Efficacy of Dark Chocolate in Achalasia Patients: Placebo-Controlled Study
试验速览
- 阶段
- 1 期
- 入组人数
- 40
- 主要终点
- Lower Esophageal Sphincter relaxation before and after dark chocolate consumption.
研究概览
简要总结
Flavanols, present in dark chocolate, were shown to induce Nitric Oxide synthesis. Since Nitric Oxide facilitates smooth muscle relaxation, it might ease the relaxation of the LES (lower esophageal sphincter)as well.
The objective of the present study is to evaluate tha efficacy of dark chocolate in improving LES relaxation in achalasia patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of "achalasia"
- •"Achalasia" diagnosis during manometry at day 1 of the study.
排除标准
- •pregnancy
- •pseudoachalasia
- •consumption of GI-motility modifiers durin 72 hours preceding the study.
研究组 & 干预措施
1
dark chocolate consumption during manometry and 2 weeks treatment with dark chocolate
干预措施: dark chocolate (Dietary Supplement)
2
placebo comparator: 7 grams of placebo-chocolate at day 1 during manometry, and than crossover to treatment with dark chocolate for 2 weeks.
干预措施: placebo chocolate with crossover to dark chocolate (Dietary Supplement)
结局指标
主要结局
Lower Esophageal Sphincter relaxation before and after dark chocolate consumption.
时间窗: day 1
次要结局
- achalasia symptoms before and during dark-chocolate consumption(2 weeks)