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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000027884
Receipt No. R000031928
Scientific Title Intervention study on obesity and mental health improvement through nutritional education focusing on gut microbiota composition
Date of disclosure of the study information 2017/06/23
Last modified on 2019/12/26

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Basic information
Public title Intervention study on obesity and mental health improvement through nutritional education focusing on gut microbiota composition
Acronym Intervention study on obesity and mental health improvement through nutritional education focusing on gut microbiota composition
Scientific Title Intervention study on obesity and mental health improvement through nutritional education focusing on gut microbiota composition
Scientific Title:Acronym Intervention study on obesity and mental health improvement through nutritional education focusing on gut microbiota composition
Region
Japan

Condition
Condition Obesity
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the improvement effect of obesity and mental health by nutritional education focusing on gut microbiota composition.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Body weight change after about 2-3 months from the start of intervention.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Intervention group: Nutritional education->Control
Interventions/Control_2 Delayed intervention group: Control->Nutritional education
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 Female
Key inclusion criteria Obese individual
Key exclusion criteria Those who are undergoing medical treatment and whose dietary regulation is strictly controlled by medical staffs.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mayu Uemura
Organization Nagoya University Graduate School of Medicine
Division name Public Health and Health Systems
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya
TEL 0527442128
Email mayu-u@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mayu Uemura
Organization Nagoya University Graduate School of Medicine
Division name Public Health and Health Systems
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya
TEL 0527442128
Homepage URL
Email mayu-u@med.nagoya-u.ac.jp

Sponsor
Institute Department of Public Health and Health Systems
Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology-Japan
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 06 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
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
2017 Year 12 Month 31 Day
Date of IRB
2017 Year 07 Month 28 Day
Anticipated trial start date
2018 Year 01 Month 31 Day
Last follow-up date
2019 Year 01 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
2017 Year 06 Month 23 Day
Last modified on
2019 Year 12 Month 26 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031928

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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