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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020608
Receipt No. R000023789
Scientific Title Long-term safety trial - Non-blinded safety verification test using a dose of the test food "FGPPY30" five times higher than that intended for healthy individuals -
Date of disclosure of the study information 2016/01/18
Last modified on 2017/09/08

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Basic information
Public title Long-term safety trial
- Non-blinded safety verification test using a dose of the test food "FGPPY30" five times higher than that intended for healthy individuals -
Acronym Long-term safety trial
- Non-blinded safety verification test using a dose of the test food "FGPPY30" five times higher than that intended for healthy individuals -
Scientific Title Long-term safety trial
- Non-blinded safety verification test using a dose of the test food "FGPPY30" five times higher than that intended for healthy individuals -
Scientific Title:Acronym Long-term safety trial
- Non-blinded safety verification test using a dose of the test food "FGPPY30" 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 "FGPPY30" 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 "FGPPY30" on other parameters, including organ functionality, through, physical examinations (interview, auscultation, percussion, inspection, palpation, etc.), antioxidant, oxidative stress, adiponectin and changes in clinical laboratory values from the baseline evaluation (visit0) to the second evaluation (visit2) or post evaluation.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Confirmation of adverse events
Key secondary outcomes -Physical signs, physical symptom, primary disease, complications, anamnesis, history of present illness
-Concomitant medications, adjunctive therapy
-Body temperature
-Blood pressure/pulse
-Height, weight,Body mass index(BMI)
-12-lead electrocardiogram
-General hematology tests
-Blood biochemistry tests
-Antioxidants, oxidative stress and adiponectin
-Urinalysis
-The fecal situation (fecal frequency, fecal volume , fecal property)
-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 daily take 5 times dose
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.
-Healthy Japanese men and women aged more than 20 years, less than 45 years at the time of giving informed consent.
-A person of Japanese nationality for 20 years.
-A person who, during the screening period, is not using chronic or seasonal drugs or medical equipment, and is not undergoing rehabilitation therapy.
-A person who has freely given consent and has understood the purpose of the study.
-BMI:18.5 - 30.0
-Blood pressure
Systolic blood pressure:less than 159mmHg
Diastolic blood pressure:less than 99mmHg
-Pulse rate: 50-100 times/minute
-Body temperature: 35.5-37.0 degrees
-Excessive exercise can prevent a person from participating in the clinical study.
-A person who can take three meals a day basically and prohibit great intemperance during the clinical study.
-A person who can conduct contraception by an appropriate way during the clinical study.
-Participant who understands that clinical visits are mandatory during clinical study period.
-A person who are considered fit for the enrollment in the clinical study.
Key exclusion criteria The following exclusion criteria apply to subjects.
-Use of any drugs from -7 day to -1 day before dosing.
-A person who have used the steroid drug within the past three months of consent acquisition date.
-A person with diseases of the digestive tract, liver, kidney, heart, and circulatory system that might affect test food absorption, distribution, metabolism, and excretion.
-A person with a lengthy surgical history, including gastrointestinal suture surgery, or intestinal resection. However, polypectomy and appendectomy will not exclude a patient.
-A person with a history of cerebrovascular disease (asymptomatic lacunar infarction is excluded).
-A person with tattoo.
-A person with hypersensitivity or idiosyncrasy, such as food allergies.
-A person with alcohol or drug dependency.
-A person who has participated in other clinical trials within 84 days of giving informed consent.
-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.
-The person who hopes for pregnancy or the person who can't prevent conception during the clinical study.
-Nursing or pregnant woman.
-A person whose diagnosis requires treatment of mental illness by a clinical investigator.
-A person who are engaged in night duty.
-A person who is unable to comply with administrative matters during the clinical study.
-A person 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
Email 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/
Email info@m-fusion.co.jp

Sponsor
Institute Medical Fusion Co.,Ltd.
Institute
Department

Funding Source
Organization Sun- O International 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
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

Other administrative information
Date of disclosure of the study information
2016 Year 01 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
2016 Year 01 Month 07 Day
Date of IRB
Anticipated trial start date
2016 Year 02 Month 29 Day
Last follow-up date
2016 Year 06 Month 11 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
2016 Year 01 Month 17 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=R000023789

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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