Effect of the Intake of a Tomato Sofrito Preparation on Biomarkers of Cardiovascular Disease in an Overweight and/or Obese Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Changes from baseline of platelet aggregation (induced by different agonists: arachidonic acid [1 mM], collagen [2 and 5 µM] and ADP [5 and 20 µM] at day 42
研究概览
简要总结
The study is a prospective, controlled, randomized two-arm longitudinal crossover trial, performed in a single-centre. Hence, the investigators designed a clinical study aimed to investigate the effects of a daily intake of soffritto in overweight or obese class-1 individuals without other cardiovascular risk. After a run-in period of two-week, participants were randomly separated in two different intervention sequences (two-arms) of six-weeks in which volunteers were administered with a soffritto (100 g/day) or a control group (without soffritto). After the first six-week period, participants had a wash-out phase of two-week followed by a second six-week period in which groups exchanged their interventions. During the duration of the study, the volunteers were asked to maintain their usual diet, excluding raw or cooked tomatoes, as well as tomato-based products (sauces, ketchup, juices, etc.) other than those administered during the study in the corresponding periods.
详细描述
Sample size (N= 40) was calculated according results of previous studies on pigs (http://dx.doi.org/10.1016/j.trsl.2014.11.004). The study refers to healthy adult men (n=27) and women (n=13) with ages ranging from 25 to 60 years, non-smokers and with overweight (BMI: 25.0-29.9 kg/m2) or obesity class 1 (BMI: 30-34.9 kg/m2).
This study received approval from the Human Ethical Review Committee of Hospital Santa Creu I Sant Pau (Barcelona), with the reference number 12/181 and the date of approval being January 11, 2013. To confirm health status, all subjects underwent a complete physical examination conducted by the study physician.
The study lasted 16 weeks that were structured in:
- 2 weeks of run-in.
- 6 weeks of intervention period. During the intervention period, volunteers were administered with soffritto (100 g/day) or a control group (without soffritto).
- 2 weeks of wash-out.
- 6 weeks of intervention period. During the intervention period, volunteers exchanged their interventions
The volunteers visited the center at days 0, 14, 56, 70 and at the end of the intervention period (day 112).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and Women 25-60 years of age
- •BMI: >28 Kg/m2
排除标准
- •Ischemic heart disease (and/or previous angina or AMI)
- •Less than 25 years old and more than 60 years old
- •Current/previous history of arrhythmia
- •Cardiovascular co-morbidity (previous cardiovascular accidents and/or peripheral vascular disease)
- •On current treatment with vasoactive drugs, fibrates or statins (see exception)
- •Alcohol consumption of more than 60 gr/day
- •Renal insufficiency (creatinine > 2 mg/dl)
- •Presence of neoplasia
- •Presence of systemic disease
- •Psychiatric disease in treatment with psychotropic drugs
- •Secondary dyslipidemia (nephrotic syndrome, hypothyroidism, others...)
- •Being in a weight loss phase or expressing a desire for weight loss during the 3 months of the study duration.
- •Having taken aspirin in the 10-day period prior to blood sampling.
结局指标
主要结局
Changes from baseline of platelet aggregation (induced by different agonists: arachidonic acid [1 mM], collagen [2 and 5 µM] and ADP [5 and 20 µM] at day 42
时间窗: At days 0 and 42
By the light transmission technique LTA. For all agonist results were expressed as the percentage of variation respect to the baseline value (100%).
次要结局
- Changes from baseline of standard serum lipid profile (total cholesterol, high density lipoprotein-cholesterol, low density lipoprotein-cholesterol and triacylglycerols expressed as mg/dL) at day 42(At days 0 and 42)
- Changes from baseline of hemogram profile at day 42(At days 0 and 42)
- Changes from baseline of hemodynamic profile at day 42(At days 0 and 42)
- Changes from baseline of hepatic enzymes (ALT, AST and GGT) at day 42(At days 0 and 42)
- Changes from baseline of glucose levels at day 42(At days 0 and 42)
- Changes from baseline of vascular endothelial function (RHI, lnRHI, FRHI and AI@75) at day 42(At days 0 and 42)
- Changes from baseline of renal markers (creatinine, urea and uric acid) at day 42(At days 0 and 42)
- Changes from baseline of BMI at day 42(At days 0 and 42)