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

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000009542
• Date of registration: 14/12/2012
• Prospective Registration: Yes
• Primary sponsor: LABOAG Co.,Ltd. (Charge of clinical research) (Clinical research personnel) Masahiro Tanaka, Kazuya Nishimoto, Daisuke Hakkaku, Motoyuki Akita
• 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
• 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 - PRT-LB-MF-DM-LBSCR-01-01
• Date of first enrolment: 2013/01/15
• Target sample size: 34
• Recruitment status: Complete: follow-up complete
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010794
• Study type: Interventional
• Study design: Parallel Randomized
• Phase: Not applicable

Countries of recruitment

Japan

Contacts

• Name: Shigehiro Kure
• Affiliation: Sanbongi Clinic Clinic Director

• Name: Hiromichi Hayashi
• Affiliation: Medical Fusion Co.,Ltd. Clinical Development Division

Key inclusion & exclusion criteria

Inclusion criteria:
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.

Age minimum: 20years-old
Age maximum: 65years-old
Gender: Male and Female

Health Condition(s) or Problem(s) studied

Type 2 Diabetes Mellitus

Intervention(s)

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
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

Primary Outcome(s)

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.

Secondary Outcome(s)

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.

Secondary ID(s)

JMA-IIA00106

Source(s) of Monetary Support

Shachihata Inc,. Provision of "PC approval"management software and electronic seal

LABOAG Co.,Ltd.

Secondary Sponsor(s)

1,Medical institutions conduct clinical research MEDOC Medical Dock&Clinic 2,CRO Medical Fusion Co.,Ltd. 3,OEM ADAPTGEN PHARMACEUTICAL CO.,LTD.

Ethics review

Status: YES
Approval date:
Contact:

Results

• Date Completed: 19/09/2013