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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019290
Receipt No. R000022310
Scientific Title A study of excessive consumption of beverage containing dietary fiber. -randomized, double-blind, placebo-controlled, parallel-group study.
Date of disclosure of the study information 2015/10/11
Last modified on 2017/12/08

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Basic information
Public title A study of excessive consumption of beverage containing dietary fiber. -randomized, double-blind, placebo-controlled, parallel-group study.
Acronym A study of excessive consumption of beverage containing dietary fiber.
Scientific Title A study of excessive consumption of beverage containing dietary fiber. -randomized, double-blind, placebo-controlled, parallel-group study.
Scientific Title:Acronym A study of excessive consumption of beverage containing dietary fiber.
Region
Japan

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

Objectives
Narrative objectives1 To evaluate safety of excessive consumption of beverage containing dietary fiber.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes ADR
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 Excessive consumption of beverage containing dietary fiber
Interventions/Control_2 Excessive consumption of beverage not containing dietary fiber
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

Not applicable
Gender Male and Female
Key inclusion criteria 1)20 years of age or older.
2)Understanding the study and submitting the written informed consent before the study.
Key exclusion criteria 1)With diabetes mellitus or glucose metabolism disorder.
2)Females in pregnancy, lactation and scheduled pregnancy period.
3)With heart disorder liver disorder, and kidney disorder
4)With previous or present cardiac disorder.
5)With allergy to drugs or foods.
6)Investigator's judgment for other reason.
Target sample size 48

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshinori Kitagawa
Organization Suntory Business Expert Limited
Division name Quality Assurance Division
Zip code
Address 8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL 050-3182-0339
Email Yoshinori_Kitagawa@suntory.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoko Yasutake
Organization Suntory Business Expert Limited
Division name Quality Assurance Division
Zip code
Address 8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL 050-3182-0366
Homepage URL
Email Yoko_Yasutake@suntory.co.jp

Sponsor
Institute Suntory Business Expert Limited
Institute
Department

Funding Source
Organization Suntory Beverage & Food Limited
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 10 Month 11 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
Twenty-four subjects were assigned to each of the test group and the control group, and all participants were completed.
No adverse effect related to the food were observed in either group.
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 10 Month 08 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 31 Day
Last follow-up date
2015 Year 11 Month 28 Day
Date of closure to data entry
Date trial data considered complete
2015 Year 12 Month 07 Day
Date analysis concluded
2016 Year 01 Month 29 Day

Other
Other related information

Management information
Registered date
2015 Year 10 Month 09 Day
Last modified on
2017 Year 12 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022310

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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