UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018446
Receipt number R000021358
Scientific Title A study for safety evaluation of 12-weeks consumption of the drink containing indigestible dextrin.
Date of disclosure of the study information 2015/07/29
Last modified on 2015/12/24 08:10:00

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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 or person

Institute

CPCC Company Limited

Institute

Department

Personal name



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

Value
https://center6.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