UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032641
Receipt number R000037220
Scientific Title A verification study of safety evaluation of the test food long-term administration in humans: a randomized, double-blind, placebo-controlled, parallel study
Date of disclosure of the study information 2018/05/18
Last modified on 2019/02/08 12:26:47

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Basic information

Public title

A verification study of safety evaluation of the test food long-term administration in humans: a randomized, double-blind, placebo-controlled, parallel study

Acronym

A verification study of safety evaluation of the test food long-term administration in humans

Scientific Title

A verification study of safety evaluation of the test food long-term administration in humans: a randomized, double-blind, placebo-controlled, parallel study

Scientific Title:Acronym

A verification study of safety evaluation of the test food long-term administration in humans

Region

Japan


Condition

Condition

Healthy Japanese subjects

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To identify the safety of long-term administration of the recommended daily intake of test food for 12 weeks

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

1. Physical examination
2. Urinalysis
3. Blood test
4. Subjective symptoms (the Likert scale)

* Assess these tests at screening and examination before consumption and at 4, 8, and 12 weeks after consumption

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Duration: 12 weeks
Test material: Active capsules
Dose: 2 capsules per day
Administration: Take one capsule with water after breakfast and another capsule after dinner
* Daily dose should be taken within the day. If you forget to take the capsules, take it as soon as you remember within the day.

Interventions/Control_2

Duration: 12 weeks
Test material: Placebo capsules
Dose: 2 capsules per day
Administration: Take one capsule with water after breakfast and another capsule after dinner
* Daily dose must be taken within the day. If you forget to take the capsules, 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

Key exclusion criteria

1. A medical history of malignant tumor, heart failure or myocardial infarction

2. Currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver failure, kidney failure, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, urinary bladder failure, or any other chronic diseases

3. Subjects who suffered or have been suffered from diseases related to the biliary tract

4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily

5. Subjects who currently taking medications (including herbal medicines) and supplements, particularly taking anticoagulants such as warfarin

6. Subjects who eat natto more than 3 times per week

7. Subjects who are allergic to medicines and/or the test food related products

8. Subjects who are pregnant, breast-feeding, and planning to become pregnant

9. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial

10. Subjects who are judged as ineligible to participate in the study by the physician

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuo YAMAMOTO

Organization

ORTHOMEDICO Inc.

Division name

CEO

Zip code


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
Middle name
Last name Naoko SUZUKI

Organization

ORTHOMEDICO Inc.

Division name

R&D Department

Zip code


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


Address


Tel


Email



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

2018 Year 05 Month 18 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

2018 Year 05 Month 08 Day

Date of IRB


Anticipated trial start date

2018 Year 05 Month 19 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 05 Month 18 Day

Last modified on

2019 Year 02 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037220


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name