UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057137 |
|---|---|
| Receipt number | R000065311 |
| Scientific Title | Study on the intestinal regulating effects of the food ingredient ingestion. -A randomized, placebo-controlled, double-blind, parallel-group comparison study- |
| Date of disclosure of the study information | 2025/03/01 |
| Last modified on | 2026/03/19 09:30:20 |
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Basic information
Public title
Study on the intestinal regulating effects of the food ingredient ingestion.
-A randomized, placebo-controlled, double-blind, parallel-group comparison study-
Acronym
Study on the intestinal regulating effects of the food ingredient ingestion.
Scientific Title
Study on the intestinal regulating effects of the food ingredient ingestion.
-A randomized, placebo-controlled, double-blind, parallel-group comparison study-
Scientific Title:Acronym
Study on the intestinal regulating effects of the food ingredient ingestion.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the intestinal regulating effect of the food ingredient ingestion.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of defecation
Key secondary outcomes
Defecation status
Intestinal environment
Indicators related to glucose metabolism and liver function
Questionnaire on physical condition and mood
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
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Take the test food for 4 consecutive weeks.
Interventions/Control_2
Take the control food for 4 consecutive 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 males and females who are aged 20-64 years at the time of obtaining consent
2)Subjects who defecate 3-5 times a week at the point of screening test
3)Subjects who have received a sufficient explanation of the purpose and content of the study, have the consent ability and good understandings, and have agreed voluntarily in writing to participate in the study
Key exclusion criteria
Subjects (who)
1)regularly take bowel medicines and laxatives
2)regularly take health foods that are known to improve constipation at the time of screening test
3)take drugs that affect digestion and absorption for 2 weeks prior to the screening test
4)cannot stop taking food for specified health uses, with functional claims, with nutrient function claims and supplements during the study period
5)with serious diseases such as malignant tumours,or with a serious history of these diseases
6)with allergies to food ingredients in the test food
7)habitually take excessive amounts of alcohol (maximum daily amount: equivalent to 20.1 g pure alcohol equivalent or more and at least 4 days a week) or who are unable to abstain from alcohol during the designated period
8)with a smoking habit
9)suffering from a disease requiring urgent treatment or with serious complications
10)with a history of digestive disorders or surgery affecting digestion, absorption or defecation (excluding adenoidectomy, appendicitis, etc.)
11)are pregnant, wish to become pregnant during the study period, or breast-feeding
12)with a history or current history of drug or alcohol dependence
13)work shifts or late nights
14)with an extremely irregular diet
15)plan to go abroad during the study period
16)plan to transfer or move during the study period
17)can only go to the toilet at set times during the study period due to work or other reasons
18)with a weight fluctuation of more than plus or minus 5 kg within 2 months prior to the start of the screening test
19)have had a blood collection or component blood donation of more than 200 mL within 1 month of the screening test or 400 mL within 3 months prior to the screening test
20)have participated or wish to participate in trials involving the ingestion of other foods or the use of drugs, or the application of cosmetics and drugs, within 3 months before the date of obtaining consent
21)are judged unsuitable as a subject 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 | Eiji |
| Middle name | |
| Last name | Yoshikawa |
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
Yaizu Suisankagaku Industry 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 | 03 | 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
Completed
Date of protocol fixation
| 2025 | Year | 02 | Month | 06 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 06 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 02 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 30 | 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 | 02 | Month | 26 | Day |
Last modified on
| 2026 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065311
