UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052376 |
|---|---|
| Receipt number | R000059771 |
| Scientific Title | Exploratory study on the intestinal regulating effects of test food intake using responder determination |
| Date of disclosure of the study information | 2023/10/02 |
| Last modified on | 2024/07/29 19:33:44 |
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Basic information
Public title
Exploratory study on the intestinal regulating effects of test food intake using responder determination
Acronym
Exploratory study on the intestinal regulating effects of test food intake using responder determination
Scientific Title
Exploratory study on the intestinal regulating effects of test food intake using responder determination
Scientific Title:Acronym
Exploratory study on the intestinal regulating effects of test food intake using responder determination
Region
| Japan |
Condition
Condition
Healthy male/female adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of test food on bowl movements for two weeks.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Defecation frequency
Key secondary outcomes
1. Defecation status
2. Abdominal symptoms at times other than defecation
3. CAS-MT
4. Gut microbiota
5. Gut metabolites
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, 2 weeks) -> Washout period (4 weeks) -> Consumption of the placebo food (1 pack a day, 2 weeks)
Interventions/Control_2
Consumption of the placebo food (1 pack a day, 2 weeks) -> Washout period (4 weeks) -> Consumption of the test food (1 pack a day, 2 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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) At informed consent, male/female subjects aged more than or equal to 40, and less than 65 years old.
(2) Subjects who have a defection frequency for 3 to 5 times in a week
(3) Subjects who can show their understanding of the study procedure and agreement with participating in the study by written informed consent prior to the study.
Key exclusion criteria
(1) Subjects who are taking food for specified health use, foods with functional claims, health foods, or supplements that may affect the intestinal environment and have been unable to discontinue them since the time of obtaining consent.
(2) Subjects who have a plan or who have taken medication within a month before the pre-test start, which would affect the intestinal environment.
(3) Subjects who had undergone appendectomy.
(4) Subjects who have received the surgery which would affect the trial result within half a year before obtaining a consent.
(5) Subjects who take excessive alcohol.
(6) Smoker
(7) Subjects having an irregular life rhythm with irregular shift work or midnight.
(8) Subjects who are now under other clinical tests with some kind of medicine/food, or participated in those within a month before this trial, or will join those after giving informed consent to participate in this trial.
(9) Subjects whose roomer is planning to join this trial.
(10) Subjects who have previous/current medical history of severe cardiac, hepatic, renal or digestive diseases.
(11) Pregnant, possibly pregnant, or lactating women.
(12) Subjects who are allergic to medicines and test foods.
Subjects who donated their blood components, and/or whole blood as below
(13) all subjects: 200 mL within a month
(14) males: 400 mL within the last 3 months
(15) females: 400 mL within the last 4 months to this trial.
Subjects whose collected blood volume within the last 12 months would reach to the following criteria after adding the blood collection in this study;
(16) males: 1,200 mL
(17) females: 800 mL
(18) Others who have been determined ineligible by the principal/sub investigator.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Shinnosuke |
| Middle name | |
| Last name | Murakami |
Organization
Metagen, Inc.
Division name
Headquarters
Zip code
997-0052
Address
246-2 Mizukami, Kakuganji, Tsuruoka, Yamagata, Japan
TEL
+81-235-64-0330
research@metagen.co.jp
Public contact
Name of contact person
| 1st name | Fumiko |
| Middle name | |
| Last name | Nakamura |
Organization
CPCC Company Limited
Division name
Clinical Support Division
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongokucho, Chuo-ku, Tokyo, Japan
TEL
+81-3-6225-9001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
Metagen, Inc.
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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongokucho, Chuo-ku, Tokyo 103-0021, Japan
Tel
+81-3-6225-9005
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
| 2023 | Year | 10 | Month | 02 | 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
| 2023 | Year | 09 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 02 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 02 | Day |
Last modified on
| 2024 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059771
