UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Verifying the control effects of glucose absorption through the comparison of SekirenB2 with a placebo in double blind cross over comparative study.
Title of the study (Brief title)	PRT-AD-MF-OGTT-SEKIREN-01-01
Region	Japan

Condition
Condition	Healthy individual
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	SekirenB2(Adaptgen Pharmaceutial Co. Ltd.,) is test food of this clinical trial. When we used test food that was made from SekirenB2 and LB-Scr(Laboag Co. Ltd.,) for diabetic in other clinical trial, we could confirm validity of the test food clearly. And Echevaria grauca is raw material of SekirenB2 and functional foods material, which we can expect to control absorption of glucose in a small intestine and rising of blood glucose level. That's why we use SekirenB2 and do carbohydrate tolerance test in this clinical trial. We check rise inhibiting effect of glucose level by SekirenB2 of functional-foods that has safety and hasn't side effect.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	We decide the value in front of test food ingestion start is standard and it is 0 hour. We check the amount of change of the blood glucose level after ingesting test food and measure the level in 0.5, 1, 1.5, 2, 2.5, 3, 4 hours later.
Key secondary outcomes	We decide the value in front of test food ingestion start is standard and it is 0 hour. We check the amount of change of theblood test item and the urinalysis item 4 hours later.

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Cluster
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	Medicine Behavior,custom
Interventions/Control_1	SekirenB2
Interventions/Control_2	Placebo
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	1)A person who is Japanese and between 20 and 65 years old at the time of informed consent.(Sex is not asked) 2)A person who has blood pressure and body temperature of the following value at this clinical trial and the screening. Blood pressure: Systolic Less than 140mmHg Diastolic Less than 90mmHg Body temperature: 35.5-37.0 degrees 3)A person whose HbA1c is applied to following either value. a)HbA1c:6.4% or less b)HbA1c:6.5% or more and less than 7.0% 4)A person must be received to explanation about the test food,objective of clinical test and side effects by clinical research investigator or sub investigator. And the person who understood explanation well,agreed with written informed consent and desired participation in the clinical trial. 5)A person who can quit smoking on the day of clinical trial. 6)A person who can obey management manner in implementation medical institutions. 7)A person who can do screening test within 60 days of this clinical trials implementation and was qualified by clinical research investigator or sub clinical research investigator. Exclusion criteria.
Key exclusion criteria	1)A person who is suspected to have an impaired liver function on result of clinical laboratory test at the screening. a) T-Bil 3.0 or more b) GOT,GPT More than normalcy upper limit multiply 2.5(100 or more) c) A1-P More than normalcy upper limit multiply 2.5 d) gamma-GTP More than normalcy upper limit multiply 1.5 e) LDH More than normalcy upper limit multiply 1.5 2)A person who has disease of gastrointestinal tract, kidney and the heart which have an influence on absorption, distribution, metabolism and the excretion. 3)A person who has surgical history of gastrointestinal tract site. For example gastrectomy, stomach and intestines suture, intestinal tract resection and so on. 4)A person who has food allergy. 5)A person who has alcohol or drug dependence. 6)A person who treated diabetes within 3 months at the time of obtaining informed consent. 7)A person who participated in other clinical study of new drug or received medical treatment within 3 months at the time of obtaining informed consent. 8)A person who take other medicine from less than one week to start this clinical trial. 9)A person who has taken the whole blood bleeds or ingredient blood collecting (plasma or plaque component blood collecting) more than 200ml within 3 months at the time of obtaining informed consent or during the period between the time of obtaining informed consent and this clinical trial implementation. 10)A person who can't obey management manner or can't report about subjective symptoms during participation in clinical trials. 11)In addition a person who is identified as improper by the responsibility researcher or subresponsibility researcher. 12)A woman who is pregnant or breastfeeding.
Target sample size	20

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
Email	info@m-fusion.co.jp

Sponsor
Institute	ADAPTGEN PHARMACEUTICAL CO.,LTD.
Institute
Department

Funding Source
Organization	ADAPTGEN PHARMACEUTICAL 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.
Name of secondary funｄer(s)

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	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	2014 Year 05 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 01 Month 28 Day
Anticipated trial start date	2014 Year 05 Month 26 Day
Last follow-up date	2015 Year 03 Month 31 Day
Date of closure to data entry	2015 Year 04 Month 20 Day
Date trial data considered complete	2015 Year 04 Month 30 Day
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 05 Month 19 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=R000016307