UMIN-CTR Clinical Trial

Basic information
Public title	Effects of consumption of the test food on liver function
Acronym	Effects of consumption of the test food on liver function
Scientific Title	Effects of consumption of the test food on liver function: A randomized double-blind placebo-controlled trial
Scientific Title:Acronym	Effects of consumption of the test food on liver function
Region	Japan

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

Objectives
Narrative objectives1	To verify the effects of consumption of the test food on liver function, fatigue and sleep in healthy Japanese subjects.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The measured values of serum alanine aminotransferase (ALT) at eight weeks after the start of test-food consumption (8w)
Key secondary outcomes	1. The ratio of number of subjects whose serum ALT at 8w is 30 U/L or under 2. The ratio of number of subjects whose serum ALT before test-food consumption is between 31 U/L or over and 40 U/L or under and whose serum ALT at 8w is 30 U/L or under, and subjects whose serum ALT before test-food consumption is between 41 U/L or over and 50 U/L or under and whose serum ALT at 8w is 40 U/L or under 3. The measured values of serum ALT at four weeks after the start of test-food consumption (4w) 4. The change of serum ALT between before test-food consumption and at 4w and 8w 5-1. The measured values of serum asparate aminotransferase (AST) and gamma-glutamyltranspeptidase (gamma-GT) at 4 and 8 weeks after the start of test-food consumption (4w and 8w) 5-2. The change of serum AST and gamma-GT between before test-food consumption and at 4w and 8w 6-1. The measured values of Visual Analogue Scale (VAS) of fatigue at 2w, 4w, 6w and 8w 6-2. The change of VAS of fatigue between before test-food consumption and at 2w, 4w, 6w and 8w 7-1. The measured values of OSA sleep inventory MA version at 2w, 4w and 8w 7-2. The change of OSA sleep inventory MA version between before test-food consumption and at 2w, 4w and 8w

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	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Duration: eight weeks Test food: CR-033P Dose: Take 2 capsules of the test food per day Administration: Take 1 capsule of the test food with water before 10 to 15 minutes in breakfast and dinner *If you forget to take the test food, take it as soon as you remember within the day.
Interventions/Control_2	Duration: eight weeks Test food: placebo Dose: Take 2 capsules of the test food per day Administration: Take 1 capsule of the test food with water before 10 to 15 minutes in breakfast and dinner *If you forget to take the test food, take it as soon as you remember within the day.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Healthy Japanese adult subjects 2. Subjects who are judged as eligible to participate in the study by the physician 3. Subjects whose serum ALT are 31 U/L or more and 50 U/L or under.
Key exclusion criteria	1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. Subjects who have a history of the severe liver disorder (viral hepatitis, drug-induced liver injury, cirrhosis) or are currently suspected to have a liver disorder (a positive test result on hepatitis screening, etc.) 3. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 4. Currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, bladder diseases, or any other chronic diseases 5. Subjects who suffered or have been suffered from diseases related to the biliary tract 6. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily 7. Currently taking medicines and/or herbal medicines, particularly using anticoagulants such as Warfarin. 8. Subjects who are allergic to medicines and/or the test food related products 9. Subjects who are pregnant, breast-feeding, and planning to become pregnant 10. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial 11. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size	68

Research contact person
Name of lead principal investigator	1st name Kazuo Middle name Last name YAMAMOTO
Organization	ORTHOMEDICO Inc.
Division name	CEO
Zip code	112-0002
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL	03-3818-0610
Email	kazu@orthomedico.jp

Public contact
Name of contact person	1st name Naoko Middle name Last name SUZUKI
Organization	ORTHOMEDICO Inc.
Division name	R&D Department
Zip code	112-0002
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL	03-3818-0610
Homepage URL
Email	nao@orthomedico.jp

Sponsor
Institute	ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization	Theravalues Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Medical Corporation Seishinkai, Takara Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization	the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address	9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel	03-5793-3623
Email	info@takara-clinic.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	医療法人社団盛心会 タカラクリニック (東京都) Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

Other administrative information
Date of disclosure of the study information	2020 Year 01 Month 30 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	68
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 01 Month 24 Day
Date of IRB	2020 Year 01 Month 24 Day
Anticipated trial start date	2020 Year 01 Month 31 Day
Last follow-up date	2020 Year 07 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 01 Month 30 Day
Last modified on	2021 Year 01 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044847