UMIN-CTR Clinical Trial

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
Email	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
Email	IRB_dls@dena.com

Sponsor
Institute	DeNA Life Science Inc.
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038706