Tokyo, Jan. 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060289) titled 'Verification of the effects of ingesting salmon nasal cartilage components on the skin' on Jan. 8.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Kansai Electric Power Medical Research Institute
Condition:
Condition - Adult men and women
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To verify the effectiveness of proteoglycan intake in preventing and improving skin fragility
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Participants will take one packet of proteoglycan-containing food (10 mg, Ichimaru Pharcos Co., Ltd.) between meals (between breakfast and lunch, lunch and dinner, or dinner and before bedtime) for 12 weeks. Primary and secondary endpoints will be measured at baseline, 4 weeks, 8 weeks, 12 weeks, and 20 weeks.
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - (1) Adult males and females
(2) Subjects who can be evaluated at the start of the study and at weeks 4, 8, 12, and 20
Key exclusion criteria - (1) Subjects with skin disorders currently using topical medications (including moisturizers) on the measurement area.
(2) Subjects currently using steroids.
(3) Subjects with severe liver or renal dysfunction.
(4) Subjects with heart failure (NYHA classification II or higher) that limits physical activity.
(5) Subjects with severe infections, serious injuries, or arthritis.
(6) Subjects with a salmon allergy.
(7) Subjects currently or within the past three months have been taking functional foods, health foods, or supplements that claim to improve skin health.
(8) Subjects with a history of cosmetic procedures or treatments on the measurement area within the past six months.
(9) Subjects deemed inappropriate for this clinical study by the attending physician or principal investigator.
Target Size - 20
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 12 Month 12 Day
Date of IRB - 2025 Year 12 Month 12 Day
Anticipated trial start date - 2026 Year 02 Month 02 Day
Last follow-up date - 2026 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068935
Disclaimer: Curated by HT Syndication.