NCT01073969已完成4 期
A Double-blind, Randomized, Controlled Crossover Trial to Assess the Digestive and Physiological Effects of a Wheat Bran Extract in Healthy Men and Women
Kellogg Company2 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2009年3月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- The primary outcome variable will be the difference between treatments in bifidobacteria counts per g of feces, expressed as log10 cells per g feces (dry weight)
研究概览
简要总结
The primary objective of this trial is to determine whether two doses of an extract from bran demonstrate a prebiotic effect on colonic bacteria (by modulating selected fecal microbial populations, particularly bifidobacteria). The secondary objective is to measure the potential beneficial effects of consuming an extract from bran on the following physiological parameters: laxation, fecal pH, fecal moisture and stool consistency, blood glucose and insulin concentrations, plasma lipid profiles and serum free fatty acids, colonic bacterial short chain fatty acid production, ammonia metabolism and protein degradation, and biomarkers of oxidative stress and inflammation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female
- •18-75 years of age
- •Body mass index ≥18.5 and <35.0 kg/m2
- •Fasting LDL-C level ≥100 mg/dL and <200 mg/dL
- •Otherwise judged to be in good health, willing to maintain habitual food and beverage intake and physical activity patterns throughout the trial
排除标准
- •Significant gastrointestinal condition
- •Use of pre/probiotic foods or supplements
- •Use of antibiotics
- •Pregnancy
- •Certain muscle, liver, kidney, lung or gastrointestinal conditions and medications
- •Poorly controlled hypertension
- •Cancer treated within prior 2 years
结局指标
主要结局
The primary outcome variable will be the difference between treatments in bifidobacteria counts per g of feces, expressed as log10 cells per g feces (dry weight)
时间窗: Baseline to end of each treatment (week 0 to week 3 of each treatment)
次要结局
- Other fecal bacterial counts(baseline to end of each treatment (week 0 to week 3 of each treatment))
- laxation(baseline to end of each treatment (week 0 to week 3 of each treatment))
- fecal pH(baseline to end of each treatment (week 0 to week 3 of each treatment))
- fecal moisture(baseline to end of each treatment (week 0 to week 3 of each treatment))
- stool consistency(baseline to end of each treatment (week 0 to week 3 of each treatment))
- blood glucose(baseline to end of each treatment (week 0 to week 3 of each treatment))
- Blood insulin(baseline to end of each treatment (week 0 to week 3 of each treatment))
- plasma lipid profiles(baseline to end of each treatment (week 0 to week 3 of each treatment))
- serum free fatty acids(baseline to end of each treatment (week 0 to week 3 of each treatment))
- fecal short chain fatty acids(baseline to end of each treatment (week 0 to week 3 of each treatment))
- fecal ammonia(baseline to end of each treament (week 0 to week 3 of each treatment))
- urinary para-cresol(baseline to end of each treatment (week 0 to week 3 of each treatment))
- urinary phenol (total)(baseline to end of each treatment (week 0 to week 3 of each treatment))
- urinary isoprostanes(baseline to end of each treatment (week 0 to week 3 of each treatment))
- oxidized low density lipoprotein (TBARS, conjugated dienes)(baseline to end of each treatment (week 0 to week 3 of each treatment))
- Urinary F2alpha-isoprostanes(baseline to end of each treatment (week 0 to week 3 of each treatment))
- Plasma antioxidant capacity (ORAC, FRAP)(baseline to end of each treatment (week 0 to week 3 of each treatment))
- serum amyloid A(baseline to end of each treatment (week 0 to week 3 of each treatment))
- hs-CRP(baseline to end of each treatment (week 0 to week 3 of each treatment))
- IL-6(baseline to end of each treatment (week 0 to week 3 of each treatment))
- TNF-alpha(baseline to end of each treatment (week 0 to week 3 of each treatment))
- gastrointestinal symptom survey(baseline to end of each treatment (week 0 to week 3 of each treatment))
- stool consistency (Bristol stool scale)(baseline to end of each treatment (week 0 to week 3 of each treatment))
- Quality of Life questionaire (Quality Metrics SF-36)(baseline to end of each treatment (week 0 to week 3 of each treatment))
研究者
研究点 (2)
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