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
Classification by malignancy	Others
Genomic information	YES

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 *Viscoelasticity of the skin *Amount of water transpiration from the surface of the skin *VISIA's indicators(spots, wrinkles, texture, pores, UV spots, brown spots, red areas, porphyrins)
Key secondary outcomes	*Oil content of the skin *Defecation frequency *Days of defecation *Fecal properties *Feelings in defecation *Microbiota of gut *Short chain fatty acids of feces *Fecal spoilage products *Moisture of feces *pH of feces *Ammonia of feces * QOL questionnaire *The Japanese Version of the Constipation Assessment Scale MT version (CAS-MT) *Simplified Menopausal Index (SMI) *Body weight, Body fat percentage, BMI *Blood test *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	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Consume testfood-1, one package a day for 10 weeks. Conduct health check, QOL questionnaire and stool analysis at 0, 4 and 8 weeks, skin tests at 4 and 8 weeks, blood tests at 8 weeks after start of the testfood-1 consumption.
Interventions/Control_2	Consume testfood-2, one package a day for 10 weeks. Conduct health check, QOL questionnaire and stool analysis at 0, 4 and 8 weeks, skin tests at 4 and 8 weeks, blood tests at 8 weeks after start of the testfood-2 consumption.
Interventions/Control_3	Consuming 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 4 and 8 weeks, blood tests at 8 weeks after start of control food consumption.
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 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)consume yogurt over 3 days a week. (2)consume lactic acid bacteria beverages and/or bifidobacterium beverages over 3 days a week. (3)consume health food which have intestinal action. (4)consume supplements include lactic bacteria, bifidobacterium and/or yeast over 3 days a week. (5)consume vitamin supplements over 3 days a week. (6)regularly use gastrointestinal agonist and/or female hormone. (7)repeat constipation and diarrhea. (8)defecate under 2 times in a week. (9)defecate over 10 times in a week. (10)have taken antibiotics within a month (11)are being treated uterine and/or that medical historie. (12)are pregnant or are lactating. (13)have allergy to medicine and/or food. (14)are atopic dermatitis, contact dermatitis and/or skin hypersensitivity. (15)Subjects who have birthmark, scar and/or acne on the part of measurement. (16)have severe past and/or current medical history in heart, liver, kidney and/or digestive organs. (17)are heavy drinkers of alcohol. (18)have excess irregular life rhythm such as shift work or midnight work. (19)are currently being treated or who plan to be treated for pollen allergy. (20)have rough skin because of pollen allergy. (21)have excess suntan and/or who stay outside long time. (22)are receiving special care of face and/or arm in the service. (23)plan to go traveling abroad and/or to go swimming in the sea during this test period. (24)are participating, have participated within 4 weeks and/or who plan to participate after informed consent of this test, in clinical test of other medicine or health food. (25)donated over 200mL blood and/or blood components within a month. (26)donated over 400mL blood within the last 4 months. (27)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. (28)Others they have been determined ineligible by principal investigator or sub-investigator.
Target sample size	75

Research contact person
Name of lead principal investigator	1st name Suguru Middle name Last name Fujiwara
Organization	CPCC Company Limited
Division name	Clinical Research Planning Department
Zip code	101-0047
Address	4F Chusin 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 Chusin 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 Group Holdings, 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	2019 Year 09 Month 03 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	75
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 07 Month 26 Day
Date of IRB	2018 Year 07 Month 19 Day
Anticipated trial start date	2018 Year 09 Month 03 Day
Last follow-up date	2018 Year 12 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 08 Month 29 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=R000038715