UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043011 |
|---|---|
| Receipt number | R000045185 |
| Scientific Title | Analyze of Gut Microbiota in Well-nourished Adult with Traditional-Carbohydrate based Food and Low Protein Intake and Modern-Carbohydrate based Food and Adequate Protein Intake in Lowland Mimika Regency, Papua |
| Date of disclosure of the study information | 2021/01/15 |
| Last modified on | 2021/01/15 13:53:55 |
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Basic information
Public title
Analyze of Gut Microbiota in Well-nourished Adult with Traditional-Carbohydrate based Food and Low Protein Intake and Modern-Carbohydrate based Food and Adequate Protein Intake in Lowland Mimika Regency, Papua
Acronym
Analyze of Gut Microbiota in Well-nourished Adult with Traditional-Carbohydrate based Food and Low Protein Intake and Modern-Carbohydrate based Food and Adequate Protein Intake in Lowland Mimika Regency, Papua
Scientific Title
Analyze of Gut Microbiota in Well-nourished Adult with Traditional-Carbohydrate based Food and Low Protein Intake and Modern-Carbohydrate based Food and Adequate Protein Intake in Lowland Mimika Regency, Papua
Scientific Title:Acronym
Analyze of Gut Microbiota in Well-nourished Adult with Traditional-Carbohydrate based Food and Low Protein Intake and Modern-Carbohydrate based Food and Adequate Protein Intake in Lowland Mimika Regency, Papua
Region
| Japan | Asia(except Japan) |
Condition
Condition
Good nutritional status of adult with no infectious disease and using any kind of treatment
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To analyze gut microbiota among well-nourished adult who consumed traditional carbohydrate based food with low protein intake and modern carbohydrate based food with adequate protein intake in lowland Mimika, Papua
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gut microbiota level
Key secondary outcomes
Albumin level
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
good nutritional status, eating rice and eating sago
Key exclusion criteria
taken antibiotics, laxatives, medical history of clinically significant disease, gastrointestinal disorder
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Irie |
Organization
Okayama Prefectural University
Division name
Department of Nutrition Sciences
Zip code
719-1197
Address
111 Kuboki, Soja-city, Okayama
TEL
+81-866-94-2111
yirie@fhw.oka-pu.ac.jp
Public contact
Name of contact person
| 1st name | Rikako |
| Middle name | |
| Last name | Inoue |
Organization
Okayama Prefectural University
Division name
Department of Nutrition Sciences
Zip code
719-1197
Address
111 Kuboki, Soja-city, Okayama
TEL
+81-866-94-2111
Homepage URL
rinoue@fhw.oka-pu.ac.jp
Sponsor or person
Institute
Okayama Prefectural University
Institute
Department
Personal name
Funding Source
Organization
Okayama Prefectural University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama Prefectural University
Address
111 Kuboki, Soja-shi, Okayama
Tel
+81-866-94-2111
rinoue@fhw.oka-pu.ac.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
| 2021 | Year | 01 | Month | 15 | 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
50
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 05 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Investigate eating habits and physique with a self-administered questionnaire. Blood is collected and a blood biochemical test is performed.Collect feces and analyze microbiota.
Management information
Registered date
| 2021 | Year | 01 | Month | 15 | Day |
Last modified on
| 2021 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045185
