UMIN-CTR Clinical Trial

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
Email	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
Email	rinoue@fhw.oka-pu.ac.jp

Sponsor
Institute	Okayama Prefectural University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045185