UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011446 |
|---|---|
| Receipt number | R000013387 |
| Scientific Title | Chlorella ingestion in borderline diabetics: a double blind, placebo-controlled study and open study |
| Date of disclosure of the study information | 2013/08/15 |
| Last modified on | 2023/02/16 16:47:07 |
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Basic information
Public title
Chlorella ingestion in borderline diabetics:
a double blind, placebo-controlled study and open study
Acronym
Chlorella ingestion in borderline diabetics
Scientific Title
Chlorella ingestion in borderline diabetics:
a double blind, placebo-controlled study and open study
Scientific Title:Acronym
Chlorella ingestion in borderline diabetics
Region
| Japan |
Condition
Condition
borderline diabetics
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
We will conduct study with patient who are borderline diabetes, and look at the effect of 1 year intake of Sun chlorella tablets on blood glucose-related clinical test result (HbA1c, etc), expression of adipo-cytokine such as resistin, and gene expression profile using DNA microarray, and validate its superiority to placebo.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c,FFA, resistin gene expression and adipocytokine
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
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 months.
Interventions/Control_2
Receive 8 g / day of Placebo (lactose) for 6 months. After 6 months, Receive 8g / day of Chlorella for 6 months.
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
| 64 | years-old | >= |
Gender
Male
Key inclusion criteria
1. 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)BMI>30
2)Patient of the Diabetes or hypertension or hyperlipidemia.
systolic blood pressure > 160 mmHg
diastolic blood > 100 mmHg
HbA1c > 7.4%
LDL-Cholesterol > 190 mg/dL
3)These prescreened medicine.
4)These having Food for Specified Health Uses (FOSHU) and/or health food.
5)These having a history of serious diseases in metabolic and/or endocrine system.
6)Those that have extremely disheveled lifestyle and/or dietary habits.
7)Heavy alcohol drinker.
8)Those that are considered to be ineligible to participate to this test due to their abnormality at the screening test.
9)Diabetes or hypertension or hyperlipidemia patient who is NOT accompanied by obesity, but whose disease is attributed etiologically to hereditary factor or other non-obesity factors.
10)Those that are judged not applicable to this study by physicians.
11)The subject who takes warfarin.
12)Those participating in another trial or other investigational.
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
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
DNA Chip Research Inc.
Division name
Research & Development Dept.
Zip code
Address
1-1-43, Suehiro-cho, Tsurumi-ku, Yokohama
TEL
Homepage URL
Sponsor or person
Institute
Sun Chlorella Corp.
Institute
Department
Personal name
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
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
公益財団法人ライフ・エクステンション研究所付属柳橋病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 08 | Month | 15 | 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
| 2012 | Year | 08 | Month | 29 | Day |
Date of IRB
| 2012 | Year | 11 | Month | 22 | Day |
Anticipated trial start date
| 2013 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 01 | Month | 30 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 30 | Day |
Date trial data considered complete
| 2014 | Year | 03 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 07 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 10 | Day |
Last modified on
| 2023 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013387
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