Efficacy of Pea Hull Fiber Supplementation on Gastrointestinal Transit in Overweight Children.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Change in Modified Bristol Stool Form score
研究概览
简要总结
The purpose of this randomized, cross-over study is to explore the effects of pea hull fiber on bowel movement frequency, transit time, appetite, gastrointestinal symptoms, microbiota composition and activity.
详细描述
An 8-week randomized, cross-over study will be carried out to assess the efficacy of pea hull fiber. Participants will complete a 2-week baseline period during which appetite, stool frequency, and stool consistency (transit time) will be collected by an online questionnaire, and participants will collect a single stool. Dietary data (Automated Self-Administered 24-Hour diet recall) will be obtained at baseline and at each study visit. Participants will be randomized on or about day 15 and consume snacks without pea hull fiber for a 2-week control period, and snacks with added pea hull fiber for a 2-week treatment period separated by a 2-week washout period. In both intervention periods, participants will complete daily questionnaires to assess stool frequency and consistency (transit time). An online questionnaire assessing appetite will be administered once per week. The GSRS will be competed at each study visit. During washout periods, the same data will be collected as will be done during the baseline and intervention periods. Participants will be asked to collect one stool during baseline and during weeks 4, 6, and 8 for a total of 4 stools. Stool samples will be analyzed for changes in the microbiota.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are willing to have height and weight measured and provide demographic information (e.g. age, race, sex).
- •Children age between 8-15 years old.
- •Are occasionally constipated.
- •Are willing to consume pea hull fiber and control snacks daily each for a 2-week period
- •Are willing to complete a daily questionnaire throughout the entire 8-week study.
- •Are willing to complete the appetite questionnaire two times per week.
- •Are willing to complete the Gastrointestinal Symptom Rating Scale (GSRS) bi-weekly.
- •Are willing to be interviewed for Automated Self-Administered 24-Hour-Kids-2014 (ASA24-Kids-2014) one time per 2-week period throughout the study.
- •Are willing and be able to provide a valid social security for study payment purposes.
排除标准
- •Have any known food allergies.
- •Are currently taking medications for diarrhea.
- •Have taken antibiotics within the past four weeks prior to randomization.
- •Have ≥ 6 bowel movements per week
- •Are currently taking probiotics supplements and do not want to discontinue a minimum of two weeks prior to the study.
- •Have previously or are currently being treated for any gastrointestinal diseases such as (gastric ulcers, Crohn's, Celiac, ulcerative colitis, etc.).
研究组 & 干预措施
Pea Fiber
Snacks fortified with 10 g of pea hull fiber will be administered for two weeks, followed by a two-week washout, and a two-week period with control snacks.
干预措施: Pea Fiber (Dietary Supplement)
Control
Control snacks will provided for 2 weeks, followed by a two-week washout, and snacks with 10 g/d of pea fiber for 2 weeks.
干预措施: Control (Dietary Supplement)
结局指标
主要结局
Change in Modified Bristol Stool Form score
时间窗: Change from baseline at weeks 4, 6 and 8
Stool consistency rating by Modified Bristol Stool Form for children
次要结局
- Change in number of bowel movements per week(Change from baseline at weeks 4, 6 and 8)