UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046747 |
|---|---|
| Receipt number | R000053223 |
| Scientific Title | Evaluation of usefulness of food containing amino acids on hair and scalp: a randomized, placebo-controlled, double-blind study |
| Date of disclosure of the study information | 2022/02/01 |
| Last modified on | 2022/01/27 11:17:23 |
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Basic information
Public title
Evaluation of usefulness of food containing amino acids on hair and scalp
Acronym
Evaluation of usefulness of food containing amino acids on hair and scalp
Scientific Title
Evaluation of usefulness of food containing amino acids on hair and scalp: a randomized, placebo-controlled, double-blind study
Scientific Title:Acronym
Evaluation of usefulness of food containing amino acids on hair and scalp (RCT study)
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examines the effect of food containing amino acids on hair and scalp in healthy adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the number of hair loss (24 weeks)
moisture content of the scalp (24 weeks)
Key secondary outcomes
the number of hair loss (12 weeks)
moisture content of the scalp (12 weeks)
the number of hair, hair diameters, the situation of the whole hair, amount of sebum in the scalp, blood flow in the scalp, subjective symptoms (during that period)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved 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
Intake of food (active) once a day for 24 weeks
Interventions/Control_2
Intake of food (placebo) once a day for 24 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
| 20 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male
Key inclusion criteria
Japanese healthy male aged 20-64 years who is aware of thinning hair
Key exclusion criteria
1) subjects with skin diseases in their scalp
2) subjects who have been diagnosed with alopecia before
3) subjects who are going to the hospital and receiving treatment for diseases
4) subjects using medicines, supplements, or health foods
5) subjects using supplements containing amino acids
6) subjects who participate in other clinical trials, who have participated in other tests within one month of obtaining consent, who plan to participate in other trials during this trial
7) subjects have a lot of gray hair with undyed hair, those whose hair color has changed due to decoloration
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | Hirano |
Organization
Ajinomoto Co., Inc.
Division name
Institute of Food Sciences and Technologies
Zip code
210-8681
Address
1-1, Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa
TEL
080-7739-9340
tomoko.hirano.ri7@asv.ajinomoto.com
Public contact
Name of contact person
| 1st name | Yasuyo |
| Middle name | |
| Last name | Suga |
Organization
Ajinomoto Co., Inc.
Division name
Institute of Food Sciences and Technologies
Zip code
210-8681
Address
1-1, Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa
TEL
070-4325-5188
Homepage URL
yasuyo.suga.nj7@asv.ajinomoto.com
Sponsor or person
Institute
SOUKEN Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Ajinomoto Co., Inc.
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
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho 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
株式会社SOUKEN（東京都） / SOUKEN Co., Ltd. (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | Month | 01 | 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
| 2021 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 09 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 01 | Month | 27 | Day |
Last modified on
| 2022 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053223
