UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031088
Receipt number R000035503
Scientific Title Study on behavior modification to lifestyle disease risk factor of company cafeteria users when healthy menu are continuously provided for six months.
Date of disclosure of the study information 2018/02/01
Last modified on 2018/08/09 11:45:00

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Basic information

Public title

Study on behavior modification to lifestyle disease risk factor of company cafeteria users when healthy menu are continuously provided for six months.

Acronym

A clinical trial to study the effect of healthy menu to a mind and body (KR-01)

Scientific Title

Study on behavior modification to lifestyle disease risk factor of company cafeteria users when healthy menu are continuously provided for six months.

Scientific Title:Acronym

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

1st name
Middle name
Last name Kei Yui

Organization

FANCL Corporation

Division name

Research Institute

Zip code


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

1st name
Middle name
Last name Yuri Ishii

Organization

FANCL Corporation

Division name

Research Institute

Zip code


Address

12-13 Kamishinano, Totuska-ku, Yokohama, kanagawa, Japan

TEL

045-820-3419

Homepage URL


Email

yuishii@fancl.co.jp


Sponsor or person

Institute

FANCL Corporation

Institute

Department

Personal name



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)



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

㈱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


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

2017 Year 12 Month 14 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035503


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name