UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of a Test Food for Skin Quality, Defecation Improvement and Intestinal Flora
Title of the study (Brief title)	Effects of a Test Food for Skin Quality, Defecation Improvement and Intestinal Flora
Region	Japan

Condition
Condition	N/A(healthy adults)
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to evaluate effects of a test food for skin quality, defecation improvement and intestinal flora.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	[1]Skin quality evaluation (Transepidermal water loss, skin moisture content, skin viscoelasticity, image analysis by VISIA, observation for skin condition by dermatologists)(1) and indexes for evaluating defecation and intestinal flora (analysis of intestinal flora, organic acid analysis, putrefaction products, ammonia analysis, the Japanese Version of the Constipation Assessment Scale [middle term], Bristol stool scale, bowel diary) (2), (3),(4) (1)Transepidermal water loss, skin moisture content, skin viscoelasticity, image analysis by VISIA, observation for skin condition by dermatologists (Week 0, Week 4) (2)analysis of intestinal flora, organic acid analysis, putrefaction products, ammonia analysis (Week 0, Week 4) (3) the Japanese Version of the Constipation Assessment Scale [middle term], Bristol stool scale (Week 0, home survey, Week 4) (4)Bowel diary (from the first day of ingestion of a test material to the last day of the test)
Key secondary outcomes	*Secondary outcome [1]Questionnaire of physical feeling (Week 0, home survey, Week 4) *Safety [1]Doctor's questions (Week 0, Week 4) *Other index [1]Subject's diary(From the first day of ingestion of a test material to the last day of the test)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Oral ingestion of a test food (2 packs once a day for 4 weeks)
Interventions/Control_2
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	60 years-old >
Gender	Female
Key inclusion criteria	[1]Healthy Japanese females aged 30-59 years. [2]Individuals who are aware of skin dryness. [3]Individuals with a tendency for constipation (at 3-4 times of defecation per week). [4]Individuals whose written informed consent has been obtained. [5]Individuals who can have an examination on a designated check day. [6]Individuals judged appropriate for the study by the principal.
Key exclusion criteria	[1]Individuals whose dietary pattern is irregular. [2]Individuals who intake a food containing lactic acid bacterium over 4 days in a week. [3]Individuals using medical products. [4]Individuals who intake laxatives, antiflatulent etc. aiming to improve bowel movements. [5]Individuals who take medicine in the past 1 month to remedy disease. [6]Individuals who take antibiotics in the past 1 month. [7]Individuals with skin disease, such as atopic dermatitis. [8]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, lung disease, or blood disease. [9]Individual who have or had digestive organ disease. [10]Individuals whose BMI is over 30. [11]Individuals who are sensitive to test product or other foods, and medical products. [12]Individuals who are or are possibly pregnant, or are lactating. [13]Individuals who are alcohol dependent or have other mental disabilities. [14]Individuals who are smoker. [15]Individuals with possible changes of life style, such as working a night shift, during the test period. [16]Individuals who will develop seasonal allergy symptoms like hay fever. [17]Individuals who will get sunburned during the test period. [18]Individuals who had a habit to ingest health-promoting foods, or supplements in the past 3 months or will ingest those foods during the test period. [19]Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months. [20]Individuals who use cosmetics having a strong moisturizing effect or improving effect for wrinkle. [21]Individuals who have received a cosmetic medicine. [22]Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months. [23]Individuals who cannot collect fecal samples in their own house and submit them to the designated organization. [24]Individuals who are or whose family is engaged in healthy or functional foods. [25]Individuals judged inappropriate for the study by the principal.
Target sample size	10

Research contact person
Name of lead principal investigator	Shuji Nakata
Organization	Medical Corporation Bokushinkai CLINTEXE Clinic
Division name	Head
Address	4F Atago Green Hills Mori Tower 2-5-1 Atago Minato-ku Tokyo 105-6204, JAPAN
TEL	03-5405-1059
Email	info@tes-h.co.jp

Public contact
Name of contact person	Ryoma Shimizu
Organization	TES Holdings Co., Ltd
Division name	Administrative Department of Clinical Trials
Address	6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN
TEL	03-6801-8480
Homepage URL
Email	r.shimizu@tes-h.co.jp

Sponsor
Institute	TES Holdings Co., Ltd
Institute
Department

Funding Source
Organization	Information is disclosed with permission by the ethical committee.
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 09 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 09 Month 08 Day
Anticipated trial start date	2017 Year 09 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 09 Month 28 Day
Last modified on	2017 Year 12 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033482