UMIN-CTR Clinical Trial

Basic information
Public title	A confirmation study for the improvement effect of skin quality by the test food consumption
Acronym	A confirmation study for the improvement effect of skin quality by the test food consumption
Scientific Title	A confirmation study for the improvement effect of skin quality by the test food consumption
Scientific Title:Acronym	A confirmation study for the improvement effect of skin quality by the test food consumption
Region	Japan

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

Objectives
Narrative objectives1	To confirm the improvement effect of skin quality by consumption of the test food.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	*Moisture content of the horny layer *Transepidermal water loss
Key secondary outcomes	*QOL questionnaire *Stool tests (Physical and chemical analysis, Microbiota of gut) *Days of defecation *Defecation frequency *Fecal properties *Urine test * Incidence of adverse events and of side effects

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	Consume test food, one package a day for 10 weeks. Conduct health check, QOL questionnaire and stool analysis at 0, 4 and 8 weeks, skin tests at 0 and 8 weeks, blood tests at 8 weeks after start of the test food consumption.
Interventions/Control_2	Consume control food, one package a day for 10 weeks. Conduct health check, QOL questionnaire and stool analysis at 0, 4 and 8 weeks, skin tests at 0 and 8 weeks, blood tests at 8 weeks after start of the control food consumption.
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	30 years-old <=
Age-upper limit	49 years-old >=
Gender	Female
Key inclusion criteria	1) Females aged 30 to 49 years old. 2)Subjects who are before menopause and have stable menstrual period within 28 days to 35 days. 3) Subjects who are aware to bad condition of their skin. 4) Subjects who have no habit to consume health food which have intestinal action such as dietary fiber reinforced foods, multigrain rice, oligo sugar. 5) Subjects who have no habit to consume lactic acid bacteria supplements, bifidobacterium supplements, and/or yeast supplements. 6) Subjects who show understanding of the study procedures and agreement with participating the study by written informed consent prior to the study.
Key exclusion criteria	Subjects who 1)have habit to consume yogurt more than 3 days a week. 2)have habit to consume beverages include lactic acid bacteria and/or bifidobacteria more than 2 days a week. 3)have habit to consume vitamin supplements more than 3 days a week. 4)regularly use gastrointestinal drugs or female hormone. 5)have taken antibiotics within a month. 6)are currently being treated or who plan to be treated for pollen allergy. 7)repeat constipation and diarrhea. 8)declared their defecate habit as >= 3 times and/or <= 9 times in a week. 9)have severe past and/or current medical history. 10)are being treated or have medical histories uterine fibroid and/or ovarian cyst. 11)are pregnant or are lactating. 12)have allergy to medicine and/or food. 13)are atopic dermatitis, contact dermatitis and/or skin hypersensitivity. 14)have rough skin because of pollen allergy. 15)have birthmark, scar and/or acne on the part of measurement. 16)have excess suntan and/or who stay outside long time. 17)plan to go traveling abroad and/or to go swimming in the sea during this test period. 18)are receiving special care of face and/or arm in the service. 19)have excess irregular meal cycle and/or have irregular life rhythm. 20)are excessive smoker and/or heavy drinkers of alcohol. 21)are participating, who have participated within 4 weeks and/or who plan to participate after informed consent, in other clinical test. 22)donated over 200mL blood and/or blood components within a month. 23)donated over 400mL blood within the last 4 months. 24)will be collected over 800mL blood and/or blood components when the sampling amounts within the last 12 months are adding to the planned sampling amounts of this study. 25)Others they have been determined ineligible by investigator.
Target sample size	110

Research contact person
Name of lead principal investigator	1st name Suguru Middle name Last name Fujiwara
Organization	CPCC Company Limited
Division name	Division of Clinical Research
Zip code	101-0047
Address	4F Sanwauchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL	03-5297-3112
Email	cpcc-contact@cpcc.co.jp

Public contact
Name of contact person	1st name Masanori Middle name Last name Numa
Organization	CPCC Company Limited
Division name	Planning & Sales Department
Zip code	101-0047
Address	4F Sanwauchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL	03-5297-3112
Homepage URL
Email	cpcc-contact@cpcc.co.jp

Sponsor
Institute	CPCC Company Limited
Institute
Department

Funding Source
Organization	Asahi Quality & Innovations, Ltd.
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	Institutional Review Board of Chiyoda Paramedical Care Clinic
Address	2F Sanwauchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan
Tel	03-5297-5548
Email	IRB@cpcc.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

Other administrative information
Date of disclosure of the study information	2020 Year 08 Month 21 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	2019 Year 08 Month 07 Day
Date of IRB	2019 Year 07 Month 19 Day
Anticipated trial start date	2019 Year 08 Month 21 Day
Last follow-up date	2019 Year 12 Month 24 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 08 Month 19 Day
Last modified on	2020 Year 10 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043037