UMIN-CTR Clinical Trial

Basic information
Public title	Effect of ingestion of fermented milk food on the skin in healthy subjects
Acronym	Effect of ingestion of fermented milk food on the skin
Scientific Title	Effect of ingestion of fermented milk food on the skin in healthy subjects
Scientific Title:Acronym	Effect of ingestion of fermented milk food on the skin
Region	Japan

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

Objectives
Narrative objectives1	To investigate effects of fermented milk food on the skin in healthy adults
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Corneous moisture content
Key secondary outcomes	Skin elasticity, Transepidermal water loss

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	Treatment
Type of intervention	Food
Interventions/Control_1	8weeks Placebo food Once a day
Interventions/Control_2	8weeks Fermented milk food Once a day
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	59 years-old >=
Gender	Male and Female
Key inclusion criteria	Healthy adults
Key exclusion criteria	1.Persons who consume functional foods or medicines that affect the skin 2.Persons who experienced cosmetic medicine or hormone replacement therapy 3.Persons who have undergone esthetic treatment on the skin of the measurement site during the month before this trial 4.Persons who got browned for a long time 5.Persons who have a habit to wash body strongly 6.Persons who have scratches or inflammations the skin of the measurement site 7.Persons who occur skin disorders before and after a menstrual period 8.Persons of irregular habits 9.Persons who have food allergies for test foods 10.Persons who have serious conditions 11.Persons who have a plan to participate in other clinical study during current study 12.Persons who are pregnant or may become pregnant 13.Other persons who are judged by the investigator to be inappropriate for this study
Target sample size	70

Research contact person
Name of lead principal investigator	1st name Kentaro Middle name Last name Shoji
Organization	Otsuma Women's University
Division name	Department of Food Science, Faculty of Home Economics
Zip code	102-8357
Address	12 Sanban-cho,Chiyoda-ku,Tokyo
TEL	0352756086
Email	shoji@otsuma.ac.jp

Public contact
Name of contact person	1st name Kentaro Middle name Last name Shoji
Organization	Otsuma Women's University
Division name	Department of Food Science, Faculty of Home Economics
Zip code	102-8357
Address	12 Sanban-cho,Chiyoda-ku,Tokyo
TEL	0352756086
Homepage URL
Email	shoji@otsuma.ac.jp

Sponsor
Institute	Otsuma Women's University
Institute
Department

Funding Source
Organization	Milk Lab. 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	Ethical review committee of Otsuma Women's University
Address	12 Sanban-cho,Chiyoda-ku,Tokyo
Tel	0352756408
Email	kenkyu.s@ml.otsuma.ac.jp

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 07 Month 07 Day

Related information
URL releasing protocol	Unpublished due to the protocol including the intellectual property rights
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	2021 Year 04 Month 20 Day
Date of IRB	2021 Year 06 Month 07 Day
Anticipated trial start date	2021 Year 06 Month 08 Day
Last follow-up date	2022 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 07 Month 07 Day
Last modified on	2022 Year 06 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051151