UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019290 |
|---|---|
| Receipt number | 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 11:15:23 |
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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
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
Yoko_Yasutake@suntory.co.jp
Sponsor or person
Institute
Suntory Business Expert Limited
Institute
Department
Personal name
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
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
Value
https://center6.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 |
