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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000039342
Receipt No. R000044872
Scientific Title The effects of food ingestion on face skin
Date of disclosure of the study information 2020/02/10
Last modified on 2020/08/03

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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/ctr_e/ctr_view.cgi?recptno=R000044872

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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