UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A clinical study for evaluating efficacy and safety of long-term consumption -Double-blind, placebo-controlled parallel-group comparative, efficacy and safety of long-term verification study taking 1 times the dose of test food mainly composed of "ECM-E" that is an extract of chicken crests containing hyaluronic acid.
Title of the study (Brief title)	A clinical study for evaluating efficacy and safety of long-term consumption -Double-blind, placebo-controlled parallel-group comparative, efficacy and safety of long-term verification study taking 1 times the dose of test food mainly composed of "ECM-E" that is an extract of chicken crests containing hyaluronic acid.
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We verify the efficacy and safety of long-term consumption of "ECM-E" for 12 weeks (by taking its normal dose).
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	-State of facial skin -Appearance of adverse events (period : from Visit0 to Visit3)
Key secondary outcomes	-State of elbow skin -Intensity of menstrual pain by verbal rating scale -Height, weight and BMI -Body temperature, blood pressure and pulse -12-lead electrocardiogram -General hematology test -Blood biochemistry test -Urinalysis

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	Daily intake normal dose of test food "ECM-E-A" for 84 days
Interventions/Control_2	Daily intake normal dose of test food "ECM-E-B" for 84 days
Interventions/Control_3	Daily intake normal dose of plasebo for 84 days
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	59 years-old >=
Gender	Male and Female
Key inclusion criteria	Target subject must satisfy the following selection criteria. 1) Healthy Japanese aged from 20 to 59 years-old at the time of giving informed consent 2) A person who are conscious of dullness or dryness of skin 3) A person who is not using chronic or seasonal drugs or medical equipment and is not undergoing rehabilitation therapy 4) A person who has freely given informed consent and has fully understood the purpose of the study 5) A person whose BMI is from 18.5 to 30.0 6) 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 7) A person whose pulse rate is from 40 to 100 per minute 8) A person whose body temperature is from 35.5 to 37.0 degree Celsius 9) A person who can prevent from excessive exercise during the study 10) A person who can basically have 3 meals in a day during the study 11) A person who can conduct contraception by appropriate ways during the study 12) A person who understands and follows rules and requirements during the study 13) 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 nursing or pregnant woman 10) A person who is engaged in night duty 11) A person who has taken foods mainly composed of "ECM-E" within 28 days from the day that he/she gave an informed consent
Target sample size	45

Research contact person
Name of lead principal investigator	Akihito Yoshida
Organization	MEDOC Medical Dock & Clinic
Division name	internal medicine
Address	4-3, Yasudadori, Showa-ku, Nagoya-shi, Aichi, 466-0857, Japan
TEL	052-752-1135
Email	chiken@medoc.jp

Public contact
Name of contact person	Hiromichi Hayashi
Organization	Medeical Fusion Co.,Ltd.
Division name	Clinical development division
Address	Nagoya Life Science Incubator, 2-22-8, Chikusa, Chikusa-ku, Nagoya-shi, Aichi, 464-0858, Japan
TEL	052-745-3300
Homepage URL	http://www.m-fusion.co.jp/
Email	info@m-fusion.co.jp

Sponsor
Institute	Adaptgen Pharmaceutical Co., Ltd.
Institute
Department

Funding Source
Organization	Adaptgen Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 03 Month 29 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 03 Month 06 Day
Anticipated trial start date	2017 Year 03 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete	2018 Year 05 Month 02 Day
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results	http://adaptgen.co.jp/
Results
Other related information

Management information
Registered date	2017 Year 03 Month 15 Day
Last modified on	2018 Year 06 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030504