Unique ID issued by UMIN | UMIN000009130 |
---|---|
Receipt number | R000010703 |
Scientific Title | Chlorella ingestion and suppression of resistin gene expression in borderline diabetics: a randomized, placebo-controlled study |
Date of disclosure of the study information | 2012/10/25 |
Last modified on | 2014/04/28 17:35:50 |
Chlorella ingestion and suppression of resistin gene expression in borderline diabetics:
a randomized, placebo-controlled study
Chlorella ingestion and suppression of resistin gene expression in borderline diabetics
Chlorella ingestion and suppression of resistin gene expression in borderline diabetics:
a randomized, placebo-controlled study
Chlorella ingestion and suppression of resistin gene expression in borderline diabetics
Japan |
borderline diabetics
Not applicable |
Others
NO
Chlorella ingestion improves blood glucose and cholesterol concentrations in mice and humans, although no reports have evaluated Chlorella effects in borderline diabetics. Therefore, we conducted a randomized, placebo-controlled trial for borderline diabetics using laboratory results and comprehensive gene analysis as outcomes.
Efficacy
Exploratory
Pragmatic
Not applicable
HbA1c,HDL-C,LDL-C,TCHL,IL-6
Gene expression( microarray and qRT-PCR )
Interventional
Parallel
Randomized
Double blind -all involved are blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
No need to know
2
Prevention
Food |
Receive 8 g / day of Chlorella for 12 weeks.
Receive 8 g / day of Placebo(lactose) for 12 weeks.
40 | years-old | <= |
55 | years-old | > |
Male
1. Healthy adult Japanese males.
2. HbA1c (NGSP values) concentration; between 6.0% and 6.5% at the screening.
3. Written informed is required.
1. These having Food for Specified Health Uses (FOSHU) and/or health food.
2. These prescreened medicine.
3. These having a history of serious diseases in metabolic and/or endocrine system
4. Those that have extremely disheveled lifestyle and/or dietary habits.
5. Heavy alcohol drinker.
6. Those that are considered to be ineligible to participate to this test due to their abnormality at the screening test.
7. Those having an allergy to food and/or drug
8. Those participating in another trial or other investigational.
9. Those that are judged not applicable to this study by physicians.
60
1st name | |
Middle name | |
Last name | Michie Kobayashi |
DNA Chip Research Inc.
Research & Development Dept.
1-1-43, Suehiro-cho, Tsurumi-ku, Yokohama
045-500-5211
dnachip-support@dna-chip.co.jp
1st name | |
Middle name | |
Last name | Michie Kobayashi |
DNA Chip Research Inc.
Research & Development Dept.
1-1-43, Suehiro-cho, Tsurumi-ku, Yokohama
045-500-5211
dnachip-support@dna-chip.co.jp
CPCC Inc.
Sun Chlorella Corp.
Profit organization
Japan
NO
チヨダパラメディカルケアクリニック
2012 | Year | 10 | Month | 25 | Day |
Unpublished
Completed
2010 | Year | 06 | Month | 04 | Day |
2010 | Year | 06 | Month | 18 | Day |
2010 | Year | 12 | Month | 18 | Day |
2010 | Year | 12 | Month | 27 | Day |
2011 | Year | 01 | Month | 20 | Day |
2011 | Year | 11 | Month | 15 | Day |
2012 | Year | 10 | Month | 17 | Day |
2014 | Year | 04 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010703
Research Plan | |
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Registered date | File name |
2014/04/17 | 10.06.04 糖尿病予備軍プロトコル.PDF |
Research case data specifications | |
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Registered date | File name |
2014/04/24 | SC210C01症例報告書_仕様書.xls |
Research case data | |
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Registered date | File name |
2014/04/24 | SC210C01症例報告書.xls |