UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Shigehiro Kure
Organization	Sanbongi Clinic
Division name	Clinic Director
Address	2-1, Hosohazama, Sambongi-cho, Nisshin-shi, Aichi, 470-0101, Japan
TEL	0561-56-4532
Email	shigehiro_kure@yahoo.co.jp

Public contact
Name of contact person	Hiromichi Hayashi
Organization	Medical Fusion Co.,Ltd.
Division name	Clinical Development Division
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
Email	info@m-fusion.co.jp

Sponsor
Institute	LABOAG Co.,Ltd. (Charge of clinical research) (Clinical research personnel) Masahiro Tanaka, Kazuya Nishimoto, Daisuke Hakkaku, Motoyuki Akita
Institute
Department

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

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 10 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010794