UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047062 |
|---|---|
| Receipt number | R000053689 |
| Scientific Title | Prototype implementation test at Pharmalize Holding for social implementation of lunch box for improving Minor Health Complaints |
| Date of disclosure of the study information | 2023/03/31 |
| Last modified on | 2024/09/01 10:29:32 |
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Basic information
Public title
Prototype implementation test at Pharmalize Holding for social implementation of lunch box for improving Minor Health Complaints
Acronym
Beneficial Effect of the Functional Lunch Boxes on Improving Minor Health Complaints
Scientific Title
Prototype implementation test at Pharmalize Holding for social implementation of lunch box for improving Minor Health Complaints
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 double-blind, placebo-controlled, parallel group comparison study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Minor Health Complains after 8 weeks of ingestion. (Comprehensive valuation by the brief job stress questionnaire and subjective accomplishment
Key secondary outcomes
Body composition, sleep quality, meal records and meal satisfaction surveys, thoughts on the test
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
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
Placebo Lunch Boxes for 8 weeks, including 180g of rice, 300g of non-functional side dish and 2g of tea.
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 belong to Pharmarise Holding company group who are worried about metabolic syndrome.
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 schizophreni a 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. Heavy smokers, alcohol addicts or subjects with disordered lifestyle.
10. 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.
11. Pregnant or lactating women or women who expect to be pregnant during this study.
12. Subjects who currently participate in other clinical trials or participated within the last 4 wks prior to the current study.
13. Any other medical and/or health reasons unfavorable to participation in the current study, as judged by the principal investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hajime |
| Middle name | |
| Last name | SHIMAZAKI |
Organization
Medical Front Corporation
Division name
President
Zip code
164-0011
Address
1-38-1 Chuo, Nakano-ku, Tokyo, Japan
TEL
03-6661-0892
shimazaki_h@mfc-net.com
Public contact
Name of contact person
| 1st name | Hajime |
| Middle name | |
| Last name | SHIMAZAKI |
Organization
Medical Front Corporation
Division name
President
Zip code
164-0011
Address
1-38-1 Chuo, Nakano-ku, Tokyo, Japan
TEL
03-6661-0892
Homepage URL
shimazaki_h@mfc-net.com
Sponsor or person
Institute
Medical Front 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
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
30
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
| 2022 | Year | 01 | Month | 06 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 06 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 06 | 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 | 03 | 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=R000053689
