NCT02702934已完成不适用
Metabolic Effects of High-amylose Wheat-based Rusks in Healthy Subjects. A Pilot Study.
Federico II University2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2015年5月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Blood glucose
研究概览
简要总结
Amylose-amylopectin ratio may influence the rate of starch digestion. This randomized controlled study evaluated the postprandial metabolic effects of amylose-rich- wheat- based rusks in overweight subjects.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Overweight/obese;
- •30-60 years.
排除标准
- •age <30 and >60 years;
- •fasting triglycerides ≥400 mg/dl;
- •fasting cholesterol >270 mg/dl;
- •cardiovascular events (myocardial infarction or stroke) during the 6 months prior to the study;
- •established diabetes mellitus or any chronic disease;
- •renal and liver failure (creatinine >1.7 mg/dl and transaminases >2 times than normal values, respectively);
- •anaemia (Hb <12 g /dl);
- •any chronic disease.
研究组 & 干预措施
High-amylose rusks
Experimental
Test meal with 100g of carbohydrates coming from high-amylose rusks
干预措施: Test meal (Other)
Control rusks
Active Comparator
Test meal with 100g of carbohydrates coming from regular rusks used as control
干预措施: Test meal (Other)
结局指标
主要结局
Blood glucose
时间窗: 4 hours
Incremental area under the curve
次要结局
- Intestinal fermentation(4 hours)
- Blood insulin(4 hours)
- Blood triglycerides(4 hours)
研究者
rivellese angela
Professor
Federico II University
研究点 (2)
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