UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055374 |
|---|---|
| Receipt number | R000063107 |
| Scientific Title | Evaluation of the Effects of a 4-Week Consumption of Test Food on Bowel Movement Improvement (B) |
| Date of disclosure of the study information | 2024/08/30 |
| Last modified on | 2025/11/25 16:26:18 |
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Basic information
Public title
Evaluation of the Effects of a 4-Week Consumption of Test Food on Bowel Movement Improvement (B)
Acronym
Evaluation of the Effects of a 4-Week Consumption of Test Food on Bowel Movement Improvement (B)
Scientific Title
Evaluation of the Effects of a 4-Week Consumption of Test Food on Bowel Movement Improvement (B)
Scientific Title:Acronym
Evaluation of the Effects of a 4-Week Consumption of Test Food on Bowel Movement Improvement (B)
Region
| Japan |
Condition
Condition
Male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the intestinal regulatory effects and prebiotic effects of the test food.
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
Bowel movement conditions (stool consistency, abdominal symptoms)
Gut microbiota composition
Gut metabolites
Intestinal barrier markers
Profile of Mood States 2nd Edition (POMS2) Short Form
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
Consumption of the test food (1 sachet, once daily) for 4 weeks
Interventions/Control_2
Consumption of the placebo food (1 sachet, once daily) for 4 weeks
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Japanese men and women aged 20 to below 65 years at the time of consent acquisition.
2. Subjects who have had an average bowel movement frequency of 5 times or less per week for the two months prior to consent acquisition.
3. Subjects who can give informed consent to partake in this study, after being provided with an explanation of the protocol detail.
Key exclusion criteria
1. Subjects who consume Foods for Specified Health Uses (FOSHU), Foods with Functional Claims, or health supplements (including those with effects on intestinal regulation, probiotics, or prebiotics) three or more times per week that could potentially affect the study.
2. Subjects who cannot stop consuming Foods for Specified Health Uses (FOSHU), Foods with Functional Claims, or health supplements (including those with effects on intestinal regulation, probiotics, or prebiotics) that could potentially affect the study from the time of consent acquisition.
3. Subjects who have taken medications that could affect the study (such as antibiotics, intestinal regulators, or laxatives) within one month before consuming the study food, or those who plan to take such medications during the study period.
4. Subjects who cannot abstain from alcohol from the day before the preliminary examination or each test.
5. Subjects with excessive alcohol intake.
6. Smokers or Subjects who have quit smoking within the last six months.
7. Subjects with gastrointestinal diseases or a history of gastrointestinal surgery (excluding hemorrhoid surgery) that could affect digestion and absorption.
8. Subjects currently taking medication for lifestyle-related diseases or other treatments.
9. Subjects receiving medical treatments such as dialysis, exercise therapy, or dietary therapy.
10. Subjects with irregular life rhythms (such as shift workers or night shift workers).
11. Subjects planning to travel or move for 3 nights and 4 days or more during the study period.
12. Subjects who are participating in the other clinical trials and/or who have participated in the other clinical trials within 4 weeks prior to the current trial and/or who are planning to participate in the other clinical trials.
13. Females who are pregnant or lactating, and females who could become pregnant during trial period.
14. Subjects with self-reported irritable bowel syndrome (IBS).
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Fumiko |
| Middle name | |
| Last name | Nakamura |
Organization
CPCC Company Limited
Division name
Clinical Support Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan
TEL
03-6225-9001
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ichinohe |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan
TEL
03-6225-9001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Meiji 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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
03-6225-9005
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
| 2024 | Year | 08 | Month | 30 | 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
50
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
| 2024 | Year | 08 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 02 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(Exclusion criteria continued)
15. Subjects who are aware of experiencing excessive abdominal symptoms (such as severe diarrhea or bloating) when consuming oligosaccharides.
16. Subjects with allergies to food.
17. Subjects who donated blood or component (200 mL) within the last 1 months.
18. Subjects who donated his blood (400 mL) within the last 3 months.
19. Subjects who donated her blood (400 mL) within the last 4 months.
20. Subjects who being collected in total of his blood (1200 mL) within the last 12 months and in this study.
21. Subjects who being collected in total of her blood (800 mL) within the last 12 months and in this study.
22. Subjects deemed unsuitable for participation in the trial by the principal investigator or sub-investigator.
Management information
Registered date
| 2024 | Year | 08 | Month | 30 | Day |
Last modified on
| 2025 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063107
