UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on behavior modification to lifestyle disease risk factor of company cafeteria users when healthy menu are continuously provided for six months.
Title of the study (Brief title)	A clinical trial to study the effect of healthy menu to a mind and body (KR-01)
Region	Japan

Condition
Condition	Healthy volunteer
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of continuously provided the healthy menu on lifestyle disease risk factor.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Stage of behavior modification (0M,3M,6M)
Key secondary outcomes	1) Weight(BMI), Body Fat percentage 2) Blood pressure 3) Dietary survey 4) Profile of mood states 5) Sleep survey 6) Blood test (GLU, HbA1c, AST(GOT), ALT(GPT), gamma-GTP, TC, HDL-C, LDL-C, TG, BUN, Cre, UA, TP, Alb) 7) Urine test (Na, Cre) 8) Usage frequency survey of healthy menu 9) Frequency of bowel movement 10) Satisfaction survey to meals (0M, 3M, 6M)

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Period:6 months Frequency:3 or more times/week Test food:healthy menu lunch
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Age over 20 years and BMI over 23.0 kg/m*m 2) Age over 40 years old and selected based on a diagnostic criterion for a metabolic syndrome
Key exclusion criteria	1) Subjects who receive nutritional guidance 2) Subjects who are planned to participate in other clinical study 3) Subjects who are pregnant or breastfeed 4) Subjects who visit a hospital for treatment or take medicine for treatment
Target sample size	20

Research contact person
Name of lead principal investigator	Kei Yui
Organization	FANCL Corporation
Division name	Research Institute
Address	12-13 Kamishinano, Totuska-ku, Yokohama, kanagawa, Japan
TEL	045-820-3532
Email	ke-yui@fancl.co.jp

Public contact
Name of contact person	Yuri Ishii
Organization	FANCL Corporation
Division name	Research Institute
Address	12-13 Kamishinano, Totuska-ku, Yokohama, kanagawa, Japan
TEL	045-820-3419
Homepage URL
Email	yuishii@fancl.co.jp

Sponsor
Institute	FANCL Corporation
Institute
Department

Funding Source
Organization	FANCL Corporation
Organization
Division
Category of Funding Organization	Profit organization
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	㈱ファンケル（神奈川県）/FANCL Co.

Other administrative information
Date of disclosure of the study information	2018 Year 02 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 12 Month 14 Day
Anticipated trial start date	2018 Year 01 Month 23 Day
Last follow-up date	2018 Year 07 Month 23 Day
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 01 Month 31 Day
Last modified on	2018 Year 08 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035503