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

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

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

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

Central registration

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

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

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

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

Theravalues Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Medical Corporation Seishinkai, Takara 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

info@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)

Date of disclosure of the study information

2020

Year

01

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2020

Year

01

Month

30

Day

Last modified on

2021

Year

01

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044847