UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation for efficacy of liver function by ingestion of supplement containing plant derived extractive
Title of the study (Brief title)	Evaluation for efficacy of liver function by ingestion of supplement containing plant derived extractive
Region	Japan

Condition
Condition	Healthy subjects
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to evaluate for the efficacy of the supplement containing plant derived extractive on subjects with high normal liver function.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Biomarkers of liver function (ALT and AST) before and 4, 8, 12 weeks after the intervention with the test food
Key secondary outcomes	Biomarkers of liver function (gamma-GT and ALP), POMS2, LPO, Physical, Hematologic, Blood biochemical, Urinalysis, and Psychological values before and 4, 8, 12 weeks after the intervention with the test food

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake of supplement containing plant derived extractive for 12 consecutive weeks (4 capsules, 1 time a day)
Interventions/Control_2	Intake of placebo for 12 consecutive weeks (4 capsules, 1 time a day)
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	64 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Healthy males and females aged 20-64 years old 2.Subjects with BMI greater than 22.0 and less than 30 kg/m^2 3.Subjects who ALT levels were top 40 out of the participants applying to the criteria (both ALT and AST less than 50 U/L) 4.Subjects who has normal or borderline liver function judged by clinical investigator
Key exclusion criteria	1.Subjects who constantly use health food richly containing involvement ingredient 2.Subjects who constantly use supplements or drug affecting the liver function 3.Subjects with chronic illness or medication 4.Subjects who has serious illness such as diabetes, liver disease, kidney disease, heart disease 5.Subjects who are in danger of allergy to the study 6.Subjects who have participated in other clinical study within the last one month or have plan to participate other clinical studies 7.Subjects who are judged as unsuitable for the study from clinical measurements for preliminary tests and measurements 8.Subjects who are positive for HCV antibody or HbsAg 9.Subjects who intend to become pregnant or lactating 10.Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire 11.Subjects who are judged as ineligible by clinical investigator
Target sample size	40

Research contact person
Name of lead principal investigator	Yasuhiro Sato
Organization	Shiratori Pharmaceutical Co., Ltd.
Division name	Research and Development Dept
Address	2-3-7 Akanehama, Narashino-city, Chiba-pref
TEL	047-453-3161
Email	y-sato@shiratori-pharm.co.jp

Public contact
Name of contact person	Kotoha Isobe
Organization	TTC Co., Ltd.
Division name	Clinical Research Planning Department
Address	Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL	03-5459-5329
Homepage URL
Email	k.isobe@ttc-tokyo.co.jp

Sponsor
Institute	TTC Co., Ltd.
Institute
Department

Funding Source
Organization	Shiratori Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

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 05 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 05 Month 16 Day
Anticipated trial start date	2017 Year 05 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 05 Month 25 Day
Last modified on	2018 Year 06 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031509