UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058544 |
|---|---|
| Receipt number | R000066909 |
| Scientific Title | Study on the effect of dietary fiber processed foods on improving bowel movements in people prone to constipation -Placebo-controlled randomized double-blind crossover method- |
| Date of disclosure of the study information | 2025/08/01 |
| Last modified on | 2025/07/22 13:06:33 |
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Basic information
Public title
Study on the effect of dietary fiber processed foods on improving bowel movements in people prone to constipation
-Placebo-controlled randomized double-blind crossover method-
Acronym
Study on the effect of dietary fiber processed foods on improving bowel movements in people prone to constipation
Scientific Title
Study on the effect of dietary fiber processed foods on improving bowel movements in people prone to constipation
-Placebo-controlled randomized double-blind crossover method-
Scientific Title:Acronym
Study on the effect of dietary fiber processed foods on improving bowel movements in people prone to constipation
Region
| Japan |
Condition
Condition
Healthy adults with a tendency toward constipation
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Confirm whether bowel movements improve in healthy adults with a tendency toward constipation when they consume dietary fiber processed foods.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
defecation frequency
Key secondary outcomes
1)Defecation days
2)Amount of stool
3)Shape of stool
4)Color of stool
5)Smell of stool
6)Feeling after bowel movement
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Consume test food for 14 days -> 14-day break -> Consume control food for 14 days
Interventions/Control_2
Consume control food for 14 days -> 14-day break -> Consume test food 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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Japanese men and women aged 20 to 60 who had 3 to 5 bowel movements per week according to the research subject diary submitted at the time of the screening test.
2)Those who normally eat three meals a day.
3)Those who have received sufficient explanation about the purpose and content of the study, have the capacity to consent, have a good understanding of the study, have voluntarily applied to participate, and have agreed to participate in this study in writing.
Key exclusion criteria
1)Those who regularly use laxatives or constipation medications (including purgatives).
2)Those with severe liver, kidney, gastrointestinal, heart, respiratory, endocrine, thyroid, or adrenal disease, or other metabolic disorders.
3)Those diagnosed with irritable bowel syndrome (IBS) or inflammatory bowel disease (IBD).
4)Those with a history of digestive tract diseases that affect digestion, absorption, or bowel movements, or a history of surgery.
5)Those with a history of or currently suffering from drug or alcohol dependence.
6)Those who cannot refrain from consuming foods containing live bacteria (e.g., lactobacillus, bifidobacteria, natto bacteria), foods enriched with oligosaccharides or dietary fiber, fermented foods, or foods containing large amounts of sugar alcohols during the study period.
7)Those who regularly take supplements claimed to improve constipation (including specific health use foods and functional foods) at the time of screening.
8)Those who have taken antibiotics or other medications that affect digestion and absorption within two weeks of screening.
9)Those with a habit of consuming excessive amounts of alcohol exceeding 40g of pure alcohol per day.
10)Shift workers or night shift workers.
11)Those deemed unsuitable as study participants based on the results of the study participant background questionnaire.
12)Pregnant those, those intending to become pregnant during the study period, or breastfeeding those.
13)Those who have undergone blood draws exceeding 200mL within one month or 400mL within three months prior to the date of informed consent.
14)Those currently participating in or intending to participate in studies involving the consumption of other foods, the use of medications, or the application of cosmetics or medications.
15)Other those deemed inappropriate as study participants by the principal investigator.
Target sample size
56
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Iwama |
Organization
Nihonbashi Cardiology Clinic
Division name
Director
Zip code
103-0004
Address
Anera Bldg. 8F, 3-3-3 Higashi Nihonbashi, Chuo-ku, Tokyo
TEL
03-5641-4133
yiwama@well-sleep.jp
Public contact
Name of contact person
| 1st name | Yoshika |
| Middle name | |
| Last name | Komori |
Organization
KSO Corporation
Division name
Clinical Trial Management department
Zip code
105-0023
Address
1-9-7, Shibaura, Minato-ku, Tokyo The 7th floor of Shibaura omodaka building
TEL
03-3452-7733
Homepage URL
eigyou27@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
Kobayashi Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Kobuna Orthopedics Clinic
Address
5-656-17 Joto-machi, Maebashi-shi, Gunma
Tel
027-212-5608
sagawa@mc-connect.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
医療法人財団健康睡眠会 日本橋循環器内科クリニック
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 01 | 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 | 07 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 03 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 07 | Month | 22 | Day |
Last modified on
| 2025 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066909
