UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029950 |
|---|---|
| Receipt number | R000034214 |
| Scientific Title | A study for the effects of ingestion of food constituents derived from microorganism on health and work performance of office workers. |
| Date of disclosure of the study information | 2017/11/13 |
| Last modified on | 2019/05/19 21:35:28 |
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Basic information
Public title
A study for the effects of ingestion of food constituents derived from microorganism on health and work performance of office workers.
Acronym
A study for the effects of food constituents derived from microorganism on health and work performance.
Scientific Title
A study for the effects of ingestion of food constituents derived from microorganism on health and work performance of office workers.
Scientific Title:Acronym
A study for the effects of food constituents derived from microorganism on health and work performance.
Region
| Japan |
Condition
Condition
None (Healthy adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of ingestion food constituents derived from microorganism on health and work performance of office workers during winter.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Health and work performance questionnaire
Key secondary outcomes
Mood, physical condition and skin condition questionnaire
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
Ingestion of food constituents derived from microorganism
Interventions/Control_2
Non-ingestion of food constituents derived from microorganism
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Males and females aged from 20 to less than 65 years old.
(2)Individuals who work inside the office.
(3)Individuals who give the informed consents in writing, after receiving enough explanation of the purpose and details of the study, understanding the study well, and deciding to attend the study with their own will.
Key exclusion criteria
(1)Individuals who have or had a serious disease (e.g., diabetes, liver disease, kidney disease, and/or heart disease), thyroid gland disease, adrenal gland disease, and/or metabolic disorder.
(2)Individuals who have chronic diseases and use medicines continuously.
(3)Individuals who declare the allergy symptoms against test food.
(4)Individuals who have tendency to get diarrhea by eating test food.
(5)Individuals who are participating or willing to participate in other clinical trials of food, pharmaceutical or cosmetic products.
(6)Individuals who are pregnant, planning to be pregnant in test period or breastfeeding.
(7)Individuals who are judged as unsuitable for the study based on the results of pre-questionnaire.
(8)Individuals who are judged unsuitable for this study by the investigator for other reasons.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Ryohei |
| Middle name | |
| Last name | Shiraoka |
Organization
Medical fitness laboratory
Division name
None
Zip code
1060032
Address
Sumitomo Fudosan Roppongi Building, 7-18-18, Roppongi, Minato, Tokyo, Japan
TEL
03-6671-9103
mfl-info@medicalfitness.co.jp
Public contact
Name of contact person
| 1st name | Mihoko |
| Middle name | |
| Last name | Takuma |
Organization
Yahoo Japan Corporation
Division name
Good conditioning division
Zip code
1020094
Address
Kioi Tower, Tokyo Garden Terrace Kioicho, 1-3 Kioicho, Chiyoda, Tokyo, Japan
TEL
03-6898-7145
Homepage URL
mtakuma@yahoo-corp.jp
Sponsor or person
Institute
Yahoo Japan Corporation
Institute
Department
Personal name
Funding Source
Organization
Yahoo Japan Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kirin Company, Limited
Name of secondary funder(s)
Kirin Company, Limited
IRB Contact (For public release)
Organization
Shiba Palace Clinic Research Ethics Committee
Address
Daiwa A Hamamatucho Bld., 1-9-10 Hamamatsucho, MInato-ku, Tokyo, Japan
Tel
03-5408-1599
jimukyoku@mail.souken-r.com
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
| 2017 | Year | 11 | Month | 13 | 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
226
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 | 10 | Month | 27 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 26 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 16 | Day |
Last follow-up date
| 2018 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 13 | Day |
Last modified on
| 2019 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034214
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
