UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The pilot study on the effect of improving the arteriosclerosis index,blood lipid metabolism, coagulation and fibrinolysis by oral ingestion of collagen tripeptide.
Title of the study (Brief title)	The pilot study on the effect of improving the arteriosclerosis index,blood lipid metabolism, coagulation and fibrinolysis by oral ingestion of collagen tripeptide.
Region	Japan

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

Objectives
Narrative objectives1	Examination of effect of improving the indicators of arteriosclerosis by intake of collagen tripeptide in healthy people. 1. Reduction of lipid laboratory values. 2. Improvement of coagulation and fibrinolysis. 3. Improvement of arteriosclerosis index.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	FMD,CAVI
Key secondary outcomes	Total-cholesterol,HDL-cholesterol,LDL-cholesterol,TG FDP,D-D dimer

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	CTP-15(Collagen tripeptide) 16g/BID 6months
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	40 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Volunteer.(Men and women over the age of 40) 2. Person who are not taking EPA. 3. Person who can obtain the document consent.
Key exclusion criteria	1. Person with gelatin allergy. 2. Women who is pregnant,or breast-feeding,or planning to become pregnant. 3.Person who responsible investigator has determined that inappropriate.
Target sample size	30

Research contact person
Name of lead principal investigator	Naohisa Tomosugi
Organization	Kanazawa Medical University
Division name	Health Evaluation Center
Address	1-1 Daigaku,Utinada,Kahoku,Ishikawa
TEL	076-286-2211
Email	tomosugi@kanazawa-med.ac.jp

Public contact
Name of contact person	Masanori Aikawa
Organization	Kanazawa Medical University Hospital
Division name	Clinical Reseach and Trials Center
Address	1-1 Daigaku,Utinada,Kahoku,Ishikawa
TEL	076-218-8347
Homepage URL
Email	tiken@kanazawa-med.ac.jp

Sponsor
Institute	Kanazawa Medical University
Institute
Department

Funding Source
Organization	Kanazawa Medical University
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

Other administrative information
Date of disclosure of the study information	2015 Year 08 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 12 Month 28 Day
Anticipated trial start date	2013 Year 02 Month 01 Day
Last follow-up date	2016 Year 01 Month 31 Day
Date of closure to data entry	2016 Year 02 Month 12 Day
Date trial data considered complete	2016 Year 02 Month 12 Day
Date analysis concluded	2016 Year 09 Month 05 Day

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

Management information
Registered date	2015 Year 08 Month 03 Day
Last modified on	2016 Year 09 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021428