Tokyo, Nov. 17 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059778) titled 'Observational Study on Hair Follicle Cells and Gut Health in Healthy Adult Males' on Nov. 16.
Study Type:
Observational
Primary Sponsor:
Institute - TES Holdings Co., Ltd.
Condition:
Condition - No
Classification by malignancy - Others
Genomic information - YES
Objective:
Narrative objectives1 - This study aims to conduct an observational study targeting healthy males aged 20 to 69 years. The study will measure hair follicle cells, analyze their health status, perform health indicator analysis using blood, urine, saliva, oral mucosa, and fecal samples, measure heart sounds and bowel sounds, and conduct various questionnaire surveys.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 20
years-old
Gender - Male
Key inclusion criteria - 1) Males aged 20 years or older but under 70 years at the time of obtaining consent to participate in the study
2) Individuals who are healthy and have no chronic physical disease including skin disease.
3) Individuals with normal hair volume and no hair loss on the frontal and parietal areas.
4) Individuals whose written informed consent has been obtained.
5) Individuals judged appropriate for the study by the principal.
Key exclusion criteria - 1) Individuals using medical products.
2) Individuals with symptoms such as thinning hair or alopecia.
3) Individuals with skin symptoms such as skin hypersensitivity, atopic dermatitis, seborrheic or dermatitis on the scalp.
4) Individuals with diseases such as liver, kidney, heart, lung, blood, digestive organ disorders, mental disorders, or severe anemia. Also, individuals with a history of serious medical conditions.
5) Individuals who have taken medications, including antibiotics, within the past month.
6) Individuals who have regularly used or are currently using hair growth agents, drugs, quasi-drugs, or health foods that promote hair growth within the past 3 months.
7) Individuals who are undergoing treatment or treatment related to hair growth.
8) Individuals whose BMI is over 25 kg/m2.
9) Individuals whose average weekly pure alcohol consumption exceeds 40 g/day for men.
10) Individuals who participated in other clinical studies in the past 3 months.
11) Individuals who are or whose family is engaged in functional foods or cosmetics.
12) Individuals judged inappropriate for the study by the principal.
Target Size - 51
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 10 Month 28 Day
Date of IRB - 2025 Year 10 Month 30 Day
Anticipated trial start date - 2025 Year 12 Month 02 Day
Last follow-up date - 2025 Year 12 Month 23 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068226
Disclaimer: Curated by HT Syndication.
