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临床试验/JPRN-jRCT1090220274
JPRN-jRCT1090220274已完成Unknown

Effect on the long-term administration of functional carbohydrate on various biomarkers - Allu trail to lipid

Matsutani Chemical Industry Co., Ltd.0 个研究点目标入组 90 人开始时间: 2017年1月16日最近更新:
适应症

试验速览

阶段
Unknown
状态
已完成
入组人数
90

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 with high normal blood glucose ~ borderline diabetic and high LDL-C
  • (3)Subjects with insulin resistance calculator(HOMA-IR) and over 2.5, and high LDL-C
  • (4)Subjects with high LDL-C
  • (5)Subjects who can come to designated institution on scheduled date of test
  • (6)Subjects who can make self-judgment and are voluntarily giving written informed consent.
  • -High normal blood glucose ~ borderline diabetic: fasting blood glucose levels from 100mg/dl and below 126mg/dl, or HbA1c(NGSP) levels from 6.0% and below 6.5%.
  • -High LDL-C: LDL-C levels from 120mg/dl and below 160mg/dl.
  • -Number of subjects: as a rule, (2)+(3)=45, (4)=45.

排除标准

  • (1) These prescreened medicine.
  • (2) Subjects who constantly take oral medicines, functional foods and/or supplements that have a possibility to affect blood glucose levels and lipid.
  • (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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