Effect of Different Doses of Tomato Lycopene on the Blood Pressure in Prehypertensives and Grade I Never Treated Otherwise Healthy Subjects
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Blood Pressure
研究概览
简要总结
Effect of different doses of tomato extract (contain Lyc-o-Mato 6% Oleoresin which Contain: 5, 15 mg lycopene , in addition to Beta-carotene (0.15%), phytoene, and phytofluene (1%); and vitamin E (2%), phospholipids (15%), and phytosterols (0.6%) suspended in tomato oleoresin oil) compared with synthetic lycopene on blood pressure and plasma lycopene levels in never treated pre-hypertensive otherwise healthy subjects.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 35 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 35-60,
- •No antihypertensive treatment in the past or present,
- •135< SBP< 145 or 85<DBP<95,
- •Informed consent signed,
排除标准
- •Unwilling to participate in the study,
- •Treated essential,
- •secondary or complicated hypertension,
- •SBP lower than 135 or higher than 145 mmHg,
- •DBP lower than 85 or higher than 95 mmHg,
- •Use of other medications (statins, NSAI ect..),
- •Known allergy to tomato, carotenoids, or vitamin E,
- •Diabetes Mellitus,
- •Obesity BMI>32,
- •Significant dyslipidemia,
- •Patients with ischemic pain, S/P MI, PTCA or CABG, LVH or CHF,
- •Valvular heart disease,
- •Cerebrovascular disease, s/p CVA, TIA,
- •Any kind of kidney disease (creatinine>1.6),
- •Chronic liver disease(elevated AST and ALT at least by 2 times of the normal range),
- •Alcohol abuse,
- •History of GI disease or surgery,
- •History of malignancy in the past 5 years,
- •History of autoimmune disease,
- •Participation in other researches protocol
研究组 & 干预措施
1
干预措施: Placebo (Other)
2
Lyc-o-Mato 5mg
干预措施: Lyc-O-Mato 5mg (Dietary Supplement)
3
Lyc-o-Mato 15mg
干预措施: Lyc-O-Mato 15mg (Dietary Supplement)
4
Lyc-o-Mato 30mg
干预措施: Lyc-O-Mato 30mg (Dietary Supplement)
5
Lycopene capsules (non Lyc-o-mato) 15 mg
干预措施: Lycopene capsules (non Lyc-o-mato) 15 mg (Dietary Supplement)
结局指标
主要结局
Blood Pressure
时间窗: Every 2 weeks (Overall 12 weeks )
次要结局
- Serum nitrite-nitrate levels(Week 0,Week 12)
- Serum lycopene levels(Week 0,Week 12)
- Serum Phytofluene levels(Week 0,Week 12)
- Serum 8 isoprostane levels(Week 0,Week 12)