UMIN-CTR Clinical Trial

Basic information
Public title	Validation study on the effects on liver function and skin barrier function by intake of adlay
Acronym	Validation study on the effects on liver function and skin barrier function by intake of adlay
Scientific Title	Validation study on the effects on liver function and skin barrier function by intake of adlay
Scientific Title:Acronym	Validation study on the effects on liver function and skin barrier function by intake of adlay
Region	Japan

Condition
Condition	Healthy Adults
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluate the effects of liver function and skin barrier function by adlay tea intake for 8 weeks.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	-liver function (AST, ALT, gamma-GTP ) -skin hydration (Transepidermal water loss, Moisture) At the beginning of the test or after the intake for 8 weeks.
Key secondary outcomes	-Blood test (total protein, albumin, ,blood neutral fat (TG), total cholesterol, HDL-cholesterol, LDL-cholesterol, urea nitrogen , ALP, CPK, total bilirubin, uric acid, urea nitrogen, creatinine, sodium, potassium, chlorine, calcium, phosphorus, magnesium, LDH, white blood cell count, red blood cell count, hemoglobin, hematocrit, platelet count, MCV, MCH, MCHC) -Physical examination (body height, weight, BMI, blood pressure, pulse) -Food questionnaire

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	Intake 500mL of adlay tea daily for 8 weeks.
Interventions/Control_2	Intake 500ml of barley tea daily 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	65 years-old >
Gender	Female
Key inclusion criteria	1.Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document 2.Japanese women who are 20 years old or more and under 65 years old 3.Persons who are the bottom 70 of the value of skin hydration at screening
Key exclusion criteria	1.Persons who have chronic illness, receiving medication, have a serious disease history 2.Persons who are allergic to the test food 3.Persons who usually take a large amount of test food 4.Persons whose ALT or AST is over 51 U/L at screening 5.Persons whose gamma-GTP is over 101 U/L at screening 6.Persons whose habitually consume higher amount of alcohol (>60g alcohol/day) 7.Persons who have skin disease such as atopic dermatitis, urticaria, eczema and dermatitis. 8.Persons who regularly use medicines, specified insurance foods, health foods, etc. that may affect liver function and skin function 9.Persons who have participated in other tests within the first month before the start of the test, or those who intend to participate in another exam after consenting to this exam 10.Persons who are pregnant, planning or hoping to be pregnant during the study period, breastfeeding 11.Persons who were judged as inappropriate for subjects by the principal investigator
Target sample size	70

Research contact person
Name of lead principal investigator	1st name Hirohito Middle name Last name Ishikawa
Organization	Healthcare Systems Co., Ltd.
Division name	Research and Development Department
Zip code	105-0004
Address	Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL	03-6809-2722
Email	ishikawa@hc-sys.jp

Public contact
Name of contact person	1st name Hitomi Middle name Last name Izumi
Organization	Healthcare Systems Co., Ltd.
Division name	Research and Development Department
Zip code	105-0004
Address	Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL	03-6809-2722
Homepage URL
Email	izumi@hc-sys.jp

Sponsor
Institute	Healthcare Systems Co., Ltd.
Institute
Department

Funding Source
Organization	Cabinet Office
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization

Other related organizations
Co-sponsor	Oyama city
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The Ethics Committee of Healthcare Systems Co., Ltd.
Address	Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
Tel	03-6809-2722
Email	soumu@hc-sys.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	2020 Year 07 Month 15 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	70
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	2020 Year 06 Month 18 Day
Date of IRB	2020 Year 06 Month 18 Day
Anticipated trial start date	2020 Year 08 Month 08 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 07 Month 15 Day
Last modified on	2021 Year 01 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046947