UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of effects of test food on skin moisture of females: a pilot study
Acronym	Evaluation of effects of test food on skin moisture
Scientific Title	Evaluation of effects of test food on skin moisture of females: a pilot study
Scientific Title:Acronym	Evaluation of effects of test food on skin moisture
Region	Japan

Condition
Condition	No
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of test food on skin moisture in healthy females.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Skin hydration in stratum corneum and transepidermal water loss
Key secondary outcomes	Composition of fecal microbiota

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	Consumption of test food (for 4 weeks)
Interventions/Control_2	Consumption of placebo food (for 4 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	18 years-old <=
Age-upper limit	60 years-old >
Gender	Female
Key inclusion criteria	1. Who have subjective symptoms of dry skin 2. Who belong to Showa Women's University
Key exclusion criteria	1. Who have any skin disease 2. Who have any serious illness, for example, heart disease, kidney disease, diabetes mellitus, and so on. 3. Who take any medicine which effects intestinal flora, such as antibiotics. 4. Who have allergic to test food or placebo food. 5. Who expose to high-intensity ultraviolet rays. 6. Who are pregnant or breast-feeding or willing to be pregnant during this study. 7. Who have receive medical treatments for gastrointestinal diseases that affect regulation of intestinal function, or a history of those (except for appendicectomy). 8. Who have participated in other clinical study during this study, or willing to do that. 9. Who are judged unsuitable for this study by principal investigator.
Target sample size	70

Research contact person
Name of lead principal investigator	1st name Shigenori Middle name Last name Suzuki
Organization	KAGOME CO., LTD.
Division name	Nature & Wellness Research Department
Zip code	329-2762
Address	17 Nishitomiyama, Nasushiobara city, Tochigi
TEL	0287-36-2935
Email	Shigenori_Suzuki@kagome.co.jp

Public contact
Name of contact person	1st name Naoko Middle name Last name Waki
Organization	KAGOME CO., LTD.
Division name	Nature & Wellness Research Department
Zip code	329-2762
Address	17 Nishitomiyama, Nasushiobara city, Tochigi
TEL	0287-36-2935
Homepage URL
Email	Naoko_Waki@kagome.co.jp

Sponsor
Institute	KAGOME CO., LTD.
Institute
Department

Funding Source
Organization	KAGOME CO., LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Showa Women's University
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kagome Ethics Committee
Address	3-21-1, F tower, Hamacho, Nihonbashi, Tyuo-ku, Tokyo, Japan
Tel	03-5623-8501
Email	Takuji_Hayakawa@kagome.co.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	昭和女子大学（東京都）

Other administrative information
Date of disclosure of the study information	2019 Year 11 Month 06 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	76
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 10 Month 29 Day
Date of IRB	2019 Year 10 Month 29 Day
Anticipated trial start date	2019 Year 11 Month 12 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2020 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date	2019 Year 11 Month 05 Day
Last modified on	2020 Year 04 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043865