UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of effects of test food intake on liver function and ALT in healthy volunteers
Acronym	Effects of test food intake on liver function and ALT
Scientific Title	Effects of food intake on liver function and ALT
Scientific Title:Acronym	Effects on liver function and ALT
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 test foods on serum ALT changes and liver function improvement in healthy individuals with high ALT
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Measured ALT value and ALT change amount
Key secondary outcomes	1)Measured AST value 2)Measured GGT value 3)Measured type4collagen7s value 4)Measured Ferritin value 5)Liver disease scoring

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation	YES
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	4
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Take control food for 12 weeks
Interventions/Control_2	Take test food once a day for 12 weeks
Interventions/Control_3	Take test food twice a day for 12 weeks
Interventions/Control_4	Take test food 4 times a day for 12 weeks
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	45 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	1)Person who are registered in Shinanokai clinical trial volunteer association 2)Healthy persons aged 45 to under 75 3)Person with serum ALT of 31 to 50 IU/L at observation period 1 and observation period 2 (before ingestion) 4)Person who can obtain written consent from the person
Key exclusion criteria	1)Person who continue to take prescription drugs 2)Person who are on diet or exercise therapy 3)Pregnant women, lactating women and person who have or are willing to become pregnant 4)Person who are unable to comply with the intake management of test foods 5)Person who are allergic to the test food 6)Person who have participated in other clinical trials within the past 3 months 7)Person who have taken Misatol or commercial plum extract within the past 3 months 8)Person who regularly take functional foods related to liver function improvement 9)Others, a person who is judged unfit by the physician in charge of this study
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Kenji Middle name Last name Takazawa
Organization	Shinanozaka Clinic
Division name	Derector of a clinic
Zip code	160-0017
Address	Yotsuya Medical Building 3F, 20 SAmon-cho, Shinjuku-ku
TEL	0353663006
Email	takazawa@shinanokai.com

Public contact
Name of contact person	1st name Mikio Middle name Last name Sasaki
Organization	Shinanozaka Clinic
Division name	Clinical Trial Department
Zip code	160-0017
Address	Yotsuya Medical Building 3F, 20 SAmon-cho, Shinjuku-ku
TEL	0353663006
Homepage URL
Email	m-sasaki@shinanokai.com

Sponsor
Institute	Shinanozaka Clinic
Institute
Department

Funding Source
Organization	Otsuka Pharmaceutical Factory, Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Shinanozaka Clinic Ethics Committee
Address	Yotsuya Medical Building 3F, 20 SAmon-cho, Shinjuku-ku
Tel	0353663006
Email	m-iwasaki@shinanokai.com

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	2020 Year 08 Month 26 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	2020 Year 07 Month 17 Day
Date of IRB	2020 Year 07 Month 29 Day
Anticipated trial start date	2020 Year 08 Month 27 Day
Last follow-up date	2021 Year 06 Month 30 Day
Date of closure to data entry	2021 Year 07 Month 01 Day
Date trial data considered complete	2021 Year 07 Month 01 Day
Date analysis concluded	2021 Year 07 Month 01 Day

Other
Other related information

Management information
Registered date	2020 Year 08 Month 26 Day
Last modified on	2021 Year 10 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047305