UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of a Test Food for Skin Conditions
Title of the study (Brief title)	Effects of a Test Food for Skin Conditions
Region	Japan

Condition
Condition	N/A(healthy adaults)
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to examine effects of a test food for skin conditions.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	[1]Indexes for skin conditions (skin moisture content, transepidermal water loss, skin viscoelasticity, visual evaluation: Week 0, Week 4, Week 8)
Key secondary outcomes	[1]Doctor's questions (Week 0, Week 4, Week 8) [2]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	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	Treatment
Type of intervention	Food
Interventions/Control_1	Oral ingestion of the test food (8 weeks)
Interventions/Control_2	Oral ingestion of the placebo food (8 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	30 years-old <=
Age-upper limit	60 years-old >
Gender	Male and Female
Key inclusion criteria	[1]Japanese females aged 30-59 years. [2]Individuals who are healthy and are not suffered from a chronic malady including skin disease. [3]Individuals who are anxious about skin dryness. [4]Individuals whose written informed consent has been obtained. [5]Individuals who can visit an inspection facility and be inspected in designated days. [6]Individuals judged appropriate for the study by the principal.
Key exclusion criteria	[1]Individuals using medical products. [2]Individuals with skin disease, such as atopic dermatitis. [3]Individuals with strange skin conditions at measurement points. [4]Individuals who used or applied a drug for treatment of disease in the past 1 month. [5]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, hematological and blood disease. [6]Individuals who contract or have a history of serious gastrointestinal disease. [7]Individuals with serious anemia. [8]Individuals who are sensitive to test product (especially gelatin, leg meat, pork) or other foods, and medical products. [9]Females who are or are possibly pregnant, or are lactating. [10]Males who shave with a razor. [11]Individuals who have an addiction to alcohol or a mental illness. [12]Individuals who are a smoker. [13]Individuals whose life style will change during the test period. [14]Individuals with probable seasonal allergy, such as pollinosis, during the test period. [15]Individuals who will get sunburned during the test period. [16]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements in the past 3 months or will ingest those foods during the test period. [17]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements in the past 3 months or will ingest those foods during the test period. [18]Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months. [19]Individuals who conducted hormone replacement therapy in the past 3 months or have a history of conducting hormone replacement therapy. [20]Individuals who have received a cosmetic medicine in the past 6 months. [21]Individuals who were hospitalized and received treatment in the past 6 months. [22]Individuals who participated in other clinical studies in the past three months. [23]Individuals judged inappropriate for the study by the principal.
Target sample size	36

Research contact person
Name of lead principal investigator	Sadao Mori
Organization	MORINAGA&CO., LTD.
Division name	Internal Department
Address	2-1-1 Shimosueyoshi Tsurumi-ku Yokohama-Shi Kanagawa 230-0012, JAPAN
TEL	070-3864-8266
Email	s-mori-ab@morinaga.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	Morinaga & Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
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 11 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 08 Month 17 Day
Anticipated trial start date	2017 Year 09 Month 08 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 11 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=R000033162