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

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 - 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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000026277

Enrollment

120

Registered

2017-02-25

Start date

2017-02-27

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy adults and subjects with mild carotid artery hypertrophy

Interventions

-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 we

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
To compare the rate of change in max-IMT from baseline after taking collagen for 12 weeks with collagen placebo group	—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactHikaru Ishii

Kojinkai Medical Corporation Shin-Nihonbashi Ishii Clinic Director

ishii@dr-wellness.co.jp03-3662-5901

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026