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	Effects of consumption of supplements containing the plant-derived ingredient on the improvement of liver function
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 24 weeks after the start of test-food consumption (24w)
Key secondary outcomes	1. The measured values of serum ALT at four and 12 weeks after the start of test-food consumption (4w and 12w) 2. The change of serum ALT from screening (Scr) to after intervention (Scr to four weeks after the start of test-food consumption [4w], Scr to 12w, and Scr to 24w) 3. The change of serum ALT from before consumption (0w) to after intervention (Scr to 4w, Scr to 12w, and Scr to 24w) 4. The measured values of serum asparate aminotransferase (AST), gamma-glutamyltranspeptidase (GT) and glutathione at 4w, 12w and 24w 5. The change of serum AST, gamma-GT and glutathione from Scr to after intervention (Scr to 4w, Scr to 12w, and Scr to 24w) 6. The change of serum AST, gamma-GT and glutathione from 0w to after intervention (Scr to 4w, Scr to 12w, and Scr to 24w) 7. The ratio of number of subjects whose serum ALT at Scr is between 31 U/L or over and 40 U/L or under and whose serum ALT at 24w is 30 U/L or under, and subjects whose serum ALT at Scr is between 41 U/L or over and 50 U/L or under and whose serum ALT at 24w is 40 U/L or under

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Duration: 24 weeks Test food: Supplements containing the plant-derived ingredient (the plant-derived ingredient 10 mg/capsule) Administration: Take six capsules per day at after breakfast with approximately 100 mL of water *If you forget to take the test food at after breakfast, take it as soon as you remember within the day.
Interventions/Control_2	Duration: 24 weeks Test food: Placebo (without the plant-derived ingredient) Administration: Take six capsules per day at after breakfast with approximately 100 mL of water *If you forget to take the test food at after breakfast, 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	45 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	1. Japanese 2. Men or women 3. Subjects aged 45 or more and less than 65 4. Healthy subjects 5. Subjects who are judged as eligible to participate in the study by the physician 6. Subjects whose serum ALT are 31U/L or more and 50U/L or under at Scr 7. Subjects whose serum AST are 50U/L or under at Scr 8. Subjects whose serum gamma-GT are 100U/L or under at Scr
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 pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects who currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, hepatitis B, hepatitis C, or any other chronic diseases 4. Subjects who have a habit of drinking an average of 60 g or more of pure alcohol per day on a weekly 5. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily 6. Subjects who currently taking medications (including herbal medicines) and supplements 7. Subjects allergic to medications and/or the test-food-related products. Particularly allergic to shrimp, crab, egg, wheat, soba (buckwheat), peanut, and milk 8. Subjects who are pregnant, lactation, or planning to become pregnant 9. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 10. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size	74

Research contact person
Name of lead principal investigator	1st name Tsuyoshi Middle name Last name Takara
Organization	Medical Corporation Seishinkai, Takara Clinic
Division name	Director
Zip code	141-0022
Address	9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
TEL	03-5793-3623
Email	t-takara@takara-clinic.com

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	KAGOME CO.,LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi 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	IRB@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) 南町医院 (東京都) Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)

Other administrative information
Date of disclosure of the study information	2021 Year 04 Month 22 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 04 Month 14 Day
Date of IRB	2021 Year 04 Month 14 Day
Anticipated trial start date	2021 Year 04 Month 22 Day
Last follow-up date	2021 Year 12 Month 04 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 04 Month 21 Day
Last modified on	2022 Year 08 Month 10 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050252