UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053235 |
|---|---|
| Receipt number | R000060748 |
| Scientific Title | Evaluation of the effect of test food intake on the gut environment |
| Date of disclosure of the study information | 2024/12/26 |
| Last modified on | 2024/07/29 19:41:44 |
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Basic information
Public title
Evaluation of the effect of test food intake on the gut environment
Acronym
Evaluation of the effect of test food intake on the gut environment
Scientific Title
Evaluation of the effect of test food intake on the gut environment
Scientific Title:Acronym
Evaluation of the effect of test food intake on the gut environment
Region
| Japan |
Condition
Condition
Healthy male/female adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of test food on gut environment
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
VAS (fatigue)
Key secondary outcomes
- Intestinal barrier
- Gut microbiota
- Gut metabolites
- Defecation status
- POMS2
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Consumption of the test food 1 (1 pack a day, 4 weeks) -> Consumption of the test food 2 (1 pack a day, 4 weeks)
Interventions/Control_2
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) At informed consent, male/female subjects aged more than or equal to 20, and less than 65 years old.
(2) 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 regularly use foods that explicitly contain tamarind seed gum as a food additive and have been unable to discontinue them since the time of obtaining consent.
(2) Subjects who are taking food for specified health use, foods with functional claims, or health foods (including supplements) that may affect the study at least three times a week and are unable to maintain the amount and frequency of intake during the study period.
(3) Subjects who are taking medicines (antibiotics, bowel regulators, antidiarrheals, laxatives) at least once a week that could potentially affect the study and whose medication cannot be restricted during the study period (no medication, but eye and nose drops are allowed)
(4) 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.
(5) Subjects who have previous/current medical history of illnesses related to immunity, such as autoimmune diseases, or gastrointestinal diseases.
(6) Pregnant, possibly pregnant, or lactating women.
(7) Subjects who are allergic to medicines and test foods (tamarind seed gum).
(8) Others who have been determined ineligible by the principal/sub investigator.
Target sample size
12
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 | Yumewo |
| Middle name | |
| Last name | Suzuki |
Organization
MP Gokyo Food & Chemical Co., Ltd.
Division name
Planning & Coordination / Research, Development & Technology
Zip code
530-0001
Address
2-5-25 Umeda, Kita-ku, Osaka
TEL
06-7177-6866
Homepage URL
yumeo.suzuki@mpgfc.co.jp
Sponsor or person
Institute
Metagen, Inc.
Institute
Department
Personal name
Funding Source
Organization
MP Gokyo Food & Chemical 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
| 2024 | Year | 12 | Month | 26 | 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 | 12 | Month | 18 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 26 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 29 | 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 | 12 | Month | 26 | 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=R000060748
