Effect of Cocoa Consumption in Cardiovascular and Immune Parameters
关键词
抽象
日期
| 最后验证: | 11/30/2011 |
| 首次提交: | 11/23/2011 |
| 提交的预估入学人数: | 12/15/2011 |
| 首次发布: | 12/20/2011 |
| 上次提交的更新: | 12/15/2011 |
| 最近更新发布: | 12/20/2011 |
| 实际学习开始日期: | 06/30/2009 |
| 预计主要完成日期: | 06/30/2011 |
| 预计完成日期: | 06/30/2011 |
状况或疾病
干预/治疗
Dietary Supplement: Dark chocolate
Dietary Supplement: White chocolate
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Active Comparator: Dark chocolate Presence of 70% cocoa solids | Dietary Supplement: Dark chocolate Each chocolate bar provided 210 calories represented in 25 grams of carbohydrates, 3 g of proteins, 18 g of total fat and the presence of 70% cocoa solids |
| Placebo Comparator: White chocolate | Dietary Supplement: White chocolate Each chocolate bar provided 230 calories represented in 28 grams of carbohydrates, 3 g of proteins, 18 g of total fat, without the presence of 70% cocoa solids |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - 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. Exclusion Criteria: - 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 |
结果
主要结果指标
1. Change in diastolic blood pressure [Baseline and 12 weeks]
次要成果指标
1. Change in systolic blood pressure [Baseline and 12 weeks]
2. Change in total cholesterol [Baseline and 12 weeks]
3. Change in low density lipoprotein cholesterol [Baseline and 12 weeks]
4. Change in high density lipoprotein cholesterol [Baseline and 12 weeks]
5. Change in triglycerides levels [Baseline and 12 weeks]
6. Change in hs-CRP [Baseline and 12 weeks]
7. Change in IL-1 beta levels [Baseline and 12 weeks]
8. Change in IL-2 levels [Baseline and 12 weeks]
9. Change in tumor necrosis factor alpha levels [Baseline and 12 weeks]
10. Change in flow mediated dilatation of the brachial artery [Baseline and 12 weeks]
