UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Research on the effectiveness of collagen tripeptide that target arterial sclerosis
Title of the study (Brief title)	Research on the effectiveness of collagen tripeptide that target arterial sclerosis
Region	Japan

Condition
Condition	Arteriosclerosis
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The CTP was orally administered to arterial sclerosis patient, reveal the impact on the arteriosclerosis index.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1) blood lipid 2) ABI inspection 3) PWV inspection 4) carotid artery echo 5) liver function tests
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
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	6 months
Interventions/Control_2	Once a day, the CTP tablet 16 tablets orally taken with a glass of water or lukewarm water cup at dinner (can be any of the pre-meal, after a meal).
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. This study to understand, there is the ability to comply with it who 2. Prior to participation in the study, those who consent by the document can be obtained 3. Hyperlipidemia, or hypertension, or who have been diagnosed with both its
Key exclusion criteria	1.Those who study doctor was ineligible as an object of the present study 2. Those of type 1 or type 2 diabetes 3. A person suspected of cerebral infarction with paralysis Four. Acute coronary syndrome, unstable angina, acute myocardial infarction, a person with a history of acute cerebral infarction and transient ischemic attack Five. Patients with cancer 6. Hypothyroidism, the person suspected of Graves' disease 7. A person suspected of liver disease, including hepatitis virus persistent infection 8. Persons with renal disease severe 9. A person who has a liver disorder of severe 10. Who during pregnancy and lactation 11. Patient in hospital 12. It is under ingestion other health supplements, functional foods, those who can not stop eating during the test
Target sample size	100

Research contact person
Name of lead principal investigator	Takeshi Okada
Organization	Saiseikai Matsuyama Hospital
Division name	Internal medicine
Address	Matsuyama, Ehime Prefecture Shanxi-cho, 880-2
TEL	089-951-6111
Email	chiken@matsuyama.saiseikai.or.jp

Public contact
Name of contact person	Yoshiharu Shimizu
Organization	Saiseikai Matsuyama Hospital
Division name	Clinical trial management office
Address	Matsuyama, Ehime Prefecture Shanxi-cho, 880-2
TEL	089-951-6164
Homepage URL
Email	chiken@matsuyama.saiseikai.or.jp

Sponsor
Institute	Saiseikai Matsuyama Hospital
Institute
Department

Funding Source
Organization	Saiseikai Matsuyama Hospital
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	2016 Year 07 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 01 Day
Anticipated trial start date	2016 Year 07 Month 21 Day
Last follow-up date	2018 Year 08 Month 31 Day
Date of closure to data entry	2018 Year 12 Month 31 Day
Date trial data considered complete	2018 Year 12 Month 31 Day
Date analysis concluded	2019 Year 12 Month 31 Day

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

Management information
Registered date	2016 Year 07 Month 15 Day
Last modified on	2019 Year 01 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026728