UMIN-CTR Clinical Trial

Basic information
Public title	The effects of food ingestion on hair
Acronym	The effects of food ingestion on hair
Scientific Title	The effects of food ingestion on hair
Scientific Title:Acronym	The effects of food ingestion on hair
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effects of food ingestion on hair
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Hair diameter of the top of the head Hair diameter of the side of the head
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	60 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Healthy person from 20 to 60 years of age (2) Healthy person who eat test food amount of regulation and over or less than in a day (3) Subjects giving written informed consent
Key exclusion criteria	(1) Individuals having symptoms that hair-related (2) Individuals taking supplement or medications that effect hair (3) Individuals who have the of pregnancy
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Kenji Middle name Last name Osawa
Organization	Lotte Co., Ltd.
Division name	Central Laboratory, Kamukoto Research Department
Zip code	336-8601
Address	1-1, Numakage-3chome, Minami-ku, Saitama
TEL	048-837-0744
Email	oosawa_kenji@lotte.co.jp

Public contact
Name of contact person	1st name Naoya Middle name Last name Oshima
Organization	Lotte Co., Ltd.
Division name	Central Laboratory, Kamukoto Research Department
Zip code	336-8601
Address	1-1, Numakage-3chome, Minami-ku, Saitama
TEL	048-837-0744
Homepage URL
Email	ooshima_naoya@lotte.co.jp

Sponsor
Institute	Lotte Co., Ltd.
Institute
Department

Funding Source
Organization	Lotte 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	Shiba Palace Clinic
Address	6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
Tel	03-5408-1590
Email	jimukyoku@mail.souken-r.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	2020 Year 03 Month 18 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	Completed
Date of protocol fixation	2020 Year 03 Month 12 Day
Date of IRB	2020 Year 03 Month 12 Day
Anticipated trial start date	2020 Year 03 Month 19 Day
Last follow-up date	2020 Year 07 Month 23 Day
Date of closure to data entry	2020 Year 07 Month 30 Day
Date trial data considered complete	2020 Year 07 Month 30 Day
Date analysis concluded	2020 Year 08 Month 27 Day

Other
Other related information	Study design cohort design Way for subscription Everyone who exchanged the selection criteria in March-July 2020

Management information
Registered date	2020 Year 03 Month 18 Day
Last modified on	2020 Year 09 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045461