Safety verification test of long-term ingested functional carbohydrate for diabetic patients
- Conditions
- diabetes
- Registration Number
- JPRN-jRCT1090220287
- Lead Sponsor
- Matsutani Chemical Industry Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
(1)Males and females aged 20 to 64 years old
(2) Subjects who are diagnosed with diabetes and treated with diabetic medicine or insulin
(3) Subjects with LDL-C levels from 120mg/dL to below 160mg/dL
(4)Subjects who can come to designated institution on scheduled date of test
(5)Subjects who can make self-judgment and are voluntarily giving written informed consent
(1) Subjects who take antihyperlipidemic drug except statin
(2) Females who are pregnant or lactating, and females who have possibility of pregnancy
(3) Subjects who donated blood and/or blood components more than 200 mL within 4 weeks prior to the test
(4) Males who donated blood and/or blood components more than 400 ml within 12 weeks prior to the test
(5) Females who donated blood and/or blood components more than 400 ml within 16 weeks prior to the test
(6) 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
(7) 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
(8) Subjects who are participating in other clinical tests, and/or subjects who participated in other clinical tests within 4 weeks prior to the test
(9) Subjects who consume excessive amount of alcohol or smoke heavily (more than 21 cigarettes a day)
(10) Subjects who have extremely irregular dining habits, and/or subjects who work midnight or irregular shifts
(11) 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 are allergic to the test foods
(12) Subjects who are judged as unsuitable for this study by principal investigator or sub-investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method DL-C, HDL-C
- Secondary Outcome Measures
Name Time Method lipoprotein fractions, carotid artery