JPRN-jRCTs031190088已完成未知
Effects of Leucosaccharide on glucose regulation and gut environment in healthy volunteers; randomized, placebo-controlled, double blinded trial
Irie Junichiro0 个研究点目标入组 40 人开始时间: 2019年9月2日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
The effect of supression of plasma glucose by administration of leucosaccharide was not demonstrated in this study. - Since this study suggested that GIP may increase by leucosaccharide administration, it was expected that leucosaccharide administration to the subjects whose glucose metabolism function was lowered improve the glycemic control. - This study confirmed the safety of single administration of leucosaccharide to healthy subject.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 65age old（—）
- 性别
- All
入选标准
- •Healthy volunteers without any clinically diagnosed diseases, who meet all of the following criteria, are included in the study.
- •1) male and female aged 20 years or older and 65 years or younger
- •2) subjects who provide their written consent form to participate in the study after full explanation and enough understanding of the study
- •3) subjects who had a medical examination within 1 year, and who were not diagnosed with apparent glucose metabolism disorder (fasting plasma glucose of 126 mg/dl or higher, or casual plasma glucose of 200 mg/dl or higher) at that time
排除标准
- •Subjects who meet any of the following criteria are excluded from the study.
- •1) subjects who are treated for clinically diagnosed diseases
- •2) subjects with malignant neoplasm
- •3) subjects with severe infection
- •4) subjects with uncontrolled psychiatric disorder
- •5) subjects with history of uncontrolled allergy to foods or drugs
- •6) subjects who are pregnant, possibly pregnant, within 90 days after delivery, or during breastfeeding
- •7) subjects who cannot provide written consent form, or who cannot understand the summary and the purpose of the study
- •8) subjects who are considered to be unsuitable for participation in the study by the responsible investigator or investigators due to the safety
研究者
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