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

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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

Email

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


Email

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


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 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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name