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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000038349
Receipt No. R000043704
Scientific Title A study on the effects of different eating habits on intestinal flora.
Date of disclosure of the study information 2019/10/23
Last modified on 2020/01/24

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Basic information
Public title A study on the effects of different eating habits on intestinal flora.
Acronym A study on the effects of different eating habits on intestinal flora.
Scientific Title A study on the effects of different eating habits on intestinal flora.
Scientific Title:Acronym A study on the effects of different eating habits on intestinal flora.
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Two groups of subjects living in an urban area and a rural area (Okishima-Cho, Omihachiman-Shi, Shiga) participated in this study. Our goals are to observe the effects of their different eating habits on their health condition and intestinal flora and compare the differences between two groups.
Basic objectives2 Others
Basic objectives -Others Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood and stool tests
Key secondary outcomes

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
40 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria 1.40 to 89 years old.
2.Regardless of sex.
3.Those who live in Okishima-Cho, Omihachiman-Shi, Shiga and who have tasted funazushi, the extremely fermented crucian carp.
4.Those who understand the main purpose of the study and who can provide their informed consent.
Key exclusion criteria 1.Those who received gastrointestinal surgery (except appendectomy).
2.Those who have a current or a past medical history of severe disease.
3.Those who received Helicobacter pylori eradication treatment during the last 6 months.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Hirokuni
Middle name
Last name Kayama
Organization imeQ RD inc.
Division name Sales department
Zip code 169-0051
Address 2-14-6, Nishi-Waseda, Shinjyuku, Tokyo, Japan
TEL 03-6205-6222
Email h-kayama@imeqrd.co.jp

Public contact
Name of contact person
1st name Naomi
Middle name
Last name Yuzawa
Organization imeQ RD inc.
Division name Sales department
Zip code 169-0051
Address 2-14-6, Nishi-Waseda, Shinjyuku, Tokyo, Japan
TEL 03-6205-6222
Homepage URL
Email n-yuzawa@imeqrd.co.jp

Sponsor
Institute integrate co., ltd.
imeQ RD inc.
Institute
Department

Funding Source
Organization Nippon Suisan Kaisha,Ltd.
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Suda Clinic institutional review board
Address 2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel 03-6205-6222
Email suda-clinic_irb@imeq.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
2019 Year 10 Month 23 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 12
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
2019 Year 09 Month 11 Day
Date of IRB
2019 Year 09 Month 24 Day
Anticipated trial start date
2019 Year 10 Month 24 Day
Last follow-up date
2019 Year 12 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The subjects living in a rural area (Okishima-Cho, Omihachiman-Shi, Shiga) participated in this study.
We observed their health condition and intestinal flora.

Management information
Registered date
2019 Year 10 Month 21 Day
Last modified on
2020 Year 01 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043704

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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