UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048871 |
|---|---|
| Receipt number | R000055690 |
| Scientific Title | Examination of the effect of diets on the gut microbial metatranscriptome |
| Date of disclosure of the study information | 2022/09/08 |
| Last modified on | 2023/09/07 14:59:58 |
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Basic information
Public title
Examination of the effect of diets on the gut microbial metatranscriptome
Acronym
Examination of the effect of diets on the gut microbial metatranscriptome
Scientific Title
Examination of the effect of diets on the gut microbial metatranscriptome
Scientific Title:Acronym
Examination of the effect of diets on the gut microbial metatranscriptome
Region
| Japan |
Condition
Condition
Healthy Volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of the effect of diets on the gut microbial metatranscriptome
Basic objectives2
Others
Basic objectives -Others
Exploratory study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
-variations in gut microbial metatranscriptome
-variations in blood metabolome
Key secondary outcomes
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
Dietary intervention
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Subjects who voluntarily give written informed consent
2)Healthy subjects who are aged 20-59
3)Subjects who can participate in dietary interventions, fecal samplings, blood samplings and urine samplings as scheduled
Key exclusion criteria
1) Subjects whose blood test results are judged to be ineligible for this study by lead principal investigator
2) Subjects who have constipation or diarrhea for more than 3 days in one week
3) Subjects who had a history of GI disorders and cardiovascular disorders, or who had a history of treatments by doctors for more than 1 months
4) Subjects with allergies
5) Subjects who used antibiotics within last one month prior to fecal samplings
6) Subjects who donated more than 400 mL of blood within last 12 months (male) or within last 16 months (female), who donated more than 200 mL of blood within last one month, or who donated blood components within last two weeks prior to this study
7) Subjects who underwent GI tract surgery in the past half year
8) Subjects who are participating in other clinical studies or who are planning to participate in other clinical studies
9) Subjects who work night shifts
10) Subjects who are facing big changes in situation (such as getting married or divorced, a change in residence, or a job transfer)
11) Subjects who are during lactation or pregnancy, who wish to get pregnant, or who cannot turn in fecal samples because of menstruation
12) Subjects who are judged to be ineligible for this study by lead principal investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yasutaka |
| Middle name | |
| Last name | Ikeda |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Otsu Nutraceuticals Research Institute
Zip code
520-0002
Address
3-31-13 Saigawa, Otsu, Shiga, 520-0002
TEL
+81-77-521-8835
Ikeda.Yasutaka@otsuka.jp
Public contact
Name of contact person
| 1st name | Aina |
| Middle name | |
| Last name | Katoh |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Otsu Nutraceuticals Research Institute
Zip code
520-0002
Address
3-31-13 Saigawa, Otsu, Shiga, 520-0002
TEL
0775218835
Homepage URL
Kato.Aina@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Physical Education and Medicine Research Foundation
Mimaki Onsen (Spa) Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Otsuka Pharmaceutical Co., Ltd.
Address
Shinagawa Grand Central Tower, 2-16-4 Konan, Minato-ku, Tokyo 108-8242, Japan
Tel
03-6717-1499
shimizu_se@otsuka.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
| 2022 | Year | 09 | Month | 08 | 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
| 2022 | Year | 09 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 09 | Month | 08 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 07 | Day |
Last modified on
| 2023 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055690
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
