UMIN-CTR Clinical Trial

Basic information
Public title	Effect of supplement on liver. -A placebo-controlled, randomized, double-blind, parallel-group comparative study-
Acronym	Effect of supplement on liver.
Scientific Title	Effect of supplement on liver. -A placebo-controlled, randomized, double-blind, parallel-group comparative study-
Scientific Title:Acronym	Effect of supplement on liver.
Region	Japan

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

Objectives
Narrative objectives1	To investigate the effect of supplement on liver.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Liver fat content
Key secondary outcomes	ALT : Alanine Aminotransferase AST : Aspartate Aminotransferase Gamma-GT : Gamma-Glutamic Transpeptidase Low Density Lipoprotein cholesterol High Density Lipoprotein cholesterol Triglyceride Body Weight Body Mass Index Body Fat Percentage

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	No need to know

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Test food(Intake period:24 weeks)
Interventions/Control_2	Control food (Intake period:24 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	Male and Female
Key inclusion criteria	1.Japanese male and female aged between 20 to 65 years old at the time of informed consent. 2.Subjects whose BMI is between 25.0 to 30.0 kg/m2. 3.Subjects who agreed to participate in the study on one's own will.
Key exclusion criteria	1.Subjects whose liver stiffness is more than 6.0 kPa. 2.Subjects who had liver disease, or have currently under medical treatment of the liver disease. 3.Subjects who are currently undergoing treatment for serious diseases. 4.Subjects who have average intake of alcohol more than 60 g/day by week. 5.Subjects who have food allergies or who may be allergic to the test food. 6.Subjects who are taking drugs and quasi-drugs that may affect the current study. 7.Subjects who regularly take health foods that may affect the current study. 8.Subjects who will not stop taking the drugs, quasi-drugs and health foods during the study period (after agreeing to the informed consent until the end of the test food ingestion period). 9.Subjects who have extremely irregular lifestyles. 10.Subjects who are currently participating in other studies, or participated in other studies within the past 3 months from the time of the informed consent. 11.Subjects who participate in other studies during this study. 12.Subjects who will not maintain their daily routines. 13.Subjects who have difficulty in taking the test food as instructed. 14.Subjects who are pregnant or breastfeed, or planning to become pregnant during this study 15.Subjects who are consideredas unsuitable participant for the study by the doctor and investigator.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Sayuri Middle name Last name Matsuoka
Organization	FANCL Corporation
Division name	Research Institute, Health science research center
Zip code	244-0806
Address	12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa, Japan
TEL	045-820-3532
Email	ke-yui@fancl.co.jp

Public contact
Name of contact person	1st name Yuki Middle name Last name Kitahara
Organization	APO PLUS STATION CO., LTD.
Division name	CRO Department Clinical Operations Division
Zip code	103-0027
Address	2-14-1,Nihonbashi,Chuo-ku,Tokyo, Japan
TEL	03-6386-8809
Homepage URL
Email	food-contact@apoplus.co.jp

Sponsor
Institute	APO PLUS STATION CO., LTD.
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)

IRB Contact (For public release)
Organization	Hitachi Omika Hospital
Address	2-22-30,Omika-cho,Hitachi-shi,Ibaraki-ken
Tel	029-487-9111
Email	masaki.ohata@medical-art.co.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	医療法人社団盟生会　東新宿クリニック

Other administrative information
Date of disclosure of the study information	2022 Year 10 Month 31 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	2021 Year 09 Month 27 Day
Date of IRB	2021 Year 10 Month 09 Day
Anticipated trial start date	2021 Year 10 Month 18 Day
Last follow-up date	2022 Year 08 Month 12 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 10 Month 15 Day
Last modified on	2022 Year 11 Month 16 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052247