UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical trial to investigate the efficacy and safety of fish skin-derived collagen on wall thickness in the carotid artery and clinical symptom, etc. in healthy adults and subjects with mild carotid artery hypertrophy by a double-blind parallel group comparison design
Title of the study (Brief title)	Clinical trial to investigate the efficacy and safety of fish skin-derived collagen on wall thickness in the carotid artery and clinical symptom, etc. in healthy adults and subjects with mild carotid artery hypertrophy by a double-blind parallel group comparison design
Region	Japan

Condition
Condition	Healthy adults and subjects with mild carotid artery hypertrophy
Classification by specialty	Medicine in general Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy on IMT, Intima media-thickness, and safety of fish skin-derived collagen intake in healthy adults and subjects with mild carotid artery hypertrophy and to investigate the improvement of symptoms of chill of the whole body and constipation.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	To compare the rate of change in max-IMT from baseline after taking collagen for 12 weeks with collagen placebo group
Key secondary outcomes	To compare the amount of change in following items from baseline after taking collagen for 12 weeks with collagen placebo group -max-IMT -ABI : Ankle Brachial Index -CAVI : Cardio-Ankle Vascular Index -High-Sensitivity C-Reactive Protein -Chill -Constipation -Velocity of blood flow and blood vessel thickness at capillary of the nail -Blood pressure

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	-Collagen group: Three packs of jelly containing 2.5g fish skin-derived collagen will be administered at least 30 minutes before breakfast with one 1000mg-tablet of Vitamin C. -Duration time : 12 weeks
Interventions/Control_2	-Collagen placebo group: Three packs of placebo jelly will be administered at least 30 minutes before breakfast with one 1000mg-tablet of Vitamin C. -Duration time : 12 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	40 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	-Subjects aged 40 years or older at the time of obtaining informed consent -Healthy adults men and women -Body mass index between 18.5 to 25 kg/m2 -max-IMT, Maximum Intima media-thickness, between 0.70 to 2.50mm Then, it is classified into the following two groups by max-IMT. Healthy adults : max-IMT, between 0.70 mm to 1.09mm 80 subjects Subjects with mild carotid artery hypertrophy : max-IMT, between 1.10 mm to 2.50 mm 40 subjects
Key exclusion criteria	-Subjects who participated in any clinical trial within 4 months prior to administrating study foods. -Subjects who had been taking supplements or Foods for Specified Health Uses mainly composed of collagen or placenta within 6 months prior to administrating study foods, and subjects who have ever taken Natural Marin Collagen Jelly (even once). -Employees and family of implementation medical institution -Pregnant or nursing women -Subjects with low potential to comply with the study protocol and subjects who are otherwise judged by the principal investigator or sub-investigator to be inappropriate for inclusion in the study
Target sample size	120

Research contact person
Name of lead principal investigator	Hikaru Ishii
Organization	Kojinkai Medical Corporation Shin-Nihonbashi Ishii Clinic
Division name	Director
Address	Shin-Edobashi Bldg, 8-6, Kobuna-cho, Nihonbashi, Chuo-ku Tokyo, 103-0024, Japan
TEL	03-3662-5901
Email	ishii@dr-wellness.co.jp

Public contact
Name of contact person	Hikaru Ishii
Organization	Kojinkai Medical Corporation Shin-Nihonbashi Ishii Clinic
Division name	Director
Address	Shin-Edobashi Bldg, 8-6, Kobuna-cho, Nihonbashi, Chuo-ku Tokyo, 103-0024, Japan
TEL	03-3662-5901
Homepage URL
Email	ishii@dr-wellness.co.jp

Sponsor
Institute	Kojinkai Medical Corporation Shin-Nihonbashi Ishii clinic
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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

Other administrative information
Date of disclosure of the study information	2017 Year 02 Month 25 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 12 Month 08 Day
Anticipated trial start date	2017 Year 02 Month 27 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 02 Month 23 Day
Last modified on	2017 Year 02 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030178