UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059778 |
|---|---|
| Receipt number | R000068226 |
| Scientific Title | Observational Study on Hair Follicle Cells and Gut Health in Healthy Adult Males |
| Date of disclosure of the study information | 2025/11/16 |
| Last modified on | 2025/11/05 16:52:12 |
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Basic information
Public title
Observational Study on Hair Follicle Cells and Gut Health in Healthy Adult Males
Acronym
Observational Study on Hair Follicle Cells and Gut Health in Healthy Adult Males
Scientific Title
Observational Study on Hair Follicle Cells and Gut Health in Healthy Adult Males
Scientific Title:Acronym
Observational Study on Hair Follicle Cells and Gut Health in Healthy Adult Males
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
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
Basic objectives -Others
Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Height/Weight/Body Fat Percentage/BMI
2) Blood-based analysis
3) Urine-based analysis
4) Saliva-based analysis
5) Oral mucosa-based analysis
6) Fecal sample-based analysis
7) Heart sounds, bowel sounds measurement
8) GSRS questionnaire (Gastrointestinal Symptom Rating Scale)
9) Simple Stress Level Checklist (Nihon University Katsura/Murakami version)
10) OSA Sleep Questionnaire MA Version
11) Hair analysis
12) Medical interview by physician
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 70 | 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 sample size
51
Research contact person
Name of lead principal investigator
| 1st name | Tatsuhiko |
| Middle name | |
| Last name | Hirota |
Organization
Asahi Quality & Innovations, Ltd.
Division name
Core Technology Research Institute
Zip code
302-0106
Address
1-21,Midori 1-chome,Moriya-shi,Ibaraki,302-0106
TEL
0297-46-4064
tatsuhiko.hirota@asahi-qi.co.jp
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings Co., Ltd.
Division name
Administrative Department of Clinical Trials
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Asahi Quality & Innovations, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
+81-3-6240-1162
jimukyoku@tes-h.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Measurement of hair root cells, analysis of hair root cell health status, health indicator analysis using blood, urine, saliva, oral mucosa, and fecal samples, measurement of heart sounds and bowel sounds, and observational studies based on various questionnaire surveys.
Management information
Registered date
| 2025 | Year | 11 | Month | 14 | Day |
Last modified on
| 2025 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068226
