to tomatoes will receive a daily dose of 80 mg of tomato sauce (80 gr for 7 days= total load 560 mg).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 38 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy men,
- •without overt risk factors for CVD (see
排除标准
- •age range 28 ±10 years;
- •BMI between 19-27 Kg/m2
- •Exclusion Criteria:
- •Previous cardiovascular events, kidney failure (serum creatinine ≥1,5 mg/dl), arterial blood pressure ≥140/90mmHg or diagnosed hypertension; chronic inflammatory or neoplastic diseases, diabetes mellitus or impaired fasting glucose (glucose ≥110 mg/dL), hypercholesterolemia (total cholesterol ≥240 mg/dl or anti-lipemic medication use), current smoking, antihypertensive medications; use of antioxidant drugs or NSAIDs or COXIBs; food allergy to tomato or other components of the high fat diet.
结局指标
主要结局
Flow Mediated Dilatation (FMD)
时间窗: change in FMD 2 and 3.5 hour after a high fat meal
Endothelial function as measured non-invasively by ultrasound (LogiQ P5 pro, GE Healthcare) using the "Flow Mediated Dilatation" (FMD) technique with the aid of a dedicated hardware (Multimedia Video Engine II (MVE2) DSP Lab., Pisa CNR, Italy).
次要结局
- Arterial stiffness measured as Stiffness Index (SI), Carotid distensibility (CD)(change in SI and CD 2 and 3.5 hour after a high fat meal)
- inflammatory cytokines(chnage in inflammatory cytokines 2 and 3.5 hour after a high fat meal)
- blood pressure(change in blood pressure 2 and 3.5 hour after a high fat mealeal)
研究者
Cristiano Fava
MD, PhD
Universita di Verona