UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044005
Receipt number R000050252
Scientific Title Effects of consumption of the test food on liver function: A randomized double-blind placebo-controlled trial
Date of disclosure of the study information 2021/04/22
Last modified on 2022/08/10 16:51:35

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

ORTHOMEDICO Inc.

Institute

Department

Personal name



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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name