UMIN-CTR Clinical Trial

Basic information
Public title	A study evaluating the antihyperglycemic effect of botanical ingredient-containing food.
Acronym	A study evaluating the antihyperglycemic effect of botanical ingredient-containing food.
Scientific Title	A study evaluating the antihyperglycemic effect of botanical ingredient-containing food.
Scientific Title:Acronym	A study evaluating the antihyperglycemic effect of botanical ingredient-containing food.
Region	Japan

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

Objectives
Narrative objectives1	The objective is to evaluate the effect of botanical ingredient-containing food on glucose tolerance by Oral Glucose Tolerance Test before and after repeated intake for 4 weeks.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Area under the curve of blood glucose levels after Oral Glucose Tolerance Test
Key secondary outcomes

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	Subjects take control food for 4 weeks. Before and after repeated intake, subjects take Oral Glucose Tolerance Test to measure blood glucose levels.
Interventions/Control_2	Subjects take test food (containing botanical ingredient) for 4 weeks. Before and after repeated intake, subjects take Oral Glucose Tolerance Test to measure blood glucose levels.
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 male and female subjects whose ages are 20 <= years old <65. (2) Subjects who can visit the specified clinic on the scheduled day. (3) Subjects who agree with the given description and express informed consent via telecommunication and written documents.
Key exclusion criteria	(1) Systolic pressure <90 mmHg (2) Subjects who are pregnant or lactating. (3) Subjects who donated over 200ml blood components or whole blood within the past 4 weeks prior to the current study. (4) Male who donated over 400ml whole blood within the past 12 weeks. (5) Female who donated over 400ml whole blood within the past 16 weeks. (6) Male whose blood was collected more than 1200 mL within the last 12 months when the amount of blood sampling in the current study is added. (7) Female whose blood was collected over 800 mL within the last 12 months when the amount of blood sampling in the current study is added. (8) Subjects who are participating in other clinical studies, or who finished clinical study within the last 4 weeks. (9)Subjects a) with disease on heart, liver, kidney or other organs complications. b) with a previous history of disease on circulatory organs. c) who are contracting diabetes. d) with test food allergy. e) whose fasting blood glucose is equivalent to or higher than 140 mg/dL by a finger stick blood test. (10) Subjects who have severe allergic reaction to drug medicine and food. (11) Subjects with a previous history of feeling sick after blood sampling. (12) Subjects who have difficulty in blood sampling from peripheral vein. (13) Subjects who drink over 60 g of alcohol per day on average. (14) Subjects who have irregular eating patterns. (15) Subjects who work irregular shifts or at midnight. (16) Subjects whose BMI is less than 18.5 or over 30.0 kg/m2. (17) Subjects who are constantly taking certain drug medicine, or who are expecting taking it within the period of current study, or who have indispensable supplements, functional foods affecting the test results. (18) Subjects who are contracting atopic dermatitis and/or allergy symptoms. (19) Subjects who are judged as unsuitable for the study by the principal investigator for other reasons.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Takanori Middle name Last name Teramoto
Organization	Suntory Global Innovation Center Ltd.
Division name	Research Institute
Zip code	619-0284
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL	05031826114
Email	Takanori_Teramoto@suntory.co.jp

Public contact
Name of contact person	1st name Tomoki Middle name Last name Uchida
Organization	Suntory Global Innovation Center Ltd.
Division name	Research Institute
Zip code	619-0284
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL	05031820381
Homepage URL
Email	Tomoki_Uchida@suntory.co.jp

Sponsor
Institute	Suntory Global Innovation Center Ltd.
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Fukuhara Clinic Clinical Trial Review Committee
Address	3-1-15, Shimamatsuhigashi-machi, Eniwa-shi, Hokkaido, 061-1351 Japan
Tel	0123-36-8029
Email	d-kameda@mediffom.co.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	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 20 Day
Date of IRB	2021 Year 05 Month 17 Day
Anticipated trial start date	2021 Year 07 Month 26 Day
Last follow-up date	2021 Year 10 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	2021 Year 06 Month 09 Day
Last modified on	2022 Year 06 Month 29 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050743