UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028996 |
|---|---|
| Receipt number | R000033180 |
| Scientific Title | Intervention study on mental health and obesity improvement through nutritional education focusing on gut microbiota composition |
| Date of disclosure of the study information | 2017/09/04 |
| Last modified on | 2017/09/04 22:41:45 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Intervention study on mental health and obesity improvement through nutritional education focusing on gut microbiota composition
Acronym
Intervention study on mental health and obesity improvement through nutritional education focusing on gut microbiota composition
Scientific Title
Intervention study on mental health and obesity improvement through nutritional education focusing on gut microbiota composition
Scientific Title:Acronym
Intervention study on mental health and obesity 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 among obese individuals in Fukushima prefecture.
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
Dynamic allocation
Institution consideration
Blocking
Concealment
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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and 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 | Tetsuya Ohira |
Organization
Fukushima Medical University
Division name
Department of Epidemiology, School of Medicine
Zip code
Address
1 Hikarigaoka, Fukushima City, Fukushima, Japan
TEL
024-547-1343
teoohira@fmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mayu Uemura |
Organization
Fukushima Medical University
Division name
Department of Epidemiology, School of Medicine
Zip code
Address
1 Hikarigaoka, Fukushima City, Fukushima, Japan
TEL
024-547-1343
Homepage URL
mayu.u0141@gmail.com
Sponsor or person
Institute
Department of Epidemiology, Fukushima Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The SKYLARK Food Science Institute
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 09 | Month | 04 | 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
| 2016 | Year | 11 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 04 | Day |
Last modified on
| 2017 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033180
