UMIN-CTR Clinical Trial

Basic information
Public title	Effect of 12-week continuous ingestion of the supplement on liver function.-A placebo-controlled, randomized, double-blind, parallel-group comparative study-
Acronym	Effect of 12-week continuous ingestion of the supplement on liver function.
Scientific Title	Effect of 12-week continuous ingestion of the supplement on liver function.-A placebo-controlled, randomized, double-blind, parallel-group comparative study-
Scientific Title:Acronym	Effect of 12-week continuous ingestion of the supplement on liver function.
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 12 weeks continuous ingestion of trial supplement on liver function.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	ALT : Alanine Aminotransferase
Key secondary outcomes	AST : Aspartate Aminotransferase Gamma-GTP : Gamma-Glutamic Transpeptidase

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
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:12 weeks)
Interventions/Control_2	Control food (Intake period:12 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.Male and female aged between 20 to 64 years old at the time of informed consent. 2.Subjects whose BMI is between the range of 25 and 29 kg/m2. 3.Subjects whose ALT is between 31 to 50 U/+-10% at the time of the screening test 1. 4.Subjects whose ALT is between 31 to 50 U/L+-10% at the time of the screening test 2. 5.Subjects who agree to participate in the study on one's own will.
Key exclusion criteria	1.Subjects whose AST is above 50 U/L and/or Gamma-GTP above 100 U/L at the time of the screening test 2. 2.Subjects who have history of liver disease, or is currently under medical treatment of the liver disease. 3.Subjects who are suffering or suffered from serious disease in the past. 4.Subjects who have average intake of alcohol more than 59 g per 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 are taking health foods that may affect the current study. 8.Subjects who cannot stop taking the drugs, quasi-drugs and health foods during the study period (after agreeing to the informed consent until the end of the 12-week test food ingestion period). 9.Subjects who have extremely irregular lifestyles. 10.Subjects who are currently participating in other studies, or participating in other studies within the past 3 months from the time of the informed consent. 11.Subjects who are planning to participate in other studies during this study. 12.Subjects who are pregnant, or planning to become pregnant or breastfeed during this study. 13.Subjects who are judged as unsuitable participant for the study by the doctor and investigator.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Kei Middle name Last name Yui
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	045-820-3755
Email	ke-yui@fancl.co.jp

Public contact
Name of contact person	1st name Eiji Middle name Last name Yoshikawa
Organization	KSO Corporation
Division name	Sales department
Zip code	105-0023
Address	1-9-7 Shibaura, Minato-ku, Tokyo
TEL	03-3452-7733
Homepage URL
Email	eigyou27@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)

IRB Contact (For public release)
Organization	Ethical Committee of Nihonbashi Cardiology Clinic
Address	Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
Tel	03-5641-4133
Email	niho-jimucho@well-sleep.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	医療法人財団健康睡眠会　日本橋循環器科クリニック

Other administrative information
Date of disclosure of the study information	2021 Year 06 Month 11 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	100
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 05 Month 11 Day
Date of IRB	2021 Year 04 Month 06 Day
Anticipated trial start date	2021 Year 06 Month 12 Day
Last follow-up date	2021 Year 11 Month 07 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 06 Month 10 Day
Last modified on	2022 Year 03 Month 30 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050832