UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Intervention study on mental health and obesity improvement through nutritional education focusing on gut microbiota composition
Title of the study (Brief title)	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	Tetsuya Ohira
Organization	Fukushima Medical University
Division name	Department of Epidemiology, School of Medicine
Address	1 Hikarigaoka, Fukushima City, Fukushima, Japan
TEL	024-547-1343
Email	teoohira@fmu.ac.jp

Public contact
Name of contact person	Mayu Uemura
Organization	Fukushima Medical University
Division name	Department of Epidemiology, School of Medicine
Address	1 Hikarigaoka, Fukushima City, Fukushima, Japan
TEL	024-547-1343
Homepage URL
Email	mayu.u0141@gmail.com

Sponsor
Institute	Department of Epidemiology, Fukushima Medical University School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 11 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033180