UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of continuous ingestion of trial supplement on liver function. - A randomized, placebo-controlled, double-blind, parallel-group clinical trial -
Title of the study (Brief title)	A clinical trial to study the effect of trial supplement on liver function.
Region	Japan

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

Objectives
Narrative objectives1	To investigate the effect of the trial supplement on maker of liver function.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	AST : Aspartate Aminotransferase ALT : Alanine Aminotransferase Gamma-GT : Gamma-Glutamic Transpeptidase Point:0w, 4w, 8w, 12w
Key secondary outcomes

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	Treatment
Type of intervention	Food
Interventions/Control_1	Test food contained silymarin and curcumin, 4 tablets once day for 12weeks.
Interventions/Control_2	Control food not contained silymarin and curcumin, 4 tablets once a day for 12weeks.
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	Male and Female
Key inclusion criteria	1) Subjects that any one or more of the AST, ALT or gamma-GTP corresponds to criterion of JAPAN SOCIETY OF NINGEN DOCK. However, gamma-GTP of women is half of the value of setting limits. 2)Subjects who giving written informed consent
Key exclusion criteria	1)Subjects who are judged as unsuitable for the study by the investigator for AST, ALT, gamma-GTP. 2)Subjects who take drug having an effect on improvement of liver function. 3)Subjects who consecutively take dietary supplement or food including silymarin or curcumin (more than three times a week for more than half year). 4)Subjects who consecutively take dietary supplement or food and can't stop those foods from one week before to the end of the study. 5)Subjects who have allergy to silymarin, (extract of Silybum marianum) or curcumin (extract of Curcuma longa). 6)Subjects who have or had severe disorders (for example, liver function, kidney function, heart function, diabetes etc.) or thyroid disease, adrenal disease and other metabolic diseases. 7)Subjects who have chronic disease and consecutively use drug. 8)Subjects who have excessive drinking habits (apply to the following conditions). More than 100g alcohol consumption per day. More than 80g less than 100g alcohol consumption per day and drinking frequency is five days a week or more. More than 60g less than 80g alcohol consumption per day and drinking frequency is each day. 9)Subjects whose ifestyle is extremely irregular (for exsample, night work, day and night reversed style) 10)Subjects suffer from addiction to the drug or alcohol. 11)Subjects who are planned to participate in other clinical study. 12)Female with pregnancies, lactating or planning to become pregnant during the study. 13)Subjects who are judged as unsuitable for the study by the investigator for other reason.
Target sample size	100

Research contact person
Name of lead principal investigator	Yoshitaka Iwama
Organization	Nihonbashi Cardiology Clinic
Division name	Director
Address	13-4 Kodenma-cho, Chuo-ku, Tokyo, Japan
TEL	03-5641-4133
Email	yiwama@well-sleep.jp

Public contact
Name of contact person	Eiji Yoshikawa
Organization	KSO Corporation
Division name	Sales department
Address	1-9-7 Shibaura, Minato-ku, Tokyo, Japan
TEL	03-3452-7733
Homepage URL
Email	yoshikawa@kso.co.jp

Sponsor
Institute	KSO Corporation
Institute
Department

Funding Source
Organization	FANCL Corporation
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	医療法人財団健康睡眠会 日本橋循環器科クリニック(Nihonbashi Cardiology Clinic)

Other administrative information
Date of disclosure of the study information	2016 Year 12 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 04 Day
Anticipated trial start date	2016 Year 08 Month 22 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	2016 Year 08 Month 03 Day
Last modified on	2017 Year 02 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027030