UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051029 |
|---|---|
| Receipt number | R000058175 |
| Scientific Title | A Study evaluating the effect of konnyaku-derived Ninja Paste on the improvement of constipation |
| Date of disclosure of the study information | 2023/05/10 |
| Last modified on | 2023/05/10 18:24:47 |
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Basic information
Public title
A Study evaluating the effect of konnyaku-derived Ninja Paste on the improvement of constipation
Acronym
A Study evaluating the effect of konnyaku-derived Ninja Paste on the improvement of constipation
Scientific Title
A Study evaluating the effect of konnyaku-derived Ninja Paste on the improvement of constipation
Scientific Title:Acronym
A Study evaluating the effect of konnyaku-derived Ninja Paste on the improvement of constipation
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of nut bars containing konnyaku-derived Ninja Paste on the improvement of constipation and the possibility of long-term consumption
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
frequency of bowel movements
Key secondary outcomes
Volume of defecation per bowel movement, classification of stool characteristics by Bristol Scale, color of stool
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Subjects take a nut bar with Ninja Pastea for 2 weeks. After 2 weeks of washout, subjects take only nuts for 2 weeks.
Interventions/Control_2
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
| 19 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Healthy students and healthy men and women under 65 years old.
(2) Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria
1)Subjects with illness who are constantly taking certain drug medicine.
2)Subjects who have a food allergy
3)Subjects with extreme diarrhea
4)Subjects who regularly use medicines, foods for specified health uses, and health foods that may affect the study.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | TOMIYO |
| Middle name | |
| Last name | NAKAMURA |
Organization
Ryukoku University
Division name
Department of Food Science and Human Nutrition
Zip code
5202194
Address
1-5,Yokotani, Seta Oe-cho, Otsu, Shiga
TEL
077-599-5614
tomiyo@agr.ryukoku.ac.jp
Public contact
Name of contact person
| 1st name | Tomiyo |
| Middle name | |
| Last name | Nakamura |
Organization
Ryukoku University
Division name
Department of Food Science and Human Nutrition
Zip code
520
Address
1-5, Yokotani, Seta Oe-cho Otsu
TEL
077-599-5614
Homepage URL
tomiyo@agr.ryukoku.ac.jp
Sponsor or person
Institute
Ryukoku University
Institute
Department
Personal name
Tomiyo Nakamura
Funding Source
Organization
Sydecas Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
HAGOROMO University of International Studies
Name of secondary funder(s)
Kansai Mirai Bank, Limited
IRB Contact (For public release)
Organization
Rytukoku University Ethics Committee
Address
1-5, Yokotani, Seta Oe-cho Otsu
Tel
077-543-7742
setaken@ad.ryukoku.ac.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
龍谷大学・羽衣国際大学
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 05 | Month | 10 | 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
150
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 01 | Month | 16 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 24 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 14 | Day |
Date of closure to data entry
| 2023 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 05 | Month | 10 | Day |
Last modified on
| 2023 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058175
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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