UMIN-CTR Clinical Trial

Basic information
Public title	Effect of the test food containing plant extract on blood glucose -A randomized, double-blind, placebo-controlled, parallel-group study-
Acronym	Effect of the test food containing plant extract on blood glucose
Scientific Title	Effect of the test food containing plant extract on blood glucose -A randomized, double-blind, placebo-controlled, parallel-group study-
Scientific Title:Acronym	Effect of the test food containing plant extract on blood glucose
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the effect of the test food on blood glucose
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	HbA1c
Key secondary outcomes	Fasting blood glucose level, Blood insulin level, HOMA-IR, 1,5-AG, Body weight, BMI, Triglycerides

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake of the test food for 12 weeks (6 tablets/day)
Interventions/Control_2	Intake of the placebo food for 12 weeks (6 tablets/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	1)Healthy males and females aged 20 to 64 years 2)Subjects whose fasting blood glucose levels are less than 125 mg/dL and HbA1c are 5.6% to 6.4% 3)Subjects who take 3 meals a day 4)Subjects who don't habitually take much alcohol 5)Subjects who have understood the purpose and contents of the study and agree to participate by signing the written informed consent 6)Subjects who are not diagnosed disease by the doctor in charge
Key exclusion criteria	1)Subjects who are or have a history of diabetes 2)Subjects who habitually take medecine which may affect blood glucose level 3)Subjects who can't stop taking supplements which may affect blood glucose level 4)Subjects who have allergy to the test food 5)Subjects who have kidney disease, liver disease, heart disease, respiratory disease, endocrine disease, or other metabolic disease 6)Subjects who have chronic disease and habitually take medecine 7)Subjects who have digestive disease or a history of digestive surgery 8)Subjects who have severe diarrehea 7 days before the screening tests 9)Subjects who are considered as an inappropriate candidate based on the screening tests by the doctor in charge 10)Subjects who are diagnosed anemia 11)Subjects who donated blood of over 200 mL in the past 1 month or over 400 mL in the past 3 months 12)Subjects who are or have a history of alcoholism or drug addict 13)Shift worker or midnight shift worker 14)Subjects who are planning to participate in other clinical study during the study period or have participated in the past 1 month 15)Subjects who are pregnant, lactating, or planning to get pregnant 16)Subjects who are considered as an inappropriate candidate for other reasons by the doctor in charge
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Yoshitaka Middle name Last name Iwama
Organization	Nihonbashi Cardiology Clinic
Division name	Director
Zip code	103-0001
Address	Kyodo Bldg. #201, 13-4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
TEL	03-5641-4133
Email	yiwama@well-sleep.jp

Public contact
Name of contact person	1st name Yoshika Middle name Last name Komori
Organization	KSO Corporation
Division name	Sales department
Zip code	105-0023
Address	1-9-7 Shibaura, Minato-ku, Tokyo
TEL	03-3452-7733
Homepage URL
Email	eigyou27@kso.co.jp

Sponsor
Institute	KSO Corporation
Institute
Department

Funding Source
Organization	KOBAYASHI Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethical Committee of Nihonbashi Cardiology Clinic
Address	Kyodo Bldg. #201, 13-4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
Tel	03-5641-4133
Email	niho-jimucho@well-sleep.jp

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	日本橋循環器科クリニック

Other administrative information
Date of disclosure of the study information	2021 Year 06 Month 18 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	2021 Year 05 Month 14 Day
Date of IRB	2021 Year 05 Month 26 Day
Anticipated trial start date	2021 Year 06 Month 19 Day
Last follow-up date	2021 Year 11 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 06 Month 04 Day
Last modified on	2021 Year 12 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050396