NCT02868515已完成不适用
A Clinical Trial to Assess the Effect of Hot Cereal on Digestive Health in Children
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Self reported frequency scales to questionnaire regarding digestive regularity
研究概览
简要总结
The objective of this study is to examine the effects of 2 servings of hot cereal per day over 2 weeks on digestive health in children that typically eat low fiber diets.
详细描述
Participant eligibility will be screened at visit 1. The study will be a single-arm intervention design. The study procedures will include a pre-study visit, a pre-intervention baseline data collection period, a 14 day intervention period, and an end of study visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between the ages of 7-12 yrs.
- •Low fiber eater (<14 g/d)
- •Accustomed to eating breakfast at home
- •Demonstrates spoken and written English literacy
- •Parent/or legal guardian has experience using a cell phone camera
- •Parent/or legal guardian is capable of emailing and texting photos by using cell phone features that enable this such as the select and attach option
- •Able to provide assent with parent and/or legal guardian after review of study protocol and procedures
- •Parent and/or legal guardian will also be required to provide consent on behalf of the child after reviewing study protocol and procedures
排除标准
- •Use of enemas, laxatives, proton pump inhibitors, or antibiotics within the past 3 months
- •Use of fiber supplements such as fiber gummies (inulin/chicory root), or Metamucil or Citrucel
- •Use of vitamin/mineral supplements, multivitamins, or herbal supplements.
- •Participation in any other clinical trial up to 6 months before day 1 of participation in this study
- •History of medical or surgical events that may significantly affect the study outcomes including diagnosed gastric or digestive diseases
- •Not a regular breakfast eater at home
- •High-fiber eater (>14 g of fiber per day)
- •Allergies to any of the ingredients in the test products
- •Children taking medication that affects appetite (i.e. certain ADHD medications that depress appetite)
研究组 & 干预措施
Oatmeal containing beta-glucan
Experimental
43 g cereal containing 3g fiber per serving
干预措施: Hot cereal contain 3 g dietary fiber (Other)
结局指标
主要结局
Self reported frequency scales to questionnaire regarding digestive regularity
时间窗: 2 weeks
次要结局
- Gastrointestinal tolerance(2 weeks)
研究者
研究点 (2)
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