UMIN-CTR Clinical Trial

Basic information
Public title	A study to evaluate the effect of food ingredient in healthy adult on the skin.
Acronym	A study to evaluate the effect of food ingredient in healthy adult on the skin.
Scientific Title	A study to evaluate the effect of food ingredient in healthy adult on the skin.
Scientific Title:Acronym	A study to evaluate the effect of food ingredient in healthy adult on the skin.
Region	Asia(except Japan)

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

Objectives
Narrative objectives1	To evaluate the effect of test food intake for 12 consecutive weeks on skin using placebo as a control
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Skin indicators such as wrinkles and moisture content
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	Ingestion of test food(research food)
Interventions/Control_2	Ingestion of placebo
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	35 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	1. Male and female subjects aged 30-65 years. 2.Not currently taking any health, nutritional, herbal supplement for skin. 3.Not currently under-going any medical treatment (including laser treatment, face-lift, skin-peel). 4.Not using any topical application cream for skin treatment prescribed by doctors or dermatologists.
Key exclusion criteria	1.Recent (within last 2 months) or currently undergoing any medical treatment for skin (including laser treatment, face-lift or skin-peel). 2.Continuously taking functional ingredients as a medicine or a dietary supplement or currently taking oral or topical medication which may affect the test result 3.Recently or currently suffering from any infectious or non-infectious skin diseases (including eczema and acne) 4.Pregnant, possibly pregnant, or lactating 5.Participating in another clinical test 6.Heavy smoker and/ or heavy drinker. 7.Allergy to any marine component, or any active component contained in supplement. 8.During the study, participants were advised not to change their lifestyle or usual habits (eg, using skin care product) and not to change or stop intake of estrogen or progesterone.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Tzu-Fang Middle name Last name Hsu
Organization	Hung Kuang University
Division name	Department of Applied Cosmetology and Graduate Institute of Cosmetic Science
Zip code	433304
Address	No. 1018, Sec. 6, Taiwan Boulevard, Shalu District, Taichung City 433304, Taiwan
TEL	886-4-26318652
Email	tzufang@hk.edu.tw

Public contact
Name of contact person	1st name Mariko Middle name Last name Oe
Organization	Kewpie Corporation
Division name	R&D Division
Zip code	182-0002
Address	2-5-7, Sengawa-cho, Chofu-shi, Tokyo 182-0002, Japan
TEL	03-5384-7759
Homepage URL
Email	mariko_oe@kewpie.co.jp

Sponsor
Institute	Hung Kuang University
Institute
Department

Funding Source
Organization	Kewpie Corporation
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	Institutional review board of Antai Medical Care Cooperation Antai Tian-Sheng Memorial Hospital
Address	No. 210, Sec. 1, Zhongzheng Rd., Donggang Township, Pingtung County 928004, Taiwan
Tel	+886-8-832-9966
Email	tsmhirb2018@gmail.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	2021 Year 04 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	40
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	2019 Year 03 Month 06 Day
Date of IRB	2019 Year 05 Month 06 Day
Anticipated trial start date	2019 Year 03 Month 24 Day
Last follow-up date	2021 Year 12 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 03 Month 26 Day
Last modified on	2021 Year 03 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049945

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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