UMIN-CTR Clinical Trial

Basic information
Public title	Study for the effect of intake of test drink on skin SWE-2018-05-HD1101
Acronym	Study for the effect of intake of test drink on skin
Scientific Title	Study for the effect of intake of test drink on skin SWE-2018-05-HD1101
Scientific Title:Acronym	Study for the effect of intake of test drink on skin
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of drink intake on skin
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Measurement of skin condition (screening, Week 0, Week 4, Week 8, Week 12)
Key secondary outcomes	questionnaire (screening, Week 0, Week 4, Week 8, Week 12)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Drink containing food ingredients, 12 Weeks
Interventions/Control_2	Drink not containing food ingredients, 12 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	40 years-old <=
Age-upper limit	65 years-old >
Gender	Female
Key inclusion criteria	(1)Women aged 40 to 64 years at the time of acquisition of agreement in participating in this study. (2)Those who can visit the specified institution on the scheduled day of visit (3)Those who adequately understand the objective and details of this study, and give written informed consent
Key exclusion criteria	(1)Subjects who are or are possibly pregnant, or are lactating. (2)Subjects who are; a)With present heart disorder, liver disorder, or kidney disorder, b)With history of cardiac disorder, c)With diabetes mellitus, or d)With allergy to the study foods. (3)Subjects who are with treatment (4)Subjects who are with skin disease, such as atopic dermatitis. (5)Subjects who are with strange skin conditions at measurement points. (6)Subjects who cannot avoid daylight exposure (such as sunbathing, tanning machine) during the test period. (7)Subjects who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements claiming to improve skin condition the past 3 months or will ingest those foods during the test period. (8)Subjects who had been conducted an operation on the test spot in the past 1 year. (9)Subjects who have a habit to use drug claiming to improve skin condition in the past 3 months. (10)Subjects judged inappropriate for the study by the principal.
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takao Tanaka
Organization	SUNTORY WELLNESS LIMITED
Division name	Institute for Health Care Science
Zip code
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL	050-3182-0590
Email	Takao_Tanaka@suntory.co.jp

Public contact
Name of contact person	1st name Middle name Last name Wakana Taguchi
Organization	SUNTORY WELLNESS LIMITED
Division name	Institute for Health Care Science
Zip code
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL	050-3182-6122
Homepage URL
Email	Wakana_Taguchi@suntory.co.jp

Sponsor
Institute	SUNTORY WELLNESS LIMITED
Institute
Department

Funding Source
Organization	SUNTORY WELLNESS LIMITED
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
Address
Tel
Email

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	2018 Year 12 Month 02 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	2018 Year 11 Month 15 Day
Date of IRB	2018 Year 11 Month 15 Day
Anticipated trial start date	2018 Year 12 Month 02 Day
Last follow-up date	2019 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2019 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date	2018 Year 11 Month 28 Day
Last modified on	2019 Year 12 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039953