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

Not Applicable

• Conditions: Type 2 Diabetes Mellitus

• Registration Number: JPRN-UMIN000009542
• Lead Sponsor: ABOAG Co.,Ltd. (Charge of clinical research) (Clinical research personnel) Masahiro Tanaka, Kazuya Nishimoto, Daisuke Hakkaku, Motoyuki Akita

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-12-14
• Study Completion: 2013-09-19
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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.