JPRN-jRCT1090220275已完成Unknown
Safety verification test of long-term ingested functional carbohydrate for hyperlipidemic persons - Allu trail to lipid and glucose metabolism
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 20
研究概览
简要总结
暂无简介。
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
- •(1)Males and females aged 20 to 64 years old
- •(2)Subjects who are diagnosed with hyperlipidemia and take statin
- •(3)Subjects who can come to designated institution on scheduled date of test
- •(4)Subjects who can make self-judgment and are voluntarily giving written informed consent
排除标准
- •(1) Subjects with LDL-C levels over 160mg/dL
- •(2) Subjects who take antihyperlipidemic drug except statin
- •(3) Females who are pregnant or lactating, and females who have possibility of pregnancy
- •(4) Subjects who donated blood and/or blood components more than 200 mL within 4 weeks prior to the test
- •(5) Males who donated blood and/or blood components more than 400 ml within 12 weeks prior to the test
- •(6) Females who donated blood and/or blood components more than 400 ml within 16 weeks prior to the test
- •(7) Males who were collected blood and blood components more than 1200 ml within 12 months prior to the test when planned blood sampling amount of this test is added
- •(8) Females who were collected blood and blood components more than 800 ml within 12 months prior to the test when planned blood sampling amount of this test is added
- •(9) Subjects who are participating in other clinical tests, and/or subjects who participated in other clinical tests within 4 weeks prior to the test
- •(10) Subjects who consume excessive amount of alcohol or smoke heavily (more than 21 cigarettes a day)
- •(11) Subjects who have extremely irregular dining habits, and/or subjects who work midnight or irregular shifts
- •(12) Subjects who falls under any of the following criteria
- •(a) Subjects who have heart disease, liver disease, or kidney disease (including the complication of other diseases)
- •(b) Subjects who have medical history of cardiovascular diseases
- •(c) Subjects who have diabetes
- •(d) Subjects who are allergic to the test foods
- •(13) Subjects who are judged as unsuitable for this study by principal investigator or sub-investigator
研究者
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