UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety evaluation of execessive consumption of proteoglycan complex 80 from salmon nasal cartilage - a randomized, double blind, placebo-controlled study -
Title of the study (Brief title)	Safety evaluation of execessive consumption of proteoglycan complex 80 from salmon nasal cartilage
Region	Japan

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

Objectives
Narrative objectives1	To investigate the safety of excessive consumption of proteoglycan complex 80 for 4 weeks
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Bloodchemistry, hematology and urine analysis at 2-week, 4-week consumption and 2-week after consumption period
Key secondary outcomes

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Ingestion of supplement containing proteoglycan complex 80 for 4 weeks
Interventions/Control_2	Ingestion of placebo without proteoglycan complex 80 for 4 weeks
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 male and female age 20 to 65 inclusive at the time of informed consent, BMI >30 inclusive. 2.Subjects who received an enough explanation of the test objectives and detail, who have consent ability, who are willing to participate with well understandings and who have signed the informed consent document.
Key exclusion criteria	1.Subjects who have been continuously treated by medicine. 2.Subjects who have a history of renal, hepatic, cardiac, respiratory, endocrine, or other metabolic disease or who have been treated for those diseases. 3.Subjects who have been regularly used medicine (Including antiflatulent and laxative) 4.Subjects who cannot stop taking supplement/health food (Including Special Health Food, Foods with "Function Claims") 5.Subjects who declared having an allergy for component of test tablet 6.Subjects who have a past surgical history or a history of digestive disease which affects digestion. 7.Subjects who are pregnant, willing to be pregnant or breast feeding. 8.Subjects with a history of drug dependence or alcohol dependence or past history of drug dependence or alcohol dependence 9.Subjects who made a blood component donation or whole blood donation more than 200mL within 4 weeks before the test starts 10.Subjects who have shift work or night shift work. 11.Subjects who have been participated in any other food or medicine intake clinical trial, cosmetic and medicine application trial or participated in any other clinical trial within 1 month after consent obtain, or who is willing to participate. 12.Any who is judged as unsuitable to participate in this clinical trial through by principal investigator or sub-investigator.
Target sample size	30

Research contact person
Name of lead principal investigator	Yasuo Kobuna
Organization	Kobuna orthopedic surgery
Division name	Medical office
Address	311-2, Gokanmachi, Maebashi, Gunma
TEL	027-261-7600
Email	info@kobunaseikei.jp

Public contact
Name of contact person	Yoshika Komori
Organization	KSO Corporation
Division name	Sales department
Address	1-9-7 Shibaura, Minato-ku, Tokyo
TEL	03-3452-7733
Homepage URL
Email	yoshi@kso.co.jp

Sponsor
Institute	KSO Corporation
Institute
Department

Funding Source
Organization	Nihon Pharmaceutical
Organization
Division
Category of Funding Organization	Profit organization
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

Other administrative information
Date of disclosure of the study information	2017 Year 06 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 02 Month 14 Day
Anticipated trial start date	2017 Year 03 Month 06 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 03 Month 03 Day
Last modified on	2017 Year 03 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030300