NCT01528631已完成不适用
Randomized Controlled Double-blind Nutritional Intervention Trial to Evaluate the Effects of D-fagomine on Glycaemic Response to Sucrose in Men
Bioglane2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2012年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Glycaemic response to sucrose
研究概览
简要总结
The aim of this study is to evaluate the effect of D-fagomine on glycaemic response to sucrose in men.
详细描述
To determine and compare glycaemic response to sucrose of D-Fagomine and control in the timeframe of 180 minutes.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Males between the ages of 20 and 70 willing and able to provide written informed consent.
排除标准
- •LDL cholesterol levels higher than 189 mg/dl
- •Triglycerides higher than 350 mg/dl (the threshold level to determine c-LDL using the Friedewald formula)
- •Physical examinations and routine biochemical analysis shall be conducted to rule out pathologies.
- •Consumption of supplements or acetylsalicylic acid
- •Chronic alcoholism
- •Body mass index (BMI) greater than 30 kg/m2
- •Previous antihypertensive treatment at the start of the trial that has not finished at least 2 months before beginning the study
- •Diabetes mellitus (if the fasting blood glucose is higher than 126 mg/dl, the test should be repeated and confirmed)
- •Kidney disease (serum creatine levels above 1,4 mg/dl for women and above 1,5 mg/dl for men)
- •Acute infectious diseases, malignant tumors, severe liver failure, respiratory failure associated with chronic or endocrine diseases
- •Other conditions such as special dietary needs
- •To be participating or having participated in a clinical trial within the last 3 months
- •Inability to continue the study
- •History of gastrointestinal disease which may alter the absorption of nutrients
- •Depressive disorder or thoughts of self-injury
结局指标
主要结局
Glycaemic response to sucrose
时间窗: 0-180 minutes
次要结局
- Insulin in venous plasma(0-180 minutes)
研究者
研究点 (2)
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