UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009130
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Chlorella ingestion and suppression of resistin gene expression in borderline diabetics:
a randomized, placebo-controlled study
Acronym Chlorella ingestion and suppression of resistin gene expression in borderline diabetics
Scientific Title Chlorella ingestion and suppression of resistin gene expression in borderline diabetics:
a randomized, placebo-controlled study
Scientific Title:Acronym Chlorella ingestion and suppression of resistin gene expression in borderline diabetics
Region
Japan

Condition
Condition borderline diabetics
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes HbA1c,HDL-C,LDL-C,TCHL,IL-6
Key secondary outcomes Gene expression( microarray and qRT-PCR )

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Receive 8 g / day of Chlorella for 12 weeks.
Interventions/Control_2 Receive 8 g / day of Placebo(lactose) for 12 weeks.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
40 years-old <=
Age-upper limit
55 years-old >
Gender Male
Key inclusion criteria 1. Healthy adult Japanese males.
2. HbA1c (NGSP values) concentration; between 6.0% and 6.5% at the screening.
3. Written informed is required.
Key exclusion criteria 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.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Michie Kobayashi
Organization DNA Chip Research Inc.
Division name Research & Development Dept.
Zip code
Address 1-1-43, Suehiro-cho, Tsurumi-ku, Yokohama
TEL 045-500-5211
Email dnachip-support@dna-chip.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Michie Kobayashi
Organization DNA Chip Research Inc.
Division name Research & Development Dept.
Zip code
Address 1-1-43, Suehiro-cho, Tsurumi-ku, Yokohama
TEL 045-500-5211
Homepage URL
Email dnachip-support@dna-chip.co.jp

Sponsor
Institute CPCC Inc.
Institute
Department

Funding Source
Organization Sun Chlorella Corp.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions チヨダパラメディカルケアクリニック

Other administrative information
Date of disclosure of the study information
2012 Year 10 Month 25 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2010 Year 06 Month 04 Day
Date of IRB
Anticipated trial start date
2010 Year 06 Month 18 Day
Last follow-up date
2010 Year 12 Month 18 Day
Date of closure to data entry
2010 Year 12 Month 27 Day
Date trial data considered complete
2011 Year 01 Month 20 Day
Date analysis concluded
2011 Year 11 Month 15 Day

Other
Other related information

Management information
Registered date
2012 Year 10 Month 17 Day
Last modified on
2014 Year 04 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010703

Research Plan
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
Registered date File name
2014/04/24 SC210C01症例報告書_仕様書.xls

Research case data
Registered date File name
2014/04/24 SC210C01症例報告書.xls


Contact us.