Laxation and Satiety Response of Novel Dietary Fibers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Whole gut transit time determined by radio-opaque pellets
研究概览
简要总结
Dietary fibers have previously been shown to affect laxation and satiety. Due to differences in structure and physical properties of dietary fibers, these effects may not be consistent across all fibers. Therefore as new dietary fibers are created or discovered the laxative and satiating effects should be investigated in order to verify these effects.
详细描述
This study was designed to test the laxative effects of two fibers a resistant starch made from corn and a glucose polymer fiber. The secondary aim of this study was to examine the satieting effects of these fibers. This trial was double-blind and placebo controlled. On the first day of the study subjects consumed the breakfast cereal and milk and were instructed to complete visual analog scales periodically to test acute satiety. Subjects also completed diet records and tolerance questionnaires on days 1,2, and 10. Additionally subjects completed another satiety survey on day 10 to test chronic satiety. Whole gut transit time, fecal weight, and fecal chemistry was tested by swallowing radioopaque pellets on day 6 and collecting every fecal sample for the 5 days thereafter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy men and women
- •age 18-65
- •non-smoking
- •not taking medication
- •non-dieting (weight stable in prior 3 months)
- •BMI 18-30
- •English literacy
排除标准
- •do not regularly consume breakfast
- •food allergies to ingredients found in study product
- •dislike of cereal or muffins
- •BMI <18 or >30
- •diagnosed with cardiovascular, renal, or hepatic disease
- •diabetes mellitus (fasting blood glucose > 126 mg/ml)
- •cancer in previous 5 years (except basal cell carcinoma of the skin)
- •any gastrointestinal disease or condition
- •recent bacterial infection (< 3 months)
- •recent or concurrent participation in an intervention research study
- •history of drug or alcohol abuse in prior 6 months
- •use of lipid-lowering, anti-hypertensive, or anti-inflammatory steroid medications vegetarians people who eat more than approximately 15 grams of dietary fiber per day women who are pregnant or lactating women with irregular menstrual cycles consumption of prebiotics or probiotics
结局指标
主要结局
Whole gut transit time determined by radio-opaque pellets
时间窗: 5 day fecal collection
Determine whole gut transit time by x-raying fecal samples after swallowing radio-opaque pellets
次要结局
- Satiety(0, 15, 30, 45, 60, 90, 120, 180, 240 minutes postprandially)
- Breath Hydrogen concentration after consumption of test cereal(0 and 240 minutes postprandially)
- Ad libitum food intake(24 hours, 48 hours, and 10 days after the start of treatment)
- Gastrointestinal Tolerance(24 hours, 48 hours, and 10 days after the start of the treatment)
- Fecal chemistry(6-10 days after the start of treatments)