UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of a program of dietary instructions with a national registered dietitian
Title of the study (Brief title)	Examination of a program of dietary instructions with a national registered dietitian
Region	Japan

Condition
Condition	Healthy people
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To study the relationship between dietary instructions and health challenges
Basic objectives2	Others
Basic objectives -Others	To study the relationship between dietary instructions and health challenges
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the relationship between content of meals and health conditions
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Personalized dietary instruction by a national registered dietitian in 3months
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	30 years-old <=
Age-upper limit	60 years-old >=
Gender	Male
Key inclusion criteria	-Healthy adults who have and would like to work on healthy challenges -Males aged 30 to 60 years on the day of signing the informed consent -Person who can operate a smartphone application LINE -Subjects who can agree to participate in the study and provide written informed consent.
Key exclusion criteria	-Person who will be on an extended business trip in the examination period -Person who takes medicine and supplement which may be related to fatness. -Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size	10

Research contact person
Name of lead principal investigator	Hideaki Sakate
Organization	ROHTO Pharmaceutical Co., Ltd.
Division name	General affairs and human resources division
Address	Grand Front Osaka B29F,3-1 Ofukacho, Kita-ku, Osaka 530-0011
TEL	06-6758-1235
Email	sakate@rohto.co.jp

Public contact
Name of contact person	Hideaki Sakate
Organization	ROHTO Pharmaceutical Co., Ltd.
Division name	General Affairs and Human Resources Division
Address	Grand Front Osaka B29F,3-1 Ofukacho, Kita-ku, Osaka 530-0011
TEL	06-6758-1235
Homepage URL
Email	sakate@rohto.co.jp

Sponsor
Institute	ROHTO Pharmaceutical Co., Ltd.
Institute
Department

Funding Source
Organization	ROHTO Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization	Self funding
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	2018 Year 03 Month 20 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 03 Month 06 Day
Anticipated trial start date	2018 Year 03 Month 20 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	2018 Year 03 Month 15 Day
Last modified on	2018 Year 03 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036248