Comparison of Brown Rice Based-meal or Polished Rice Based-meal or Wheat Based-meal on Functional Constipation in Young Korean Women: A Opened, Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Total colon transit time
研究概览
简要总结
This study was conducted to investigate the effects of rice based-meal on functional constipation in young Korean women.
详细描述
Studies comparing and evaluating the effects of a rice-based diet and a wheat-based diet on bowel movements are insufficient. In summary, efficient measures are needed to help individuals consume enough dietary fiber from natural sources in daily life to improve their bowel movements, rather than to consume a fiber supplements separated or synthesized from a particular natural food. In this study, investigators compare and evaluate the effects and safety of eating rice-based diets (brown rice-based and white rice-based) and a wheat-based diet in terms of bowel health and bowel movements among young women with functional constipation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age of 19 to 30 years females
- •Meet of Rome Ⅲ diagnostic criteria of functional constipation
- •Ability to give informed consent
排除标准
- •Subject with a history or evidence of clinically significant gastrointestinal, anorectal, hepatic, renal, neurological, pulmonary, endocrine, blood tumor, psychiatric, cardiovascular disease
- •Subjects who have a gastrointestinal (GI) disease (Crohn's disease, etc.) that would increase the influence with absorbance medication or a GI surgery excluding appendectomy and hernia surgery
- •Known history of moderate to severe hepatic impairment (i.e., serum ALT>1.5×ULN, AST>1.5×ULN)
- •Subjects with significant hypersensitivity about brown rice, polished rice, wheat, milk
- •Regular ingestion of probiotic products
- •Subjects who received certain medications that cause the alteration of bowel movement within the past 2weeks prior to first administration
- •Subjects who participated in other clinical investigation within 2 months prior to first administration
- •Subject who drink constantly (21 units/week over)
- •Subject who are pregnant or breast feeding
- •Subject who have irritable bowel syndrome by ROME Ⅲ criteria
- •Any significant condition that, in the opinion of the investigator, could interfere with the subject's participation or compliance in the study(i.e., laboratory test and others)
结局指标
主要结局
Total colon transit time
时间窗: 0, 28 days from the start of the study
Hour of total colonic transit
次要结局
- Fecal propionic acid(0, 28 days from the start of the study)
- Fecal weight(0, 28 days from the start of the study)
- Fecal butyric acid(0, 28 days from the start of the study)
- Stool frequency(0, 28 days from the start of the study)
- Fecal urease(0, 28 days from the start of the study)
- Fecal β-glucosidase(0, 28 days from the start of the study)
- Fecal pH(0, 28 days from the start of the study)
- Fecal β-glucuronidase(0, 28 days from the start of the study)
- Fecal lactic acid(0, 28 days from the start of the study)
- Bowel movement(28 days from the start of the study)
研究者
Soo-Wan Chae
Clinical Trial Center for Functional Foods
Chonbuk National University Hospital