UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020607
Receipt number R000023788
Scientific Title Efficacy and long-term safety trials - Double-blind, placebo-controlled, dose-response, parallel-group study using a test food "EMFCTR-01" of the usual dose or the triple dose -
Date of disclosure of the study information 2016/01/18
Last modified on 2017/09/08 16:14:15

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Basic information

Public title

Efficacy and long-term safety trials
- Double-blind, placebo-controlled, dose-response, parallel-group study using a test food "EMFCTR-01" of the usual dose or the triple dose -

Acronym

Efficacy and long-term safety trials
- Double-blind, placebo-controlled, dose-response, parallel-group study using a test food "EMFCTR-01" of the usual dose or the triple dose -

Scientific Title

Efficacy and long-term safety trials
- Double-blind, placebo-controlled, dose-response, parallel-group study using a test food "EMFCTR-01" of the usual dose or the triple dose -

Scientific Title:Acronym

Efficacy and long-term safety trials
- Double-blind, placebo-controlled, dose-response, parallel-group study using a test food "EMFCTR-01" of the usual dose or the triple dose -

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 or 3times-dose "EMFCTR-01" for 12 weeks.
We evaluated safety through physical examinations (interviews, auscultation, percussion, inspection, palpation, etc.), changes in clinical laboratory values, and diary by subject from the baseline evaluation (vist0) to the third evaluation (visit3) or post evaluation.

Basic objectives2

Others

Basic objectives -Others

We evaluated Efficacy of the test food "EMFCTR-01" through the fecal status from the next day after obtaining informed consent to Visit3. Also, we verified the effects of "EMFCTR-01" on other parameters, including organ functionality, through, physical examinations (interview, auscultation, percussion, inspection, palpation, etc.), and changes in clinical laboratory values from the baseline evaluation (visit0) to the third evaluation (visit3) or post evaluation.

Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Adverse events
period : from Visit0 to Visit3

Key secondary outcomes

-Physical signs, physical symptom, primary disease, complications, anamnesis, history of present illness
-Concomitant medications, adjunctive therapy
-Blood pressure/pulse
-Body temperature
-Height, Weight, Body mass index(BMI)
-12-lead electrocardiogram
-General hematology tests
-Blood biochemistry tests
-Urinalysis -The fecal situation (fecal frequency, fecal volume , fecal property)
-Meal recording
-State of facial skin as examined by Robo Skin Analyzer RSA50.
-State of hair as examined by Mobile Skin Analyzer AOT-ST.
-Blood pressure pulse wave
-Hardness of muscle
-CT examination


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment

Numbered container method


Intervention

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

dosing period : 12 weeks
dose : usual dose ("EMFCTR-01"concentration 11mL/33mL)
frequency : once a day

Interventions/Control_2

dosing period : 12 weeks
dose : 3 times dose 33mL ("EMFCTR-01"concentration 33mL/33mL)
frequency : once a day

Interventions/Control_3

dosing period : 12 weeks
dose : plasebo 33mL ("EMFCTR-01"concentration 0mL/33mL)
frequency : once a day

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

30 years-old <=

Age-upper limit

55 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 30 years, less than 55 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.
-A person whom the tendency of the property of the feces(the score of the property of the feces/days) is less than 2.5 from the next day of the agreement acquisition day to -1 day.
-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 prescription drugs or any over-the-counter 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 housemate is participating or a plan to participate in this clinical study.
-A person with taking "tenshi no Lara" within the past for 1 year from an agreement acquisition day.
-A women who is postmenopausal
-A person who are engaged in night duty.
-The person doing the hair dyeing, the permanent wave and the frizzled hair correction, etc. which have an influence on a hair and scalp.
-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

45


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 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


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 22 Day

Last follow-up date

2016 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2016 Year 12 Month 27 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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023788


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name