UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A clinical study for evaluating the safety of excessive intake of salmon nasal cartilage extract including proteoglycan
Title of the study (Brief title)	A clinical study for evaluating the safety of excessive intake of salmon nasal cartilage extract
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the safety of excessive intake of salmon nasal cartilage extract for 4 weeks in healthy adults.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Hematologic test Biochemistry test Urinalysis Medical interview Adverse event
Key secondary outcomes

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	Consumption of salmon nasal cartilage extract, 5 fold quantity of recommended daily intake, for 4 weeks.
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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Healthy men and women. 2) Subjects giving written informed consent based on Declaration of Helsinki. 3) Subjects who can intake test food sample every day during test period. 4) Subjects who can attend to every examinations.
Key exclusion criteria	1) Subjects who take drugs or supplements 2) Subjects undergoing treatment for some serious disorders 3) Subjects who make a blood donation within the last month before and during the test 4) Women who are pregnant or breast-feeding 5) Subjects who have allergies to salmon, shrimp or crab 6) Subjects whose participation is deemed inappropriate by pilot questionnaire, clinical test values or physical exam values 7) Subjects who cannot follow a guideline of test 8) Subjects undergoing hormone replacement therapy 9) Subjects whose participation is deemed inappropriate by a test director
Target sample size	20

Research contact person
Name of lead principal investigator	Kazue Takayama
Organization	Ichimaru Pharcos Co., Ltd.
Division name	Product Development
Address	318-1 Asagi, Motosu-Shi, Gifu 501-0475 Japan
TEL	058-320-1036
Email	takayama-kazue@ichimaru.co.jp

Public contact
Name of contact person	Kazunori Enya
Organization	Ichimaru Pharcos Co., Ltd.
Division name	Product Development
Address	318-1 Asagi, Motosu-Shi, Gifu 501-0475 Japan
TEL	058-320-1037
Homepage URL
Email	enya-kazunori@ichimaru.co.jp

Sponsor
Institute	Ichimaru Pharcos Co., Ltd.
Institute
Department

Funding Source
Organization	Ichimaru Pharcos Co., Ltd.
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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	独立行政法人地域医療機能推進機構 可児とうのう病院　健康管理センター

Other administrative information
Date of disclosure of the study information	2017 Year 06 Month 13 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 06 Day
Anticipated trial start date	2015 Year 07 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 06 Month 12 Day
Last modified on	2017 Year 06 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031763