UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025944 |
|---|---|
| Receipt number | R000029828 |
| Scientific Title | A verification study of influence on defecation by consumption of the polydextrose-containing food for adult male and female with constipation tendency |
| Date of disclosure of the study information | 2017/02/05 |
| Last modified on | 2020/10/05 18:20:48 |
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Basic information
Public title
A verification study of influence on defecation by consumption of the polydextrose-containing food for adult male and female with constipation tendency
Acronym
Verification of influence on defecation by consumption of the polydextrose-containing food
Scientific Title
A verification study of influence on defecation by consumption of the polydextrose-containing food for adult male and female with constipation tendency
Scientific Title:Acronym
Verification of influence on defecation by consumption of the polydextrose-containing food
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Confirm the effect on defecation by ingesting the polydextrose containing food for males and females with subjective symptoms of constipation tendency.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of defecation (days of defecation)
Key secondary outcomes
*Feces property (amount, shape, color, smell, sensation after defecation)
*Intestinal microflora
*Physicochemical analysis of feces (
fecal organic acid, fecal decay products)
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
Intake 2 packs of test food in a day at any time for 2 weeks. Keep interval minimum 6 hrs between test foods intake.
Interventions/Control_2
Intake 2 packs of control food in a day at any time for 2 weeks. Keep interval minimum 6 hrs between control foods intake.
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Males and females aged 20 to 59 years old.
(2) Subjects who defecate 2 to 4 times in a week.
(3) Subjects who show understanding of the study procedures and agreement with participating the study by written informed consent prior to the study.
Key exclusion criteria
(1)Subjects who are diagnosed as a strong constipation by a doctor.
(2)Subjects who are diagnosed with diabetes (including boundary type) by a doctor.
(3)Subjects who regularly use medical drugs and/or supplements that have bowel movement improving effect.
(4)Pregnant or expected pregnant women, or lactating women.
(5)Subjects who have previous and/or current medical history of serious disease in heart, liver, kidney and/or digestive trucks.
(6)Subjects who excessive alcohol intake.
(7)Subjects who have extremely irregular life rhythm, and subjects who have midnight work or irregular shift work.
(8)Subjects who have previous medical history of drug and/or food allergy.
(9)Subjects who are participating the other clinical tests of medicines or foods. Subjects who participated other clinical tests of medicines or foods within 4-weeks prior to the current study. Subjects who are planning to participate in other clinical tests of medicines or foods after agreeing with participating in this study. (10)Subjects who donated over 200mL blood and/or blood components within the last one month to the current study.
(11)Males who donated over 400mL blood within the last three month to the current study.
(12) Females who donated over 400mL blood within the last four month to the current study.
(13) Males who will be collected over 1200mL blood, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study.
(14) Females who will be collected over 800mL blood, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study.
(15)Others who have been determined ineligible by principal investigator or sub-investigator.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Katsuhisa |
| Middle name | |
| Last name | Sakano |
Organization
CPCC Company Limited
Division name
Clinical Research Planning Department
Zip code
101-0047
Address
4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL
03-5297-3112
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Numa |
Organization
CPCC Company Limited
Division name
Sales & Planning Department
Zip code
101-0047
Address
4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL
03-5297-3112
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Factory, Inc.
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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Chushin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan
Tel
03-5297-5548
IRB@cpcc.co.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
| 2017 | Year | 02 | Month | 05 | 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
| 2017 | Year | 01 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 06 | 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
| 2017 | Year | 02 | Month | 01 | Day |
Last modified on
| 2020 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029828
