UMIN-CTR Clinical Trial

Basic information
Public title	Human studies on the usefulness of fermented foods
Acronym	Human studies on the usefulness of fermented foods
Scientific Title	Human studies on the usefulness of fermented foods
Scientific Title:Acronym	Human studies on the usefulness of fermented foods
Region	Japan

Condition
Condition	Skin improvement
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To observe the dynamics of intestinal bacteria and improvement of skin.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Skin condition 6 weeks after the start of intake and 6 weeks after the end of intake
Key secondary outcomes

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	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Amazake 35g/day for 6 weeks
Interventions/Control_2	Drink with fermented rice extract 15g/day for 6 weeks
Interventions/Control_3	Placebo drink 15g/day for 6 weeks
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Adult 2.a person with giving informed consent
Key exclusion criteria	1,a person with a history of allergy to rice-related materials (rice, amazake, sake, etc.) 2,Those who already use Yushin Shuzo products 3,Those with trauma that is difficult to measure at the measurement site (face) 4,Those who plan to perform treatment such as excessive UV exposure or esthetic during the test period 5,Others that the investigator deems inappropriate
Target sample size	75

Research contact person
Name of lead principal investigator	1st name Yasuyuki Middle name Last name Irie
Organization	Okayama Prefectural University
Division name	Faculty of Health and Welfare Science
Zip code	719-1197
Address	111 Kuboki, Soja-shi, Okayama
TEL	0866-94-2111
Email	yirie@fhw.oka-pu.ac.jp

Public contact
Name of contact person	1st name Rikako Middle name Last name Inoue
Organization	Okayama Prefectural University
Division name	Faculty of Health and Welfare Science
Zip code	719-1197
Address	111 Kuboki, Soja-shi, Okayama
TEL	0866-94-2111
Homepage URL
Email	rinoue@fhw.oka-pu.ac.jp

Sponsor
Institute	Okayama Prefectural University
Institute
Department

Funding Source
Organization	Okayama Prefectural University
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	Okayama Prefectural University
Address	111 Kuboki, Soja-shi, Okayama
Tel	0866-94-2111
Email	rinoue@fhw.oka-pu.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 01 Month 15 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	100
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	Preinitiation
Date of protocol fixation	2020 Year 10 Month 02 Day
Date of IRB	2020 Year 11 Month 22 Day
Anticipated trial start date	2022 Year 01 Month 01 Day
Last follow-up date	2024 Year 03 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 01 Month 15 Day
Last modified on	2021 Year 01 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044628