UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059779 |
|---|---|
| Receipt number | R000068341 |
| Scientific Title | Research on the long-term consumption of dietary fiber-containing food. |
| Date of disclosure of the study information | 2025/11/25 |
| Last modified on | 2025/11/13 17:15:33 |
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Basic information
Public title
Research on the long-term consumption of dietary fiber-containing food.
Acronym
Research on the long-term consumption of dietary fiber-containing food.
Scientific Title
Research on the long-term consumption of dietary fiber-containing food.
Scientific Title:Acronym
Research on the long-term consumption of dietary fiber-containing food.
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Safety assessment of long-term consumption of dietary fiber-containing food.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Safety assessment of long-term consumption of dietary fiber-containing food.
Key secondary outcomes
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
Continuous intake of test food for 12 weeks
Interventions/Control_2
Continuous intake of placebo for 12 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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Male and female aged 20 to 64
(2) Subjects who have a bowel movement frequency of more than 6 times/week or between 3 and 5 times/week
(3) Subjects who fully understand the purpose and content of this study and voluntarily agree to participate in the study
Key exclusion criteria
(1) Subjects who take health foods related to the test food more than 1 day a week
(2) Subjects who habitually take health foods or pharmaceuticals that are expected to have effects that overlap with the product concept
(3) Subjects with a medical condition that may affect the study
(4) Subjects who are diagnosed by a doctor with constipation or irritable bowel syndrome, currently.
(5) Subjects who have had abnormalities in clinical test values or cardiopulmonary function and are judged to be unsuitable for participation in the study
(6) Subjects who are at risk of developing allergies related to the study
(7) Subjects with a disease requiring regular medication, with a disease currently being treated (excluding dry eyes and tooth decay) or with a history of a serious disease that required medication
(8) Subjects whose pre-intake test results are significantly outside the reference range
(9) Subjects who work in shifts, late-night shifts, or have other irregular lifestyles
(10) Subjects who have participated or plan to participate in other studies within one month of the start of the study or during the study
(11) Females who are pregnant, potentially pregnant (only to wish to become pregnant during the study period), or breastfeeding
(12) Subjects who are judged to be unsuitable for participation in the study based on their responses to the lifestyle questionnaire or pre-intake test results
(13) Subjects who are judged as unsuitable for the study by the investigator for other reason
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Masakazu |
| Middle name | |
| Last name | Kobayashi |
Organization
Kobayashi Pharmaceutical Co., Ltd.
Division name
R&D Headquarters, Healthcare Product Development Department, Manager
Zip code
567-0057
Address
1-30-3 Toyokawa, Ibaraki-shi, Osaka
TEL
080-3452-9955
masa-kobayashi@kobayashi.co.jp
Public contact
Name of contact person
| 1st name | Akane |
| Middle name | |
| Last name | Morimoto |
Organization
EP Mediate Co., Ltd.
Division name
Development Department Trial Planning Section
Zip code
162-0814
Address
Acropolis Tokyo, 6-29 Shin-ogawamachi, Shinjuku, Tokyo
TEL
070-7079-8489
Homepage URL
morimoto.akane003@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd.
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
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguro-ku, Tokyo
Tel
03-6452-2712
epmd_fd-erb@eps.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
メディカルステーションクリニック (Medical station clinic) (東京都)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 25 | 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 | 10 | Month | 23 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 23 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 08 | 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 | 11 | Month | 14 | Day |
Last modified on
| 2025 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068341
