UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047054 |
|---|---|
| Receipt number | R000053679 |
| Scientific Title | Effect of Daily Ingestion of the Functional Lunch boxes on Improving Minor Health Complaints: A Proto-type Implementation Study in Kameyama, Mie. |
| Date of disclosure of the study information | 2023/03/31 |
| Last modified on | 2024/09/01 10:27:05 |
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Basic information
Public title
Effect of Daily Ingestion of the Functional Lunch boxes on Improving Minor Health Complaints: A Proto-type Implementation Study in Kameyama, Mie.
Acronym
Beneficial Effect of the Functional Lunch Boxes on Improving Minor Health Complaints
Scientific Title
Effect of Daily Ingestion of the Functional Lunch boxes on Improving Minor Health Complaints: A Proto-type Implementation Study in Kameyama, Mie.
Scientific Title:Acronym
Beneficial Effect of the Functional Lunch Boxes on Improving Minor Health Complaints
Region
| Japan |
Condition
Condition
Japanese healthy adult workers
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prove improving minor health complaints and safety associated with 8 weeks daily ingestion of functional lunch boxes, in a single-group study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comprehensive valuation by the brief job stress questionnaire (Section B) and subjective accomplishment after 8 weeks of ingestion
Key secondary outcomes
Body composition, sleep quality, sleep heart rate and sleep record, meal records and meal satisfaction surveys, thoughts on the test
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Functional Lunch Boxes for 8 weeks, including 180g of sticky barley-rice, 300g of functional side dish and 2g of functional tea.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Healthy workers who live or work in Kameyama city and are worried about metabolic syndrome, or Healthy workers elder than 60.
2. Subjects between the ages of 30 and 70 who are health-conscious and have Japanese nationality.
3. Subjects who have minor health complaints at before the test.
4. Subjects who have the privately owned smartphones and can use them.
5. Subjects who agree to participate in this study with a written informed consent.
Key exclusion criteria
1. Subjects who are under physicians advice, treatment, and/or medication for schizophrenia, depression, mania, neurological disorders, and/or sleep disorders.
2. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities.
3. Subjects with major surgical history relevant to the digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc.
4. Subjects with implantable electronic medical devices.
5. Subjects who are under nutritional advice by a physician.
6. Pre- or post-menopausal women complaining of obvious physical changes.
7. Subjects who cannot continue to consume the test foods due to allergic reactions to drugs or foods (especially wheat and grass), and those who regularly use health foods including drugs and supplements that affect stress and sleep.
8. Subjects who regularly use medicines (sleeping pills, psychotropic drugs, etc.) or health foods/supplements (glycine, gamma-aminobutyric acid, L-serine, L-theanine, L-ornithine, reduced coenzyme Q10, etc.) that affect stress and sleep.
9. Subjects who regularly take medicine, functional foods, and/or supplements which would affect sleep and/or stress.
10. Heavy smokers, alcohol addicts or subjects with disordered lifestyle.
11. Subjects who donated either 400 ml whole blood within 16 wks (women), 12 wks (men), 200 ml whole blood within 4 wks, or blood components within 2 wks, prior to the current study.
12. Pregnant or lactating women or women who expect to be pregnant during this study.
13. Subjects who currently participate in other clinical trials or participated within the last 4 wks prior to the current study.
14. Any other medical and/or health reasons unfavorable to participation in the current study, as judged by the principal investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | MATSUMOTO |
Organization
NxtQOL connect corporation
Division name
President
Zip code
653-0832
Address
3-1-8, Mifunedori, Nagata, Kobe, Hyogo, Japan
TEL
090-6065-7948
taka.m@nxtqol.co.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | MATSUMOTO |
Organization
NxtQOL connect corporation
Division name
President
Zip code
653-0832
Address
3-1-8, Mifunedori, Nagata, Kobe, Hyogo, Japan
TEL
090-6065-7948
Homepage URL
taka.m@nxtqol.co.jp
Sponsor or person
Institute
NxtQOL connect corporation
Institute
Department
Personal name
Funding Source
Organization
Cabinet Office, Government of Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Agriculture and Food Research Organization
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Implementation Experiment Ethics Committee for SIP2 Naro Style PLUS Lunch Boxes 2021
Address
3-1-8, Mifunedori, Nagata, Kobe, Hyogo, 653-0832, Japan
Tel
090-6065-7948
taka.m@nxtqol.co.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
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
https://doi.org/10.3390/nu16101410
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.3390/nu16101410
Number of participants that the trial has enrolled
97
Results
Subjective accomplishment and daytime sleepness, which change daily, are strongly influenced by the meal eaten before work, and that taking the 17 nutrients may help prevent presenteeism and improve labor productivity. It also indicates that it may be useful to provide lunch at companies that engage in health management.
Results date posted
| 2024 | Year | 09 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We recruited healthy Japanese volunteers (aged 30-79 years) who worked in Kameyama city. We enrolled 56 younger volunteers (aged 30-59 years) who worried about metabolic syndrome and 44 older volunteers (aged 60-79).
Participant flow
First, 100 participants were enrolled. The younger group consisted of participants under 60 years old, while the older group consisted of participants 60 years old and older. Excluding those who voluntarily withdrew, there were 49 males and 48 females. The participants whose questionnaires were complete and who had at least one workday during the survey period numbered 26 males and 28 females in the younger group and 22 males and 19 females in the older group. The gender composition was 1:1 for male-to-female participants.
Adverse events
non
Outcome measures
The BJSQ job stress metrics,
Subjective accomplishmet score on workdays,
Daytime sleepness score on workdays
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 06 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 07 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2024 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 03 | Month | 01 | Day |
Last modified on
| 2024 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053679
