UMIN-CTR Clinical Trial

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

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

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

Assessment
Primary outcomes	Noticeable pores (number)
Key secondary outcomes	Wrinkles (number),Skin color tone, Skin clearness, Skin lightning, Skin elasticity, Sagging, Resting liquid volume, Height, body weight, BMI, Intake rate of test food or placebo food

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) 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	Test food ( 6 weeks intake)
Interventions/Control_2	Placebo food (6 weeks intake)
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	Female
Key inclusion criteria	(1) Females from 20 to 60 years of age (2) Healthy females who do not eat much test food in a day (3) Subjects giving written informed consent (4) No skin disease such as atopic dermatitis rash
Key exclusion criteria	(1) Individuals having symptoms that affect test food ingestion (2) Individuals taking medications that may affect results (3)Individuals who may develop allergies in connection with the test (4) Individuals who have the will of pregnancy or are breast-feeding during the study period (5)Individuals who find it difficult to continue test food ingestion during the period (6)Individuals deemed inappropriate by the study director to participate in the study (7) Individuals with skin problems (wounds that hinder examination) or diseases (such as atopic dermatitis rash) (8) Individuals with serious diseases such as diabetes, liver disease, and heart disease (9) Individuals who regularly take medications that require a doctor's prescription (10) Individuals who plan to tan in outdoor sports * from the first month of the test until the end of the test (11) Individuals who cannot use the same skin care and cosmetics during the test period (12) Individuals undergoing treatments such as at a beauty care institution or esthetic that may affect the test results during the test period (13) Individuals who are judged as unsuitable for the study by the investigator for the other reasons *:Sunburn within daily life is allowed.
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	048-837-0187
Email	oosawa_kenji@lotte.co.jp

Public contact
Name of contact person	1st name Misaki Middle name Last name Matsui
Organization	Lotte Co., Ltd.
Division name	Central Laboratory, Food Material Development Section
Zip code	336-8601
Address	1-1, Numakage-3chome, Minami-ku, Saitama
TEL	048-837-0187
Homepage URL
Email	matsui_misaki@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 02 Month 10 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	Terminated
Date of protocol fixation	2019 Year 12 Month 12 Day
Date of IRB	2019 Year 12 Month 12 Day
Anticipated trial start date	2020 Year 02 Month 11 Day
Last follow-up date	2020 Year 04 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 01 Month 31 Day
Last modified on	2020 Year 08 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044872