UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019159 |
|---|---|
| Receipt number | R000022154 |
| Scientific Title | Non-blinded safety verification test using a dose of the test food "EMFCTR-01" five times higher than that intended for healthy individuals |
| Date of disclosure of the study information | 2015/10/02 |
| Last modified on | 2017/09/08 16:12:54 |
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Basic information
Public title
Non-blinded safety verification test using a dose of the test food "EMFCTR-01" five times higher than that intended for healthy individuals
Acronym
Non-blinded safety verification test using a dose of the test food "EMFCTR-01" five times higher than that intended for healthy individuals
Scientific Title
Non-blinded safety verification test using a dose of the test food "EMFCTR-01" five times higher than that intended for healthy individuals
Scientific Title:Acronym
Non-blinded safety verification test using a dose of the test food "EMFCTR-01" five times higher than that intended for healthy individuals
Region
| Japan |
Condition
Condition
Healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will check about safety while people take usual "EMFCTR-01" excessively for 4 weeks. We evaluated safety through physical examinations (interviews, auscultation, percussion, inspection, palpation, etc.) and changes in clinical laboratory values from the baseline evaluation (vist0) to the second evaluation (visit2) or post evaluation.
Basic objectives2
Others
Basic objectives -Others
We verified the effects of "EMFCTR-01" on other parameters, including organ functionality, through, physical examinations (interview, auscultation, percussion, inspection, palpation, etc.). antioxidative effect, oxidative stress level and changes in clinical laboratory values from the baseline evaluation (visit0) to the second evaluation (visit2) or post evaluation.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse events
Key secondary outcomes
-Body mass index(BMI)
-Blood pressure/pulse/body temperature
-General blood test
-Biochemical examination
-Antioxidative effect and oxidative stress level
-Urinalysis
-12-lead electrocardiogram
-Stool characteristics, stool frequency, stool output
-Meal recording
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
SAFETY
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 subjects must satisfy the following selection criteria.
1) Healthy Japanese men and women aged more than 20 years, less than 45 years at the time of giving informed consent.
2) A person of Japanese nationality for 20 years.
3) A person who, during the screening period, is not using chronic or seasonal drugs or medical equipment, and is not undergoing rehabilitation therapy.
4) A person who has freely given consent and has understood the purpose of the study.
5) BMI:18.5 -30.0
6) Blood pressure
Systolic blood pressure : less than 159mmHg
Diastolic blood pressure : less than 99mmHg
7) Pulse rate
50-100 times/minute
8) Body temperature
35.5-37.0 degrees
9) Excessive exercise can prevent a person from participating in the clinical study.
10) Excessive eating can prevent a person from participating in the clinical study.
11) Women of childbearing ages who consent avoidance of the pregnancy during the clinical study.
12) Participant who understands that clinical visits are mandatory during clinical study period.
13) A person who are considered fit for the enrollment in the clinical study.
Key exclusion criteria
The following exclusion criteria apply to subjects.
1) Use of any prescription drugs or any over-the-counter drugs from -7 day to -1 day before dosing.
2) A person with diseases of the digestive tract, liver, kidney, heart, and circulatory system that might affect test food absorption, distribution, metabolism, and excretion.
3) A person with a lengthy surgical history, including gastrointestinal suture surgery, or intestinal resection. However, polypectomy and appendectomy will not exclude a patient.
4) A person with a history of cerebrovascular disease (asymptomatic lacunar infarction is excluded).
5) A person with tattoo.
6) A person with hypersensitivity or idiosyncrasy, such as food allergies.
7) A person with alcohol or drug dependency.
8) A person who has participated in other clinical trials within 84 days of giving informed consent.
9) A person who has donated 400 ml of blood within 84 days, 200 ml of blood within 28 days, or a blood component (plasma or platelets) within 14 days of giving informed consent.
10) A person trying to become pregnant within the clinical study period.
11) Unable or unwilling to use medically acceptable means of contraception.
12) Nursing or pregnant woman.
13) A person whose diagnosis requires treatment of mental illness by a clinical investigator.
14) A person who is unable to comply with administrative matters during the clinical study.
15) Other people, who are determined ineligible by the clinical investigator.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hitoshi Yoshida |
Organization
MEDOC Medical Dock&Clinic
Division name
Internal medicine
Zip code
Address
4-3, Yasudadori, Syowa-ku, Nagoya, Aichi, 466-0857, Japan
TEL
052-752-1135
chiken@medoc.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromichi Hayashi |
Organization
Medical Fusion Co.,Ltd.
Division name
Clinical development division
Zip code
Address
Nagoya Life Science Incubator, 2-22-8, Chikusa, Chikusa-ku, Nagoya, Aichi, 464-0858, Japan
TEL
052-745-3300
Homepage URL
http://www.m-fusion.co.jp/
info@m-fusion.co.jp
Sponsor or person
Institute
Medical Fusion Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
Eminet Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 10 | Month | 02 | 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
| 2015 | Year | 09 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 19 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2016 | Year | 09 | Month | 08 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 30 | 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=R000022154
