UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038821 |
|---|---|
| Receipt number | R000044261 |
| Scientific Title | Effects of 5-aminolevulinic acid supplementation on stress in healthy workers |
| Date of disclosure of the study information | 2019/12/07 |
| Last modified on | 2024/06/10 14:30:46 |
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Basic information
Public title
Effects of 5-aminolevulinic acid supplementation on stress in healthy workers
Acronym
Effects of 5-aminolevulinic acid supplementation on stress in healthy workers
Scientific Title
Effects of 5-aminolevulinic acid supplementation on stress in healthy workers
Scientific Title:Acronym
Effects of 5-aminolevulinic acid supplementation on stress in healthy workers
Region
| Japan |
Condition
Condition
healthy workers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the effects of 5-aminolevulinic acid intake on stress in healthy workers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
stress VAS(visual analog scale)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
5-aminolevulinic acid intake
washout period
Placebo intake
Interventions/Control_2
placebo intake
washout period
5-aminolevulinic acid intake
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
| 25 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.25-70age
2.Continuous worker over 6-monthes (over 30-hours per week)
3.Subjects with no physical disease and no psychiatric disorder
4.Subjects with no exercise habit
5.Subjects who want to participated in the study voluntarily and who agreed to participate.
Key exclusion criteria
1.History of psychiatric disorders
2.Above 16 CES-D score(Center for Epidemiologic Studies Depression Scale)
3.Subjects who are pregnant,breastfeeding
4.Subjects with photosensitivity(porphyria)
5.Subjects who are taking foods containing St.John's Wort
6.Subjects participated in other clinical trials within 3-monthes, or planning to participate in others during this study
7.Subjects judged by the investigator as inappropriate
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Suzuki |
Organization
Aoba-kokoro-no Clinic
Division name
director
Zip code
1700002
Address
2F 1-3-22, Sugamo, Toshima-ku, Tokyo, Japan
TEL
03-5981-0556
suzukiaoba@ybb.ne.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Suzuki |
Organization
Aoba-Promotion Co.,Ltd.
Division name
investigator
Zip code
1700002
Address
411 1-11-2, Sugamo, Toshima-ku, Tokyo, Japan
TEL
03-5976-0556
Homepage URL
aoba@jtrc-tokyo.com
Sponsor or person
Institute
Aoba-Promotion Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
SBI Pharmaceuticals Co., Ltd.
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
MINS Specified Nonprofit Corporation
Address
401 5-20-9, MIta, Minato-ku, Tokyo, Japan
Tel
03-6416-1868
npo-mins@j-irb.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
| 2019 | Year | 12 | Month | 07 | 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
| 2019 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 08 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 12 | Month | 07 | Day |
Last modified on
| 2024 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044261
