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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025376
Receipt No. R000029220
Scientific Title A clinical study for evaluating safety of long-term consumption -Non-blind, safety verification study taking 1 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

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Basic information
Public title A clinical study for evaluating safety of long-term consumption
-Non-blind, safety verification study taking 1 times dose of test food "KW-01" in healthy adults.
Acronym A clinical study for evaluating safety of long-term consumption
-Non-blind, safety verification study taking 1 times dose of test food "KW-01" in healthy adults.
Scientific Title A clinical study for evaluating safety of long-term consumption
-Non-blind, safety verification study taking 1 times dose of test food "KW-01" in healthy adults.
Scientific Title:Acronym A clinical study for evaluating safety of long-term consumption
-Non-blind, safety verification study taking 1 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 long-term consumption of "KW-01" for 12 weeks (by taking 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 normal dose of test food for 84 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
Institute Kowa Company, Ltd.
Institute
Department

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 26 Day
Last follow-up date
2017 Year 05 Month 20 Day
Date of closure to data entry
2017 Year 05 Month 22 Day
Date trial data considered complete
2017 Year 05 Month 25 Day
Date analysis concluded
2017 Year 06 Month 19 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029220

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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