UMIN-CTR Clinical Trial

Basic information
Public title	A study evaluating the effect of botanical ingredient-containing food on parameters of glucose metabolism.
Acronym	A study evaluating the effect of botanical ingredient-containing food on parameters of glucose metabolism.
Scientific Title	A study evaluating the effect of botanical ingredient-containing food on parameters of glucose metabolism.
Scientific Title:Acronym	A study evaluating the effect of botanical ingredient-containing food on parameters of glucose metabolism.
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 parameters of glucose metabolism after repeated intake for 12 weeks.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	HbA1c
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	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Subjects take control food for 12 weeks. Before and after repeated intake, subjects take blood sampling.
Interventions/Control_2	Subjects take test food 1 (containing botanical ingredient) for 12 weeks. Before and after repeated intake, subjects take blood sampling.
Interventions/Control_3	Subjects take test food 2 (containing botanical ingredient) for 12 weeks. Before and after repeated intake, subjects take blood sampling.
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 written documents. (4) Subjects whose HbA1c is equal to or more than 5.6 % and less than 6.5 %.
Key exclusion criteria	(1) Systolic pressure <90 mmHg (2) pregnant or lactating. (3) donated over 200ml blood components or whole blood within the past 4 weeks. (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 more than 800 mL within the last 12 months when the amount of blood sampling in the current study is added. (8) 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) contracting diabetes. d) with test food allergy. (10) Who have possibility to be diagnosed as diabetes; whose fasting blood glucose is equal to or more than 126 mg/dL, or whose blood glucose level during the 75g OGTT is equivalent to or more than 200 mg/dL at 120 min., or whose HbA1c is equal to or more than 6.5 %. (11) with severe allergic reaction to drug medicine and food. (12) with a previous history of feeling sick after blood sampling. (13) Who have difficulty in blood sampling from peripheral vein. (14) Who drink alcohol a lot (over 60 g of alcohol per day on average). (15) Who have irregular eating patterns. (16) Who work irregular shifts or at midnight. (17) constantly taking certain drug medicine, or expecting taking it within the period of current study, or indispensable supplements, functional foods (including Food for Specified Health Uses) affecting the test results. (18) whose BMI is less than 18.5 or equal to or more than 30.0 kg/m2. (19) contracting atopic dermatitis and/or allergy symptoms. (20) contracting alcohol hypersensitivity. (21) judged as unsuitable for the study by the principal investigator for other reasons.
Target sample size	135

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	619-0238
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL	050-3182-6114
Email	Takanori_Teramoto@suntory.co.jp

Public contact
Name of contact person	1st name Shinya Middle name Last name Fukizawa
Organization	Suntory Global Innovation Center Ltd.
Division name	Research Institute
Zip code	619-0238
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL	050-3182-6114
Homepage URL
Email	Takanori_Teramoto@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	The ethics committees of Yoga Allergy Clinic
Address	4-32-16, Yoga, Setagaya-ku, Tokyo, Japan
Tel	03-5491-4478
Email	info@yg-allergy.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

Other administrative information
Date of disclosure of the study information	2022 Year 06 Month 17 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	Preinitiation
Date of protocol fixation	2022 Year 06 Month 10 Day
Date of IRB
Anticipated trial start date	2022 Year 06 Month 25 Day
Last follow-up date	2023 Year 01 Month 16 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 06 Month 13 Day
Last modified on	2022 Year 06 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054753

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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