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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000023687
Receipt No. R000027225
Scientific Title Clinical trial to investigate the efficacy of fish skin-derived collagen on wall thickness in the carotid artery and safety in healthy adults by a double-blind parallel group comparison design
Date of disclosure of the study information 2016/08/19
Last modified on 2016/08/16

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Basic information
Public title Clinical trial to investigate the efficacy of fish skin-derived collagen on wall thickness in the carotid artery and safety in healthy adults by a double-blind parallel group comparison design
Acronym Clinical trial to investigate the efficacy of fish skin-derived collagen on wall thickness in the carotid artery and safety in healthy adults by a double-blind parallel group comparison design
Scientific Title Clinical trial to investigate the efficacy of fish skin-derived collagen on wall thickness in the carotid artery and safety in healthy adults by a double-blind parallel group comparison design
Scientific Title:Acronym Clinical trial to investigate the efficacy of fish skin-derived collagen on wall thickness in the carotid artery and safety in healthy adults by a double-blind parallel group comparison design
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
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
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To compare the amount 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
-ABI : Ankle Brachial Index
-CAVI : Cardio-Ankle Vascular Index
-High-Sensitivity C-Reactive Protein

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
50 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria -Subjects aged 50 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 1.5 to 2.5mm
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
1st name
Middle name
Last name Hikaru Ishii
Organization Kojinkai Medical Corporation Shin-Nihonbashi Ishii Clinic
Division name Director
Zip code
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
1st name
Middle name
Last name Hikaru Ishii
Organization Kojinkai Medical Corporation Shin-Nihonbashi Ishii Clinic
Division name Director
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 08 Month 19 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2016 Year 07 Month 19 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 08 Month 19 Day
Last modified on
2016 Year 08 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027225

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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