UMIN-CTR Clinical Trial

Basic information
Public title	A confirmation study of the inhibitory effect of blood glucose increasing by consumption of the test drink
Acronym	A confirmation study of the inhibitory effect of blood glucose increasing by consumption of the test drink
Scientific Title	A confirmation study of the inhibitory effect of blood glucose increasing by consumption of the test drink
Scientific Title:Acronym	A confirmation study of the inhibitory effect of blood glucose increasing by consumption of the test drink
Region	Japan

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

Objectives
Narrative objectives1	To confirm the elevation inhibitory effect of blood glucose and of blood triglyceride by consumption of the test drink.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	*Area under the concentration time curve of blood glucose *Area under the concentration time curve of blood insulin
Key secondary outcomes	*Area under the concentration time curve of blood triglyceride *Blood glucose level of each measuring point *Blood insulin level of each measuring point *Blood triglyceride level of each measuring point *Cmax of blood glucose level *Tmax of blood glucose level *Cmax of blood insulin level *Tmax of blood insulin level *Cmax of blood triglyceride level *Tmax of blood triglyceride level *The incidence of side effects and/or adverse events

Base
Study type	Interventional

Study design
Basic design	Cross-over
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	Consume one bottle (50 mL) of test drink 5 min before the load food intake. Rest more than 5 days. Consume one bottle (50 mL) of control drink 5 min before the load food intake.
Interventions/Control_2	Consume one bottle (50 mL) of control drink 5 min before the load food intake. Rest more than 5 days. Consume one bottle (50 mL) of test drink 5 min before the load food intake.
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	64 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Male and Females aged 20 to 64 when informed consent. 2) Subjects their fasting blood glucose are between 110 and 125 mg/dL or their blood glucose level of 120 min after OGTT are between 140 and 199 mg/dL. 3) Subjects who receive enough explain of the test, who deeply understanding of the test, and who obtain own consent to participate the test.
Key exclusion criteria	1) Subjects who are being received treatment and/or medication when informed consent. 2) Subjects who are not able to quit intake medicine, food for specific health, functional food and/or supplement having a possibility of affecting blood glucose level during test period. 3) Females who are pregnant or lactating, and females who could become pregnant or lactating during test period. 4) Subjects who have previous and/or current medical history of serious disease (e.g., heart, liver, kidney, digestive organ). 5) Subjects who excessive alcohol intake. 6) Subjects who have extremely irregular dining habits, and subjects who have midnight work or irregular shift work. 7) Subjects who excessive alcohol intake. 8) Subjects who have weak digestive organ and/or have tendency of diarrhea. 9) Subjects who show more than 6.5 % in HbA1c level at preliminary test. 10) Subjects who show more than 160 mg/dL in fasting blood glucose level measured by glucose sensor at preliminary test. 11) Subjects who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests. 12) Subjects who donated over 200 mL blood and/or blood components within the last one month to the current study. 13) Subjects who donated over 400mL blood and/or blood components within the last three months to the current study. 14) Females who donated over 400mL blood and/or blood components within the last four months to the current study. 15) Males who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last twelve months are adding to the planned sampling amounts of this study. 16) Females who will be collected over 800mL blood and/or blood components when, the sampling amounts within the last twelve months are adding to the planned sampling amounts of this study. 17) Others they have been determined ineligible by principal investigator or sub-investigator.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Suguru Middle name Last name Fujiwara
Organization	CPCC Company Limited
Division name	Division of Clinical Research
Zip code	101-0047
Address	4F Sanwauchikannda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL	03-5297-3112
Email	cpcc-contact@cpcc.co.jp

Public contact
Name of contact person	1st name Masanori Middle name Last name Numa
Organization	CPCC Company Limited
Division name	Planning & Sales Department
Zip code	101-0047
Address	4F Sanwauchikannda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL	03-5297-3112
Homepage URL
Email	cpcc-contact@cpcc.co.jp

Sponsor
Institute	CPCC Company Limited
Institute
Department

Funding Source
Organization	Mannanlife 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	Institutional Review Board of Chiyoda Paramedical Care Clinic
Address	2F Sanwauchikannda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan
Tel	03-5297-5548
Email	IRB@cpcc.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	2020 Year 06 Month 09 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	10
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 05 Month 17 Day
Date of IRB	2019 Year 05 Month 17 Day
Anticipated trial start date	2019 Year 06 Month 09 Day
Last follow-up date	2019 Year 07 Month 13 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 06 Month 06 Day
Last modified on	2020 Year 10 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042129

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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