UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039319
Receipt number R000044847
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 2020/01/30
Last modified on 2021/01/22 08:54:42

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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 or person

Institute

ORTHOMEDICO Inc.

Institute

Department

Personal name



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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name