Effects of Swiss Dark Chocolate on Endothelial and Baroreceptor Function and Markers of Inflammation in Patients With Chronic Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- endothelial function
研究概览
简要总结
The aim of the present study is to investigate whether in patients with chronic heart failure endothelial dysfunction and baroreceptor function is altered by ingestion of a flavonoid-rich dark chocolate in comparison to placebo chocolate (Nestlé Placebo Chocolate) on top of standard medication.
Moreover, we will evaluate the effect of chocolate on oxidative stress, platelet adhesion as well as systemic inflammatory response such as C-reactive protein and pro-inflammatory cytokines in patients with chronic heart failure.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Heart failure ( NYHA ≥II, LVEF<50%, independent of aetiology)
- •Written obtained informed consent
排除标准
- •Decompensated Heart failure
- •Instable Angina pectoris
- •Ventricular tachyarrhythmias or AV-Block >I°
- •Renal failure (>200 umol)
- •Liver disease (ALT or AST >150 IU)
- •Diabetes mellitus
- •Obesity (BMI >30 kg/m2)
- •Symptomatic hypotension, hypertension >160/100mmHg
- •Known allergy to compounds of Nestlé noir intense
- •History of gastric ulcer or bleeding, current diarrhea
- •Venous thrombosis or pulmonary embolism, at present or recurrent history of Infectious disease, acutely or chronic
- •Disease with systemic inflammation (e.g. rheumatoid arthritis, M. Crohn)
- •Neoplasia (unless healed or remission >5 years)
- •Participation in another study within the last month
- •Concomitant vitamin supplements
研究组 & 干预措施
1
daily intake of 40gr chocolate (Nestlé Noir intense) in the morning and 40gr chocolate in the evening.
干预措施: Nestlé Noir intense 40 grx2 (Dietary Supplement)
2
Nestlé Placebo Chocolate 40gr in the morning and 40gr chocolate in the evening.
干预措施: Nestlé Placebo Chocolate 40 grx2 (Dietary Supplement)
结局指标
主要结局
endothelial function
时间窗: acute (2 hours), chronic (2 and 4 weeks)
次要结局
- shear-stress dependent platelet function; Oxidative stress; baroreceptor function Systemic inflammatory response (assessed as change in high sensitivity CRP, 8-Isoprostanes, CD-40 ligand); Plasma epicatechins.(acute (2 hours), chronic (2 and 4 weeks))