UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025377
Receipt number R000029217
Scientific Title A clinical study for evaluating safety of excessive consumption -Non-blind, safety verification study taking 5 times dose of test food "KW-01" in healthy adults.
Date of disclosure of the study information 2017/01/23
Last modified on 2017/09/08 16:28:05

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Basic information

Public title

A clinical study for evaluating safety of excessive consumption
-Non-blind, safety verification study taking 5 times dose of test food "KW-01" in healthy adults.

Acronym

A clinical study for evaluating safety of excessive consumption
-Non-blind, safety verification study taking 5 times dose of test food "KW-01" in healthy adults.

Scientific Title

A clinical study for evaluating safety of excessive consumption
-Non-blind, safety verification study taking 5 times dose of test food "KW-01" in healthy adults.

Scientific Title:Acronym

A clinical study for evaluating safety of excessive consumption
-Non-blind, safety verification study taking 5 times dose of test food "KW-01" in healthy adults.

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We verify safety of excessive consumption of "KW-01" for 4 weeks (by taking 5 times of its normal dose).

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

-Appearance of adverse events
-Height, weight and BMI
-Body temperature, blood pressure and pulse
-12-lead electrocardiogram
-General hematology test
-Blood biochemistry test
-Urinalysis

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Intake 5 times of normal dose of test food for 28 days, every day

Interventions/Control_2


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

45 years-old >=

Gender

Male and Female

Key inclusion criteria

Target subject must satisfy the following selection criteria.
1) Healthy Japanese aged from 20 to 45 years-old at the time of giving informed consent
2) A person who is not using chronic or seasonal drugs or medical equipment and is not undergoing rehabilitation therapy
3) A person who has freely given informed consent and has fully understood the purpose of the study
4) A person whose BMI is from 18.5 to 30.0
5) When measuring blood pressure twice, a person whose average blood pressure is within a range of followings;Systolic blood pressure: less than or equal to 139mmHg
Diastolic blood pressure: less than or equal to 89mmHg
6) A person whose pulse rate is from 40 to 100 per minute
7) A person whose body temperature is from 35.5 to 37.0 degree Celsius
8) A person who can prevent from excessive exercise during the study
9) A person who can basically have 3 meals in a day during the study
10) A person who can conduct contraception by appropriate ways during the study
11) A person who understands and follows rules and requirements during the study
12) A person who is considered totally fit for participating the study by a comprehensive judgement of lead principal investigator and others.

Key exclusion criteria

The following exclusion criteria apply to subjects.
1) A person with the disease in gastrointestinal tract, liver, kidney, heart and circulatory system which have an influence on the absorption, distribution, metabolism and excretion of test food
2) A person with a major surgery history in the gastrointestinal tract sites such as gastrectomy, stomach and intestines suture, the intestinal resection (however, polypectomy, the a ppendectomy are excluded)
3) A person with a history of cerebrovasculardisorder (the asymptomatic lacunar infarct is excluded)
4) A person with tattoo which has an influence on the study because of its size or range
5) A person with hypersensitivity or idiosyncrasy, such as food allergy
6) A person who is suspected to have alcohol or drug dependence
7) A person who has participated in other clinical trials within 84 days from giving an informed consent
8) A person who donated 400 ml of blood within 84 days, 200 ml within 28 days, or a blood component (plasma or platelets) within 14 days from giving an informed consent
9) A person who hopes pregnancy or who cannot prevent conception during the study
10) A nursing or pregnant woman
11) A person who is engaged in night duty

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akihito Yoshida

Organization

MEDOC Medical Dock & Clinic

Division name

internal medicine

Zip code


Address

4-3, Yasudadori, Showa-ku, Nagoya-shi

TEL

052-752-1135

Email

chiken@medoc.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiromichi Hayashi

Organization

Medeical Fusion Co.,Ltd.

Division name

Clinical development division

Zip code


Address

Nagoya mechanic cooperation incubator, 2-2 2-8, Chikusa, Chikusa-ku, Nagoya-shi

TEL

052-745-3300

Homepage URL

http://www.m-fusion.co.jp/

Email

info@m-fusion.co.jp


Sponsor or person

Institute

Kowa Company, Ltd.

Institute

Department

Personal name



Funding Source

Organization

Kowa Company, Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


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 メドック健康クリニック(愛知県)


Other administrative information

Date of disclosure of the study information

2017 Year 01 Month 23 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

2016 Year 12 Month 16 Day

Date of IRB


Anticipated trial start date

2017 Year 01 Month 30 Day

Last follow-up date

2017 Year 03 Month 25 Day

Date of closure to data entry

2017 Year 03 Month 27 Day

Date trial data considered complete

2017 Year 04 Month 12 Day

Date analysis concluded

2017 Year 04 Month 24 Day


Other

Other related information



Management information

Registered date

2016 Year 12 Month 22 Day

Last modified on

2017 Year 09 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029217


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name