UMIN-CTR Clinical Trial

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

Healthy Japanese subjects

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

ORTHOMEDICO Inc.

Institute

Department

Personal name

Organization

KAGOME CO.,LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Medical Corporation Seishinkai, Takara Clinic

Nerima Medical Association, Minami-machi Clinic

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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)

Date of disclosure of the study information

2021

Year

04

Month

22

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2021

Year

04

Month

21

Day

Last modified on

2022

Year

08

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050252