NCT01496235终止不适用
Randomized Clinical Trial of the Effect of Cocoa Consumption in Cardiovascular and Immune Parameters in Colombian Patients With Newly Diagnosed Stage 1 Arterial Hypertension
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Change in diastolic blood pressure
研究概览
简要总结
Arterial hypertension is one of the most preventable risk factors for stroke, cardiovascular and renal disease. Cocoa is rich in a subclass of flavonoid called flavanol this increase nitric oxide production and is involved in controlling blood pressure.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 - 65 years old
- •Resides in Medellín City
- •Attached from the contributive regimen of Colombian Health System
- •Essential Arterial Hypertension, stage I. Diagnosis less than 3 months.
- •Medically indicated non-pharmacological therapy.
- •Voluntary desire to consume 50 grams of chocolate per day for 12 weeks.
- •Voluntary desire to participate in the trial and sign informed consent.
排除标准
- •Suspect of secondary hypertension
- •Suspect of injury in target organ
- •Presence of diabetes mellitus
- •BMI (Body Mass Index) major or equal to 30
- •Present smoker or with less than four weeks of abstinence of tobacco
- •Consume antiplatelet substances
- •Regular consumption of antioxidants, multivitamins, anti-inflammatory medications, drugs for nasal congestion and sibutramine
结局指标
主要结局
Change in diastolic blood pressure
时间窗: Baseline and 12 weeks
Measurement of the diastolic blood pressure with the ambulatory blood pressure monitoring
次要结局
- Change in systolic blood pressure(Baseline and 12 weeks)
- Change in total cholesterol(Baseline and 12 weeks)
- Change in low density lipoprotein cholesterol(Baseline and 12 weeks)
- Change in high density lipoprotein cholesterol(Baseline and 12 weeks)
- Change in triglycerides levels(Baseline and 12 weeks)
- Change in hs-CRP(Baseline and 12 weeks)
- Change in IL-1 beta levels(Baseline and 12 weeks)
- Change in IL-2 levels(Baseline and 12 weeks)
- Change in tumor necrosis factor alpha levels(Baseline and 12 weeks)
- Change in flow mediated dilatation of the brachial artery(Baseline and 12 weeks)
研究者
Monica Lucia Giraldo
Principal Investigator
Universidad de Antioquia
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Acute Hemodynamic Effects of Cocoa Polyphenols in Subjects With Hypertension and Optimal Blood PressureHypertensionNCT00654862University of Cologne48
已完成
不适用
Controlled Clinical Trial to Determine the Effective Dose of Cocoa in Lowering Blood PressureHypertensionNCT01276951Universidad de Antioquia125
Unknown
2 期
Investigating the Use of Genetics to Guide Pharmacologic Therapy for HypertensionHypertensionNCT02988245Geneticure, LLC1,000
终止
不适用
WIreless Monitoring and Financial Incentives for Uncontrolled HYpertension (WIFHY) StudyHypertensionNCT03368417Duke-NUS Graduate Medical School42
已完成
1 期
Effects of Cocoa Intake on Blood Pressure in Elderly Individuals With Mild HypertensionHypertensionNCT00421499University of Cologne44