UMIN-CTR Clinical Trial

Basic information
Public title	Effects of a test food on skin conditons
Acronym	Effects of a test food on skin conditons
Scientific Title	Effects of a test food on skin conditons
Scientific Title:Acronym	Effects of a test food on skin conditons
Region	Japan

Condition
Condition	N/A(healthy adults)
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to examine effects of a test food for skin conditions.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Indexes for skin conditions (0, 8 weeks after ingestion)
Key secondary outcomes

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	Prevention
Type of intervention	Food
Interventions/Control_1	Oral ingestion of the test food for 8 weeks
Interventions/Control_2	Oral ingestion of the placebo food for 8 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	30 years-old <=
Age-upper limit	60 years-old >
Gender	Male and Female
Key inclusion criteria	1)Japanese individuals aged 30-59 years. 2)Individuals who are healthy without chronic physical illness, including skin diseases. 3)Individuals who are anxious about skin deterioration (dry or sagging skin, etc.) with aging. 4)Individuals whose written informed consent has been obtained. 5)Individuals who can visit an inspection facility and be inspected in designated days. 6)Individuals judged appropriate for the study by the principal.
Key exclusion criteria	1)Individuals using medical products. 2)Individuals having or treated skin disease symptoms. 3)Individuals with strange skin conditions at assessed areas. 4)Individuals having a history of serious hepatopathy, kidney damage, heart disease, lung and blood disease. 5)Individuals who contract or have a history of serious gastrointestinal disease. 6)Individuals with alcoholism or a mental illness. 7)Individuals who used or applied a drug for treatment of disease in the past 1 month. 8)Individuals with probable seasonal allergy during the test. 9)Individuals with food allergy. 10)Individuals with serious anemia. 11)Individuals who are a smoker. 12)Females who are or are possibly pregnant or lactating. 13)Males who usually shave with a razor. 14)Individuals whose life style will change during the test. 15)Individuals who will get sunburned during the test. 16)Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements containing ingredients of the test food in the past 3 months or will ingest them during the test. 17)Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements with the function of improving skin condition in the past 3 months or will ingest them during the test. 18)Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months. 19)Individuals who conducted hormone replacement therapy in the past 6 months. 20)Individuals who have received a cosmetic medicine in the past 6 months. 21)Individuals hospitalized and received treatment in the past 6 months. 22)Individuals who participated in other clinical studies within one month of consent in this study or plan to participate. 23)Individuals having not completed two doses of COVID-19 vaccine. 24)Individuals planning to receive medication or vaccination during the test. 25)Individuals judged inappropriate for the study by the principal.
Target sample size	45

Research contact person
Name of lead principal investigator	1st name Yuko Middle name Last name Matsui
Organization	Morinaga & Co., Ltd.
Division name	Health Science and Research Center, R&D institute
Zip code	230-8504
Address	2-1-1, Shimodueyoshi, Tsurumi-ku, Yokohama
TEL	045-571-6140
Email	y-matsui-jd@morinaga.co.jp

Public contact
Name of contact person	1st name Eriko Middle name Last name Saito
Organization	Morinaga & Co., Ltd.
Division name	Health Science and Research Center, R&D institute
Zip code	230-8504
Address	2-1-1, Shimodueyoshi, Tsurumi-ku, Yokohama, Kanagawa
TEL	045-571-6140
Homepage URL
Email	e-saito-jd@morinaga.co.jp

Sponsor
Institute	Morinaga & Co., Ltd.
Institute
Department

Funding Source
Organization	Morinaga & Co., 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	Non-Profit Organization Japan Aesthetic Dermatology Symposium
Address	8F, Queens Tower C, 2-3-5, Minatomirai, Nishi-ku, Yokohama, Kanagawa
Tel	045-682-4114
Email	info@jp-ads.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	2022 Year 03 Month 31 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	2021 Year 12 Month 06 Day
Date of IRB	2021 Year 12 Month 06 Day
Anticipated trial start date	2022 Year 01 Month 10 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 12 Month 27 Day
Last modified on	2022 Year 06 Month 07 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053005