UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Verification test on improvement in a liver disorder marker and a cholesterol lowering effect
Title of the study (Brief title)	Verification test on improvement in a liver disorder marker and a cholesterol lowering effect
Region	Japan

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

Objectives
Narrative objectives1	To examine an influence of a test food product on improvement in a liver disorder marker and a cholesterol lowering effect by selecting healthy males and females aged 20 and over, below 65 who are not affected with a disease as subjects and assigning them to take the test food product for 12 weeks on a continuous basis.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	1.ALT 2.LDL-C
Key secondary outcomes	1.GAMMA-GTP 2.AST 3.TC 4.HDL-C 5.TG

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	12-week intake of the test food
Interventions/Control_2	12-week intake of the test food
Interventions/Control_3	12-week intake of the placebo food
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 giving written informed consent 2. Age: 20 and over, below 65 Males and females with Japanese nationality who are not affected with a disease 3. Persons who are able to drink 1 can of beverage per day for 12 weeks on a continuous basis 4.As liver function markers, ALT: 50 and below, GAMMA-GTP: 100 and below, AST: 50 or below 5. LDL-C: 120 to 159 mg/dl 6.Average pure alcohol intake per day for males: below 60 g, females: below 40 g
Key exclusion criteria	1. Currently in treatment with medication or seeing a doctor for treatment 2. Previous history of severe liver disorder (viral hepatitis, drug-induced liver injury, cirrhosis) or currently suspected to have liver disorder (a positive test result on hepatitis screening, etc.) 3. Previous history of liver disorder or severe disorder related to kidney, endocrine, cardiovascular system, gastrointestine, lung, blood, metabolism, or currently presence of complications 4. Previous history of a drug allergy and/or food allergy 5. Regular intake of a health food product or supplement possibly influencing the liver function and lowering cholesterol 6. Regular intake of medication possibly influencing the liver function and lowering cholesterol 7.Extreme faddiness 8. Extremely irregular lifestyle such as a dietary pattern and a sleeping pattern 9.Presence or previous history of mental disorder (depression, etc.) 10. A large volume of alcohol intake (average pure alcohol intake per day for males: 60 g or over, females: 40 g or over) 11.11) Current participation in another clinical trial or participation in another clinical trial within the last three months 12.Determined by the investigator to be unsuitable for enrollment in this study
Target sample size	69

Research contact person
Name of lead principal investigator	Ochitani Daisuke
Organization	HUMA R&D CORP
Division name	Clinical Development Division
Address	Oekkusu Bldg10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL	81-3-3431-1260
Email	ochitani@huma-c.co.jp

Public contact
Name of contact person	Ochitani Daisuke
Organization	HUMA R&D CORP
Division name	Clinical Development Division
Address	Oekkusu Bldg10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL	81-3-3431-1260
Homepage URL
Email	ochitani@huma-c.co.jp

Sponsor
Institute	HUMA R&D CORP
Institute
Department

Funding Source
Organization	Asahi Group Holdings,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 09 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 07 Month 14 Day
Anticipated trial start date	2017 Year 08 Month 30 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 08 Month 25 Day
Last modified on	2018 Year 03 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033006