UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058690 |
|---|---|
| Receipt number | R000066211 |
| Scientific Title | Evaluation of the Effect of Study Food Consumption on Bowel Movement Frequency |
| Date of disclosure of the study information | 2025/08/29 |
| Last modified on | 2025/07/01 14:26:27 |
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Basic information
Public title
Evaluation of the Effect of Study Food Consumption on Bowel Movement Frequency
Acronym
Evaluation of the Effect of Study Food Consumption on Bowel Movement Frequency
Scientific Title
Evaluation of the Effect of Study Food Consumption on Bowel Movement Frequency
Scientific Title:Acronym
Evaluation of the Effect of Study Food Consumption on Bowel Movement Frequency
Region
| Japan |
Condition
Condition
Male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of consuming the study food for two weeks on bowel movement frequency.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bowel movement frequency
Key secondary outcomes
Total fecal short-chain fatty acids (sum of acetic acid, propionic acid, and n-butyric acid)
Fecal organic acids (acetic acid, propionic acid, n-butyric acid, iso-butyric acid, lactic acid, succinic acid, n-valeric acid, iso-valeric acid, 2-methylvaleric acid, 4-methylvaleric acid, caproic acid, malonic acid, formic acid)
Moisture content in the stool
Stool pH
Amount of ammonia in the stool
Amount of putrefactive products in the stool
Gut microbiota composition
Bowel movement conditions (number of days of defecation, amount of stool, stool consistency, stool color, feeling of residual stool at the time of defecation, and odor)
CAS-MT (Constipation assessment scale middle term)
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
Oral consumption of one test food, once daily for 14 days
Interventions/Control_2
Oral consumption of one placebo food, once daily for 14 days
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. Male and female aged 20 to below 65 years at the time of consent acquisition.
2. Individuals with a bowel movement frequency of five times or fewer per week.
3. Individuals who are able to receive the study food once a week.
4. Individuals able to consume one unit of the study food per day.
5. Individuals who are able to give informed consent to participate in this study after receiving a detailed explanation of the protocol and understanding its contents.
Key exclusion criteria
1. Individuals who consume Foods for Specified Health Uses, Foods with Function Claims, or other health foods or supplements that may affect the intestinal environment more than twice a week.
Individuals who consume such products once a week or less but are unable to discontinue their use from the time of consent acquisition.
2. Individuals who consume yogurt, lactic acid bacteria drinks, or staple foods high in dietary fiber (e.g., brown rice, barley, whole-grain bread, cereals, and foods with nutritional claims that are not classified as Foods for Specified Health Uses or Foods with Function Claims) more than three times a week
3. Individuals who consume alcohol more than three times per month or who consume more than 60 g of alcohol per drinking occasion.
4. Individuals who had days with fewer than 1 meal per day more than once a week within 1 month before the preliminary examination.
5. Individuals on carbohydrate-restricted or weight-loss diets.
6. Individuals with extremely irregular lifestyles (e.g., night shift workers or those with irregular rotating shifts).
7. Individuals with a BMI of 30.0 kg/m2 or higher.
8. Individuals who plan to change their current lifestyle, dietary habits, or living environment (e.g., moving, job transfers, overseas travel or business trips) during the study period.
9. Individuals who are participating in, have participated in within the four weeks prior to the current trial, or are planning to participate in clinical trials of pharmaceuticals or health foods.
10. Individuals whose cohabiting family members are also scheduled to participate in this study.
11. Individuals with a history of appendectomy.
Target sample size
76
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 | Masanori |
| Middle name | |
| Last name | Numa |
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
0362259001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Nisshin Seifun Group 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 Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
0362259005
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
| 2025 | Year | 08 | Month | 29 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 05 | Month | 19 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 25 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(Exclusion criteria continued)
12. Individuals who have undergone surgeries that could affect the study within six months prior to consent acquisition (e.g., colonoscopy, gallstone or gallbladder removal, or gastric bypass surgery).
13. Individuals who have taken, or plan to take during the study period, medications that may affect the intestinal environment (e.g., antibiotics, probiotics, laxatives, proton pump inhibitors) within one month before the preliminary examination.
14. Individuals currently undergoing pharmacological treatment or dietary therapy.
15. Individuals with previous and/or current medical history of serious diseases in the heart, liver, kidney, digestive organs.
16. Females who are pregnant, breastfeeding, or intending to become pregnant during trial period.
17. Individuals with allergies to pharmaceuticals or foods.
18. Individuals who have donated blood components or 200 mL of whole blood within 1 month before the start of the trial.
19. Men who have donated 400 mL of whole blood within 3 months before the start of the trial.
20. Women who have donated 400 mL of whole blood within 4 months before the start of the trial.
21. Men whose total blood donation volume >1200 mL within 12 months before the start of the trial when the planned total blood sampling volume for the study is added.
22. Women whose total blood donation volume exceeds 800 mL within 12 months before the start of the trial when the planned total blood sampling volume for the study is added.
23. Individuals judged by the principal investigator or subinvestigator to be inappropriate to participate in this trial.
Management information
Registered date
| 2025 | Year | 08 | Month | 04 | Day |
Last modified on
| 2025 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066211
