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
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
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
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
