UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055482 |
|---|---|
| Receipt number | R000063394 |
| Scientific Title | The placebo-controlled parallel-group comparison trial to study the effects of supplement intake on hair zinc and testosterone levels |
| Date of disclosure of the study information | 2024/10/03 |
| Last modified on | 2026/03/16 16:57:07 |
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Basic information
Public title
The study on the effects of supplement intake on hair zinc and testosterone levels
Acronym
The study on the effects of supplement intake on hair zinc and testosterone levels
Scientific Title
The placebo-controlled parallel-group comparison trial to study the effects of supplement intake on hair zinc and testosterone levels
Scientific Title:Acronym
The placebo-controlled parallel-group comparison trial to study the effects of supplement intake on hair zinc and testosterone levels
Region
| Japan |
Condition
Condition
healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of zinc supplement intake on hair zinc and testosterone levels
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Testosterone and zinc levels in hair
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Continuous intake of the test food(placebo, two tablets per day) for 12 weeks
Interventions/Control_2
Continuous intake of the test food(active, two tablets per day) for 12 weeks
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
| 50 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male
Key inclusion criteria
1)Japanese men aged 50 to 59 at the time of obtaining consent.
2)Those who can submit a total of 60 hair strands, with at least 20 strands each from the back, top, and sides of the head, cut from the root to about 1 cm, on 2 times: during screening and at the end of this study. The hair can be cut by themselves or by a family member.
3)Individuals with a BMI ranging from 18 to 29.9 (men).
Key exclusion criteria
1)Those who have had or plan to have a haircut, perm, grey hair dyeing, and coloring within 4 weeks prior to the screening date and the final observation date of this study (this is allowed if it occurs between the screening and 4 weeks prior to the final observation date).
2)Those who are currently undergoing treatment for depression or other psychiatric disorders.
3) Those who are currently undergoing treatment for adrenal dysfunction (e.g., those with collagen diseases and rheumatoid arthritis being treated with steroids).
4) Those who are undergoing treatment with oral and topical glucocorticoids (such as hydrocortisone esters and prednisolone).
5)Those who are undergoing treatment for thyroid disorders.
6)Those who are undergoing treatment for LOH (Late-Onset Hypogonadism) syndrome at medical institutions such as specialized clinics (including testosterone replacement therapy).
7)Those who have taken 5-alpha reductase inhibitors (medications for AGA) within the past 6 months.
8)Individuals taking supplements containing minerals (such as zinc and multiminerals).
9)Those who are using shampoos containing minerals (such as zinc and seaweed).
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Toshiki |
| Middle name | |
| Last name | Asano |
Organization
UHA Mikakuto Co.,Ltd.
Division name
Global Healthcare Research Laboratory
Zip code
540-0015
Address
5-2, Junikencho, Chuou-ku, Osaka-city, Osaka
TEL
06-6767-6050
asanot@uha-mikakuto.co.jp
Public contact
Name of contact person
| 1st name | Mami |
| Middle name | |
| Last name | Kishida |
Organization
UHA Mikakuto Co.,Ltd.
Division name
Global Healthcare Research Laboratory
Zip code
540-0015
Address
5-2, Junikencho, Chuou-ku, Osaka-city, Osaka
TEL
06-6767-6050
Homepage URL
kisidam@uha-mikakuto.co.jp
Sponsor or person
Institute
UHA Mikakuto Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
UHA Mikakuto Co.,Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board of Shiba Palace Clinic
Address
1-9-10, Hamamatsu-cho, Minato-ku, Tokyo
Tel
03-5408-1599
shiba_palace@s-palace-clinic.com
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
| 2024 | Year | 10 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
43
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
Completed
Date of protocol fixation
| 2024 | Year | 08 | Month | 27 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will perform within-group pre- and post-comparisons as needed.
Management information
Registered date
| 2024 | Year | 09 | Month | 11 | Day |
Last modified on
| 2026 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063394
