UMIN-CTR Clinical Trial

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
Email	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
Email	yasuyo.suga.nj7@asv.ajinomoto.com

Sponsor
Institute	SOUKEN Co., Ltd.
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053223