UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026277 |
|---|---|
| Receipt number | R000030178 |
| Scientific 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 |
| Date of disclosure of the study information | 2017/02/25 |
| Last modified on | 2017/02/23 14:44:28 |
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Basic information
Public 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
Acronym
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
Scientific 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
Scientific Title:Acronym
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
| 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
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
ishii@dr-wellness.co.jp
Sponsor or person
Institute
Kojinkai Medical Corporation Shin-Nihonbashi Ishii clinic
Institute
Department
Personal name
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
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 |
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 | 12 | Month | 08 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030178
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