UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037061 |
|---|---|
| Receipt number | R000042227 |
| Scientific Title | Study for influence of long-term intake of pineapple on improvement in intestinal environment for children |
| Date of disclosure of the study information | 2019/06/13 |
| Last modified on | 2019/12/12 09:13:28 |
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Basic information
Public title
Study for influence of long-term intake of pineapple on improvement in intestinal environment for children
Acronym
Study for influence of long-term intake of pineapple on improvement in intestinal environment for children
Scientific Title
Study for influence of long-term intake of pineapple on improvement in intestinal environment for children
Scientific Title:Acronym
Study for influence of long-term intake of pineapple on improvement in intestinal environment for children
Region
| Japan |
Condition
Condition
Healthy Children
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify effect of long-term intake intervention of pineapple for children on intestinal environment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intestinal bacterial flora before and after intake of 4 weeks
Key secondary outcomes
Questionnaire on defecation
Urine test (Indoxyl sulfate)
before and after intake of 4 weeks
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake 100g of pineapple per day.
Interventions/Control_2
none
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
| 6 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Those who receive written consent from parents who fully understand the purpose and contents of this study
2.Healthy Japanese those who are 6 to 12 years old at the time of consent acquisition
3.Those who defecate 2 to 4 times a week
Key exclusion criteria
1.Those who have a chronic disease and are undergoing medication, those with a serious disease history
2.Those who are allergic to the test food
3.Those who have never taken a pineapple in the past
4.Those who have participated in other tests within the first month before the start of the exam, or who are planning to participate in other exams after this exam consent
5.Those who are judged ineligible at the examination doctor and research leader
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takamasa |
| Middle name | |
| Last name | Masuda |
Organization
Healthcare Systems Co., Ltd.
Division name
Research and Development Department
Zip code
1050004
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
03-6809-2722
masudat@hc-sys.jp
Public contact
Name of contact person
| 1st name | Takamasa |
| Middle name | |
| Last name | Masuda |
Organization
Healthcare Systems Co., Ltd
Division name
Research and Development Department
Zip code
1050004
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
03-6809-2722
Homepage URL
masudat@hc-sys.jp
Sponsor or person
Institute
Healthcare Systems Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
SOLROS 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
Healthcare Systems Ethics Committee
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
Tel
03-6809-2722
kakehashi@hc-sys.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
| 2019 | Year | 06 | Month | 13 | 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
| 2019 | Year | 06 | Month | 13 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 28 | 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 | 13 | Day |
Last modified on
| 2019 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042227
