UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033937 |
|---|---|
| Receipt number | R000038706 |
| Scientific Title | A study of evaluating the effect of oral intake of BARLEYmax on human skin condition. A randomized, double-blind, placebo-controlled trial. |
| Date of disclosure of the study information | 2021/04/01 |
| Last modified on | 2021/06/11 18:21:36 |
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Basic information
Public title
A study of evaluating the effect of oral intake of BARLEYmax on human skin condition. A randomized, double-blind, placebo-controlled trial.
Acronym
The study of BARLEYmax on human skin condition.
Scientific Title
A study of evaluating the effect of oral intake of BARLEYmax on human skin condition. A randomized, double-blind, placebo-controlled trial.
Scientific Title:Acronym
The study of BARLEYmax on human skin condition.
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of BARLEYmax on human skin condition.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questionnaires regarding to skin condition
Key secondary outcomes
Questionnaires regarding to feces and systemic health
Blood test(IgE, TARC, eosinophil)
Gut microbiota
Free description
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
Placebo, 12 g/d for 8 weeks
Interventions/Control_2
BARLEYmax, 12 g/d for 8 weeks
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Individuals aged more than 20 years old.
(2)The subjects who agreed with the consent of MYCODE research.
Key exclusion criteria
(1)Individuals who are participating in other clinical trials.
(2)Individuals who may develop allergic symptoms due to wheat.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jun Oi |
Organization
DeNA Life Science Inc.
Division name
R&D Gr.
Zip code
Address
Shibuya-Hikarie, 2-21-1, Shibuya, Sibuya-Ku, Tokyo, Japan
TEL
03-4366-7219
IRB_dls@dena.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Fujitomo |
Organization
DeNA Life Science Inc.
Division name
R&D Gr.
Zip code
Address
Shibuya-Hikarie, 2-21-1, Shibuya, Sibuya-Ku, Tokyo, Japan
TEL
03-4366-7219
Homepage URL
IRB_dls@dena.com
Sponsor or person
Institute
DeNA Life Science Inc.
Institute
Department
Personal name
Funding Source
Organization
Teijin Limited
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
Address
Tel
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
| 2021 | Year | 04 | Month | 01 | 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
| 2018 | Year | 08 | Month | 23 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 23 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 30 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 29 | Day |
Last modified on
| 2021 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038706
| 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 |
