UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043750
Receipt number R000049945
Scientific Title A study to evaluate the effect of food ingredient in healthy adult on the skin.
Date of disclosure of the study information 2021/04/01
Last modified on 2021/03/26 11:39:45

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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 or person

Institute

Hung Kuang University

Institute

Department

Personal name



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

Value
https://center6.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