UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058588 |
|---|---|
| Receipt number | R000066943 |
| Scientific Title | A Study on the Effects of the Test Food on Intestinal Regulation -A Randomized, Double-blind, Placebo-controlled Crossover Study- |
| Date of disclosure of the study information | 2025/07/28 |
| Last modified on | 2025/07/24 16:27:27 |
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Basic information
Public title
A Study on the Effects of the Test Food on Intestinal Regulation -A Randomized, Double-blind, Placebo-controlled Crossover Study-
Acronym
A Study on the Effects of the Test Food on Intestinal Regulation
Scientific Title
A Study on the Effects of the Test Food on Intestinal Regulation -A Randomized, Double-blind, Placebo-controlled Crossover Study-
Scientific Title:Acronym
A Study on the Effects of the Test Food on Intestinal Regulation -A Randomized, Double-blind, Placebo-controlled Crossover Study-
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of test food on bowel movements and intestinal environment for four weeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Defecation frequency
Key secondary outcomes
1) Defecation status
2) The Constipation Assessment Scale Middle Term version (CAS-MT)
3) Gut microbiota
4) Fecal organic acids content
5) Fecal putrefactive products content
6) Fecal ammonia content
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
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Consumption of the test food (1 pack a day, 4 weeks) -> Washout period (4 weeks) -> Consumption of the placebo food (1 pack a day, 4 weeks)
Interventions/Control_2
Consumption of the placebo food (1 pack a day, 4 weeks) -> Washout period (4 weeks) -> Consumption of the test food (1 pack a day, 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) Healthy subjects aged of 20-64 years
2) Subjects who defecate 3-5 times a week at the point of screening test
3) Subjects who have received sufficient explanation of the purpose and content of the study, have the ability to consent, voluntarily applied to participate on good understanding, and have agreed to participate in the study in writing
Key exclusion criteria
1) Subjects who have a history, current history or undergoing medical treatment of serious kidney disease, heart disease, respiratory disease, endocrine disease or diabetes
2) Subjects who have a chronic disease and regularly use medications
3) Subjects who diagnosed with chronic constipation
4) Subjects who have a digestive disease that affects digestion and absorption or defection, or a history of surgery (excluding appendicitis)
5) Subjects who have a history or current medical history of drug dependence or alcoholism
6) Subjects who plan to take medicines that affect the intestinal environment from the time of research application until the end of the study period
7) Subjects who are taking antibiotics or antibacterial agents, or who have taken them from the time of research application
8) Subjects who have consumed health foods or supplements that are known to improve constipation or affect the intestinal environment, 3 times a week or more at the time of the screening test
9) Subjects who have reported that they are allergic to the ingredient in test foods
10) Subjects who have a habit of drinking excessively
11) Subjects who have a habit of smoking excessively
12) Subjects who are pregnant, planning to become pregnant during this study or lactating
13) Subjects who are planning to participate and/or had participated in other clinical studies within the last one month of informed consent
14) Subjects who plan to change their existing lifestyle, eating habits or living environment during the study period
15) Subjects who had one or less meals per day at least once a week during the month prior to application for the study
16) Subjects who have donated more than 200 mL of blood and/or component blood within one month or more than 400 mL within three months of consent in this study
17) Subjects who are restricting carbohydrates or dieting
18) Subjects who are judged as ineligible to participate in this study by the principal investigator
Target sample size
50
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 | Masanori |
| Middle name | |
| Last name | Numazu |
Organization
KSO Corporation
Division name
Clinical Trial Management department
Zip code
105-0023
Address
Shibaura Omodaka Building 7F, 1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
eigyou27@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
Morishita Jintan 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
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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 28 | 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 | 30 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 05 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 29 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 13 | 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 | 24 | Day |
Last modified on
| 2025 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066943
