UMIN-CTR Clinical Trial

Basic information
Public title	A study for safety evaluation of 12-weeks consumption of the drink containing indigestible dextrin.
Acronym	A study for safety evaluation of 12-weeks consumption of the drink containing indigestible dextrin.
Scientific Title	A study for safety evaluation of 12-weeks consumption of the drink containing indigestible dextrin.
Scientific Title:Acronym	A study for safety evaluation of 12-weeks consumption of the drink containing indigestible dextrin.
Region	Japan

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

Objectives
Narrative objectives1	Safety evaluation of 12-weeks consumption of the drink which contain indigestible dextrin.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The incidence of side effects
Key secondary outcomes	Blood test Urine test Blood pressure/pulsation Weight/body mass index Medical interview

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Drink which is contain indigestible dextrin 5g as dietary fiber. Intake 350mL/day, 12 weeks.
Interventions/Control_2	Drink which is not contain indigestible dextrin. Intake 350mL/day, 12 weeks.
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)Subjects giving written informed consent (2)Healthy males and females aged 20 to 64 years old. (3) Subjects who falls under any of the following criteria. A. Fasting blood glucose levels at preliminary test are less than 100mg/dL. (around 18 subjects) B. Fasting blood glucose levels at preliminary test are between more than 100mg/dL and less than 126mg/dL. (around 12 subjects)
Key exclusion criteria	(1)Subjects who are given continuous treatment by taking medicines. (2) Subjects who constantly use oral medicines, functional foods and/or supplements having a possibility of affecting test results. (3)Subjects who have previous and/or current medical history of serious disease (e.g., heart, liver, kidney, digestive organ). (4) Females who are pregnant or lactating, and females who could become pregnant or lactating during test period. (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 have previous medical history of drug and/or food allergy. (8) 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. (9)Subjects who donated over 200mL blood and/or blood components within the last one month to the current study. (10) Subjects who donated over 400mL blood and/or blood components within the last three month to the current study. (11) Females who donated over 400mL blood and/or blood components within the last four month to the current study. (12) Males who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study. (13) Females who will be collected over 800mL blood and/or blood components when, the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study. (14)Others who have been determined ineligible by principal investigator or sub-investigator.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Katsuhisa Sakano
Organization	CPCC Company Limited
Division name	Clinical Research Planning Department
Zip code
Address	4F Chushin Build. 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047 Japan
TEL	03-5297-3112
Email	k.s@cpcc.co.jp

Public contact
Name of contact person	1st name Middle name Last name Makoto Ichinohe
Organization	CPCC Company Limited
Division name	Plan Sales Department
Zip code
Address	4F Chushin Build. 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047 Japan
TEL	03-5297-3112
Homepage URL
Email	m.i@cpcc.co.jp

Sponsor
Institute	CPCC Company Limited
Institute
Department

Funding Source
Organization	ASAHI BREWERIES, 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
Address
Tel
Email

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	2015 Year 07 Month 29 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	2015 Year 07 Month 21 Day
Date of IRB
Anticipated trial start date	2015 Year 07 Month 29 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 07 Month 28 Day
Last modified on	2015 Year 12 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021358

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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