UMIN-CTR Clinical Trial

Basic information
Public title	Study for effect on blood glucose level change by ingestion of red clover extract
Acronym	Study for effect by ingestion of red clover extract
Scientific Title	Study for effect on blood glucose level change by ingestion of red clover extract
Scientific Title:Acronym	Study for effect by ingestion of red clover extract
Region	Japan

Condition
Condition	Healthy Adults
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify inhibition effect on postprandial blood glucose level rise by a single ingesting of red clover extract and effect on fasting blood glucose level change after 8 weeks of continuous intake.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	HbA1c 8 weeks after continuous intake Time course of blood glucose concentration changes before and after a single ingesting(C,Cmax,Tmax,delta AUC) *Measure at before ingestion and 30, 60, 90, and 120 minutes after ingestion.
Key secondary outcomes	Time course of blood insulin concentration changes before and after a single ingesting(C,Cmax,Tmax,delta AUC) *Measure at just before ingestion and 30, 60, 90, and 120 minutes after ingestion. fasting blood glucose level 8 weeks after continuous intake fasting blood insulin level 8 weeks after continuous intake Physical examination (body height, weight, BMI)

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	Sugar load*1 at the time of screening and Sugar load after taking red clover extract 1.91g on the test day before intake. In addition, take red clover extract 1.91g every day for 8 weeks, once a day at dinner, immediately before meals or with meals. *1: Sugar loading is performed by ingesting 200 mL of water in which 50 g of maltose is dissolved for 5 to 10 minutes.
Interventions/Control_2	Sugar load*2 at the time of screening and Sugar load after taking dextrin 1.91g on the test day before intake. In addition, take dextrin 1.91g every day for 8 weeks, once a day at dinner, immediately before meals or with meals. *2: Sugar loading is performed by ingesting 200 mL of water in which 50 g of maltose is dissolved for 5 to 10 minutes.
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.Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document 2.Healthy Japanese over 20 years old and under 65 at the time of consent acquisition 3.Those whose BMI less than 25 at the time of screening 4.Those whose blood glucose concentration is less than 126 mg per dL at the time of screening 5.Those with occasional blood glucose levels of less than 200 mg per dL at screening 6.Those whose blood HbA1c is less than 6.5% at the time of screening 7.Those who apply to 6 and are top 40 of numerical value of HbA1c.
Key exclusion criteria	1.Those who have a chronic disease and are undergoing medication, those with a serious disease history 2.Those who are allergic to the test food 3.Those who regularly use medicines, specific insurance foods, health foods, etc. that may affect blood glucose levels 4.Those who have participated in other tests within the first month before the start of the exam, or who are planning to participate in other exams after this exam consent 5.Those who are judged ineligible at the discretion of the examining supervisor and research leader 6.Those who are breast-feeding, pregnant, and are planning or hoping pregnancy during the exam
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Takamasa Middle name Last name Masuda
Organization	Healthcare Systems Co., Ltd.
Division name	Research and Development Department
Zip code	105-0004
Address	Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL	03-6809-2722
Email	masudat@hc-sys.jp

Public contact
Name of contact person	1st name Takamasa Middle name Last name Masuda
Organization	Healthcare Systems Co., Ltd.
Division name	Research and Development Department
Zip code	105-0004
Address	Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL	03-6809-2722
Homepage URL
Email	masudat@hc-sys.jp

Sponsor
Institute	Healthcare Systems Co., Ltd.
Institute
Department

Funding Source
Organization	Saladcosmo 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	The Ethics Committee of Healthcare Systems Co., Ltd.
Address	Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
Tel	03-6809-2722
Email	kakehashi@hc-sys.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

Other administrative information
Date of disclosure of the study information	2019 Year 09 Month 04 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	2019 Year 08 Month 20 Day
Date of IRB	2019 Year 08 Month 20 Day
Anticipated trial start date	2019 Year 09 Month 14 Day
Last follow-up date	2019 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 09 Month 04 Day
Last modified on	2020 Year 04 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043222