Tokyo, June 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062000) titled 'A verification study of effects of consumption of the test food on hair growth or hair' on June 22.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - API Co., Ltd.
Condition:
Condition - Healthy Japanese
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To verify the effects of consumption of the test food on hair growth or hair.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Duration: 12 weeks
Test product: Test food
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1. Japanese
2. Men or women
3. Adults
4. Healthy individuals
Key exclusion criteria - Individuals (who / whose)
1. are receiving treatment for or have a history of malignant tumors, heart failure, or myocardial infarction
2. have an implanted pacemaker or implantable cardioverter defibrillator
3. are currently undergoing treatment for any of the following chronic diseases:
cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. have a past or current medical history of atopic dermatitis, who have bronchial asthma, conjunctivitis, or atopic dermatitis, or whose family members have any of these diseases
5. may develop allergic rhinitis or who plan to take medication for symptom relief during this study
6. have any symptoms (e.g., diseases such as urticaria, inflammation, eczema, external wound, acne, boil, wart, or traces of them) on the skin at evaluation sites (face or cephalon) that may influence the results of this study
7. have undergone or plan to undergo any special procedures (such as hair transplantation or hair extension) within the last four weeks or during this study
8. shaving of their head will interfere with their daily life
9. cannot collect hair due to short hair such as shaved hair
10. uric acid level is 7.0 mg/dL or more
11. have a medical history of drug or alcohol dependence
12. consume Foods for Specified Health Uses or Foods with Functional Claims
13. are taking or using medications (including herbal medicines) or supplements
14. are allergic to medications and foods related to the test product, particularly those allergic to salmon
15. are pregnant, lactating, or planning pregnancy during this study
16. are deemed unsuitable for participation in this study by the principal investigator
Target Size - 20
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2026 Year 06 Month 10 Day
Date of IRB - 2026 Year 06 Month 10 Day
Anticipated trial start date - 2026 Year 06 Month 22 Day
Last follow-up date - 2026 Year 11 Month 20 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070946
Disclaimer: Curated by HT Syndication.