UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009542 |
|---|---|
| Receipt number | R000010794 |
| Scientific Title | Explorative trial of efficacy of the food which contains LB-Scr as the main ingredients for type 2 diabetic a randomized, placebo controlled, parallel-group trial |
| Date of disclosure of the study information | 2012/12/14 |
| Last modified on | 2017/09/08 16:07:20 |
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Basic information
Public title
Explorative trial of efficacy of the food which contains LB-Scr as the main ingredients for type 2 diabetic a randomized, placebo controlled, parallel-group trial
Acronym
PRT-LB-MF-DM-LBSCR-01-01
Scientific Title
Explorative trial of efficacy of the food which contains LB-Scr as the main ingredients for type 2 diabetic a randomized, placebo controlled, parallel-group trial
Scientific Title:Acronym
PRT-LB-MF-DM-LBSCR-01-01
Region
| Japan |
Condition
Condition
Type 2 Diabetes Mellitus
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Endocrinology and Metabolism | Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The suppression or normalization effect of the food consisting of LB-Scr and Sekiren B2 for the blood glucose level, and relaxation effect against diabetes mellitus are verified. These are evaluated for a placebo.
The value of HbA1c is investigated as items of examination.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The suppression or normalization effect of the food consisting of LB-Scr and Sekiren B2 for the blood glucose level, and relaxation effect against diabetes mellitus are verified. These are evaluated for a placebo.
The value of HbA1c is investigated as items of examination. The HbA1c value is measured 0 day, 28 days, 56 days, 84 days, 112 days, 140 days, and 168 days after the food intake start.
Key secondary outcomes
A general blood test, biochemical examination, urinalysis, IRI, an IRI antibody, GLU (glucose) , HOMA-B (insulin secretory capacity); changes of skin condition with Robo Skin Analyzer RSA 50 (Inforward,inc ); other usefulness and safeties such as side effects are verified.
(A general blood test, a biochemical examination, urinalysis, and skin condition)
0 day, 28 days, 56 days, 84 days, 112 days, 140 days, and 168 days after the food intake start..
(IRI, an IRI antibody, GLU, and HOMA-B)
0 day, 56 days, 112 days, and 168 days after the food intake start.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
LB-Scr and Sekiren B2
Ingestion period:168 plus or minus
7day
Intake:1800mg/time-Time before a meal 3 times
The number of times of a visit to the hospital: First day,28th day, 56th day, 84th days 112th day and 168th day
Interventions/Control_2
Placebo
Ingestion period:168 plus or minus 7day
Intake:1800mg/time-Time before a meal 3times
The number of times of a visit to the hospital: First day, 28th day, 56th day, 84th days 112th day and 168th day
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The subjects for the experiment must be apatient who meets all the following standards.
1)The patient who is Japanese and is between 20 and 45 years old at the time of Informed Consent (Sex is not asked).
2)The patient who is taking medical treatment as a visitor or wishes to take medical treatment as a visitor (Only visitors).
3)The patient who has been diagnosed with diabetes type II based on the guidelines for diabetes in 2012 of the Japan Diabetes Society and whose HbA1c is between 6.5% and 9.5%.
4)The patient who is taking medicine for diabetes or who is not taking medicine for diabetes but can control.
5) Patients who can get written informed consent before enrolling the study.
Key exclusion criteria
The patient who corresponds to either of the followings can't participate in this clinical study.
1)The patient who changed diabetic medicine in the observation term till the first day of ingestion
2)The patient who is in doubt of type 1 diabetes or the patient who is diagnosed with type 1 diabetes.
3)The patient who is receiving medication of the insulin
4)The patient who has a food allergy of mushrooms (fungi) and the patient who has a chronic food allergy
5)The patient who has the past of myocardial infarction
6)The patient who has the past of a coronary-arterial-blood line reconstruction way (PCI or CABG)
7)The patient who merges unstable angina pectoris
8)The patient who has the past of cerebrovascular disorder (except for asymptomatic lacunar infarction)
9)The patient who has the past of heart failure
10)The patient who has critical liver disease
11)The patient who has critical renal disease
12)The woman who is pregnant or the woman who wishes to become pregnant during exam time.
13)The woman who is under breast-feeding
14)The patient who has participated in other clinical study or received medical treatment of new drug within 12 weeks before the ingestion start of test meal.
15)The patient who is taking medical treatment of psychiatric disorder or the patient who is judged by a doctor to need medical treatment of psychiatric disorder.
16)In addition, the person who identified as improper by the investigator or subinvestigators.
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigehiro Kure |
Organization
Sanbongi Clinic
Division name
Clinic Director
Zip code
Address
2-1, Hosohazama, Sambongi-cho, Nisshin-shi, Aichi, 470-0101, Japan
TEL
0561-56-4532
shigehiro_kure@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromichi Hayashi |
Organization
Medical Fusion Co.,Ltd.
Division name
Clinical Development Division
Zip code
Address
Nagoya Life Science Incubator,2-22-8,Chikusa,Chikusa-ku,Nagoya,Aichi,464-0858,Japan
TEL
052-745-3300
Homepage URL
http://m-fusion.co.jp
info@m-fusion.co.jp
Sponsor or person
Institute
LABOAG Co.,Ltd.
(Charge of clinical research)
(Clinical research personnel)
Masahiro Tanaka, Kazuya Nishimoto, Daisuke Hakkaku, Motoyuki Akita
Institute
Department
Personal name
Funding Source
Organization
LABOAG Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
1,Medical institutions conduct clinical research
MEDOC Medical Dock&Clinic
2,CRO
Medical Fusion Co.,Ltd.
3,OEM
ADAPTGEN PHARMACEUTICAL CO.,LTD.
Name of secondary funder(s)
Shachihata Inc,.
Provision of "PC approval"management software and electronic seal
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
JMA-IIA00106
Org. issuing International ID_1
JMACCT CTR
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
医療法人メドック健康クリニック（愛知県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 14 | 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 | 10 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2013 | Year | 09 | Month | 19 | Day |
Date of closure to data entry
| 2013 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2013 | Year | 12 | Month | 09 | Day |
Date analysis concluded
| 2013 | Year | 12 | Month | 30 | Day |
Other
Other related information
Chiyo foods Co.,Ltd.
Chiyo Nakata
URL:http://www.khaos.co.jp/
(Audit the implementation date)
IRB CRO:Medical institution
July 30 2013
CRO:IRB
July 31 2013
Management information
Registered date
| 2012 | Year | 12 | Month | 13 | Day |
Last modified on
| 2017 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010794
