UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061341 |
|---|---|
| Receipt number | R000070087 |
| Scientific Title | An Investigation on the Impact of a Nutritionally Balanced Diet on Presenteeism |
| Date of disclosure of the study information | 2026/04/22 |
| Last modified on | 2026/04/21 17:30:35 |
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Basic information
Public title
An Investigation on the Impact of a Nutritionally Balanced Diet on Presenteeism
Acronym
An Investigation on the Impact of a Nutritionally Balanced Diet on Presenteeism
Scientific Title
An Investigation on the Impact of a Nutritionally Balanced Diet on Presenteeism
Scientific Title:Acronym
An Investigation on the Impact of a Nutritionally Balanced Diet on Presenteeism
Region
| Japan |
Condition
Condition
worker
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the impact of consuming nutritionally balanced meals* on presenteeism among workers.
*Refers to meals based on the nutritional design standards (T-001) of the Japan Association for Optimal Nutrition
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes to the Japanese Version of WLQ
Key secondary outcomes
A. Predictive model for improvements in WLQ
B. Changes in the following items before and after intervention
1. Patient Health Questionnaire-9 (PHQ-9)
2. Revised State-Trait Anxiety Inventory (STAI)
3. Athens Insomnia Scale
4. Heart rate variability data
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
One nutritionally balanced meal a day at lunchtime
Interventions/Control_2
No nutritionally balanced meal a day
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Individuals aged 18 or older
2. Employees of Nissin Foods Co., Ltd. and Nissin Foods Holdings Co., Ltd.
3. Individuals who fully understand the purpose of this test and have agreed to participate in it
Key exclusion criteria
1. Individuals deemed unsuitable for this trial by the principal investigator or co-investigators
2. Individuals who plan to consume nutritionally balanced meals outside of the meal intervention period between the time consent is obtained and the conclusion of the study
3. Individuals with dementia or mental illness who are unable to understand the significance of this study
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Yoshinori |
| Middle name | |
| Last name | Katsumata |
Organization
keio University
Division name
School of Medicine, Institute for Integrated Sports Medicine
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582 Japan
TEL
09091066192
goodcentury21@keio.jp
Public contact
Name of contact person
| 1st name | YOSHINORI |
| Middle name | |
| Last name | KATSUMATA |
Organization
Keio University
Division name
School of Medicine, Institute for Integrated Sports Medicine
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582 Japan
TEL
09091066192
Homepage URL
goodcentury21@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Yoshinori Katsumata
Funding Source
Organization
Doctors Man Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582 Japan
Tel
0333531211
goodcentury21@keio.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Not required for this country
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 22 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 04 | Month | 21 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 21 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 06 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 04 | Month | 21 | Day |
Last modified on
| 2026 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070087
