UMIN-CTR Clinical Trial

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

Healthy person

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Medical Fusion Co.,Ltd.

Institute

Department

Personal name

Organization

Sun- O International Co., Ltd

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

01

Month

18

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2016

Year

01

Month

17

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=R000023789