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 desig
Not Applicable
- Conditions
- Healthy adults
- Registration Number
- JPRN-UMIN000023687
- Lead Sponsor
- Kojinkai Medical Corporation Shin-Nihonbashi Ishii clinic
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the amount of change in max-IMT from baseline after taking collagen for 12 weeks with collagen placebo group
- Secondary Outcome Measures
Name Time Method 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