Effects of Dark vs. White Chocolate on the Postprandial Increase in Portal Pressure in Cirrhosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Postprandial change in HVPG (% change and absolute change in mmHg)
研究概览
简要总结
This study was aimed at testing the hypothesis that supplementing a meal with dark chocolate, which holds potent antioxidant properties, might attenuate the postprandial increase in the hepatic venous pressure gradient (HVPG, clinical equivalent of portal pressure) in patients with cirrhosis
详细描述
Previous studies showed that the intrahepatic circulation in cirrhosis is not able to adapt to sudden increases in blood flow, such as that occurring after a meal, due to endothelial dysfunction. This leads to a brisk increase in portal pressure (estimated by the HVPG). This method is therefore useful to assess the efficacy of compounds potentially ameliorating intrahepatic endothelial dysfunction. Dark chocolate, which contains a high proportion of cocoa flavonoids such as cathechin and epicatechin- powerful antioxidants, increases NO availability in the systemic circulation and improves systemic endothelial function. We hypothesised that the antioxidant properties of dark chocolate could be beneficial in patients with cirrhosis, since they might improve intrahepatic endothelial dysfunction. Consequently, the aim of this study was to evaluate whether a dark chocolate-containing test meal may attenuate the post-prandial increase in HVPG in patients with cirrhosis and portal hypertension.
HVPG was measured at baseline and 30 minutes after the administration of a test meal supplemented by either dark or white chocolate. Portal vein blood flow and hepatic artery blood flow were measured by Doppler ultrasound. Catechins and NOx were determined for both timepoints.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age over 18 years
- •diagnosis of cirrhosis (proven by biopsy or clinical, laboratory and imaging procedures)
- •presence of esophageal varices of any grade
- •HVPG ≥ 10 mmHg during the hemodynamic study
排除标准
- •food allergy to chocolate
- •ongoing treatment with ascorbic acid and/or other antioxidants
- •diffuse or multinodular hepatocellular carcinoma
- •advanced hepatic failure (defined as prothrombin ratio < 40% and bilirubin > 5 mg/dL)
- •renal failure (defined by a serum creatinine level > 1.5 mg/dL)
- •portal vein thrombosis
- •cardiac or respiratory failure
- •previous surgical or transjugular intrahepatic portosystemic shunt
研究组 & 干预措施
DarkChocolate
11 patients were randomized to receiving dark chocolate 0.55 g/kg of body weight (Lindt Excellence 85% Cocoa, Lindt & Sprüngli España) together with the test meal
干预措施: DarkChocolate (Dietary Supplement)
White chocolate supplementation
11 patients received 0.63 g/kg white chocolate (Lindt Excellence Natural Vanilla, Lindt & Sprüngli España) in an iso-caloric and iso-volumetric proportion adjusted to body weight.
干预措施: WhiteChocolate (Dietary Supplement)
结局指标
主要结局
Postprandial change in HVPG (% change and absolute change in mmHg)
时间窗: 30 minutes
次要结局
- Post-prandial change in portal vein blood flow by US-Doppler(30 minutes)
- Post-prandial change in nitric oxide metabolites(30 minutes)
- Post-prandial changes in catechin and epicatechin(30 minutes)
- Post-prandial changes in mean arterial pressure(30 minutes)