NCT01233024已完成早期 1 期
Satiety Response of Fructo-oligosaccharide (FOS), Inulin, Soluble Corn Fiber (SCF), and Resistant Starch (RS) in Overweight Woman and Relationship to Fermentation
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Satiety response using visual analogue scales
研究概览
简要总结
Studies have found a relationship between dietary fiber consumption and body weight regulation. This relationship may stem from enhanced satiety through fermentation of certain fibers in the large intestine.
The objective of this study is to determine and compare satiety ratings, changes in food intake, and gastrointestinal effects for four fibers: fructooligosaccharide, inulin, soluble corn fiber, and resistant starch.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy women
- •Age 18-40 years
- •Nonsmoking
- •Not taking weight loss medications
- •Non-dieting (weight has not changed more than 11 pounds over three months)
- •BMI between 18.5 and 29
- •Spoken and written English literacy
排除标准
- •Do not regularly consume breakfast
- •Food allergies to wheat, soy, peanut, or dairy
- •BMI less than 25 or greater than 29 upon admission to study
- •Cancer diagnosis in past 5 years
- •History of heart disease, kidney disease, diabetes, or eating disorder
- •History of ulcerative colitis, Crohn's disease, or any other gastrointestinal condition
- •History of drug or alcohol abuse in past 6 months
- •Use of lipid-lowering, anti-hypertensive, or anti-inflammatory steroid medication
- •Concurrent or recent (within 30 days) intervention study participation
- •Pregnant or lactating
- •Irregular menstrual cycle
- •Vegetarians
- •People who eat more than approximately 15 grams of fiber per day
结局指标
主要结局
Satiety response using visual analogue scales
时间窗: 0, 15, 30, 45, 60, 90, 120, 180 minutes postprandially
Satiety response will be measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS).
次要结局
- Food intake(180 minutes postprandially and over 24 hours)
- Breath hydrogen response(0 and 180 minutes)
- Gastrointestinal tolerance using visual analogue scales (VAS)(24 hours)
研究者
研究点 (2)
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