UMIN-CTR Clinical Trial

Basic information
Public title	Effects of consumption of the test food containing banaba extract on fasting blood glucose level, and a verification study for safety evaluation of excessive the test food ingestion in healthy Japanese subjects: a randomized, double-blind, placebo-controlled, parallel-group trial
Acronym	Effects of consumption of the test food containing banaba extract on fasting blood glucose level, and a verification study for safety evaluation of excessive the test food ingestion
Scientific Title	Effects of consumption of the test food containing banaba extract on fasting blood glucose level, and a verification study for safety evaluation of excessive the test food ingestion in healthy Japanese subjects: a randomized, double-blind, placebo-controlled, parallel-group trial
Scientific Title:Acronym	Effects of consumption of the test food containing banaba extract on fasting blood glucose level, and a verification study for safety evaluation of excessive the test food ingestion
Region	Japan

Condition
Condition	Healthy Japanese subjects
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the effects of consumption of the test food containing banaba extract for 8 weeks on the fasting blood glucose level in healthy Japanese subjects. To identify the safety of excessive consumption of the test food for 4 weeks in healthy Japanese subjects.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1. Fasting blood glucose level * Measure the values at screening (before consumption) and 8 and 12 weeks after consumption and calculate the amount of change.
Key secondary outcomes	1. Hemoglobin A1c (HbA1c) level 2. Serum glycoalbumin level 3. Serum insulin level 4. Plasma pentosidine 5. Vascular age 6. Vascular age score 7. Value of Schirmer's test (right eye, left eye, the average in both eyes, dominant eye, and non-dominant eye) *1-7 Measure the values at screening (before consumption) and 8 and 12 weeks after consumption and calculate the amount of change. *5,6 Measure the items by Medical Analyzer. *7 Measure the item by Schirmer tear test strips. <Safety evaluation items> 1. Physical examination 2. Urinalysis 3. Blood test *1-3 Measure the values at 8 and 12 weeks after consumption and calculate the amount of change. *2 Measure the values at 8 and 12 weeks after consumption.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Duration: 12 weeks Test material: Tablet containing banaba extract [from the starting date to intake through the examination at 8 weeks after consumption] Dose: Take 2 tablets per day Administration: Take 2 tablets with water or warm water after breakfast [from the examination at 8 weeks after consumption through the examination at 12 weeks after consumption] Dose: Take 10 tablets per day Administration: Take 10 tablets any time during the day with water or warm water * If you forget to take tablets, take these as soon as you remember within the day.
Interventions/Control_2	Duration: 12 weeks Test material: Placebo tablet <from the starting date to intake through the examination at 8 weeks after consumption> Dose: Take 2 tablets per day Administration: Take 2 tablets with water or warm water after breakfast <from the examination at 8 weeks after consumption through the examination at 12 weeks after consumption> Dose: Take 10 tablets per day Administration: Take 10 tablets any time during the day with water or warm water * If you forget to take tablets, take these as soon as you remember within the 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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Healthy Japanese adult subjects who are anxious in blood glucose level 2. Subjects who are judged as eligible to participate in the study by the physician 3. Within the subjects who met the 1st and 2nd inclusion criteria, subjects between 110 mg/dL or more and 125 mg/dL or less in fasting blood glucose at screening (before consumption) 4. When a number of subjects who passed the inclusion criteria are below the sample size, select those whose fasting blood glucose levels are in a relatively high normal range (less than 110 mg/dL)
Key exclusion criteria	1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, myocardial infarction 2. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 3. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily *Particularly taking food/beverage effective in lowering blood sugar in daily 4. Subjects who are currently taking medications (including herbal medicines) and supplement *Particularly taking antihypertensive drugs in daily 5. Subjects who are allergic to medicines and/or the test food related products 6. Subjects who are pregnant, breast-feeding, or planning to become pregnant 7. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial 8. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size	32

Research contact person
Name of lead principal investigator	1st name Kazuo Middle name Last name YAMAMOTO
Organization	ORTHOMEDICO Inc.
Division name	CEO
Zip code	112-0002
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL	03-3818-0610
Email	kazu@orthomedico.jp

Public contact
Name of contact person	1st name Naoko Middle name Last name SUZUKI
Organization	ORTHOMEDICO Inc.
Division name	R&D Department
Zip code	112-0002
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL	03-3818-0610
Homepage URL
Email	nao@orthomedico.jp

Sponsor
Institute	ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization	TOKIWA PHYTOCHEMICAL Co., Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Medical Corporation Seishinkai, Takara Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address	9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel	03-5793-3623
Email	info@takara-clinic.com

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	医療法人社団盛心会 タカラクリニック (東京都) Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

Other administrative information
Date of disclosure of the study information	2018 Year 07 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	32
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	2018 Year 07 Month 09 Day
Date of IRB	2018 Year 07 Month 09 Day
Anticipated trial start date	2018 Year 07 Month 19 Day
Last follow-up date	2019 Year 01 Month 12 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 07 Month 18 Day
Last modified on	2019 Year 12 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038112