UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effects on skin elasticity and hormone levels of blood by long-term ingestion of test food in human: a double-blind, randomized placebo-controlled, parallel comparison study
Title of the study (Brief title)	The effects on skin elasticity and hormone levels of blood by long-term ingestion of test food in human
Region	Japan

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

Objectives
Narrative objectives1	To investigate the effects of test food on skin elasticity and blood level of hormones
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Skin elasticity
Key secondary outcomes	Blood level of hormones Skin condition Safety evaluation

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	Ingestion of test food for 8 weeks
Interventions/Control_2	Ingestion of placebo for 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	50 years-old >
Gender	Male and Female
Key inclusion criteria	1) Subjects aged from 30 to 49 years old at the time informed consent is provided. 2) Subjects who show relatively low levels of blood polypeptides. 3) Subjects who show relatively low skin moisture and skin elasticity. 4) Subjects whose BMI is less than 25. 5) Subjects who can visit to the administrative facility on every inspection day. 6) Subjects who provide the written informed consent for the involvement of this trial by themselves.
Key exclusion criteria	1) Subjects who continuously take a functional food or a supplement. 2) Subjects who continuously take a functional food or quasi-medicine which has same or similar effect with active ingredient of test food. 3) Subjects who frequently intake food which is rich in same active ingredient of test food, or who intake these kind of food during 3 days before and after trial initiation and the last 3 days from the end of trial. 4) Subjects who work on the night shift or the day and night shift. 5) Subjects who are receiving the medical treatment or the prophylactic treatment, or who are diagnosed the need of medical treatment. 6) Subjects who have skin disease or abnormality in skin condition such as atopic dermatitis. 7) Subjects who show the apparent change of skin condition which is not related to the intake of test food at the end of trial compared with the initiation. 8) Subjects who have a past history for the severe disease or abnormality in glucose metabolism, lipid metabolism, liver function, kidney function, cardiovascular system including heart function, respiratory tract, endocrine system and nerve system, or for psychiatric disorder. 9) Subjects who suffer from anemia, or felt sick due to blood collection. 10) Subjects who have a past history of alcoholism or drug addiction. 11) Subjects who have a risk for food allergy. 12) Subjects who show apparent abnormality in blood test, or who are positive for HBs antigen or HCV antibody in trial duration including the screening period. 13) Subjects who are pregnant or during lactation when the informed consent is provided, or who hope to become pregnant during the trial. 14) Subjects who were involved in another trial within 4 weeks prior to this trial, who will participate in another trial. 15) Subjects who are judged to be inappropriate for this trial by the doctor who is responsible for this trial.
Target sample size	20

Research contact person
Name of lead principal investigator	Dr. Sumio Kondo
Organization	Medical Corpoation Kenshokai Fukushima Healthcare Center
Division name	Medical Corpoation Kenshokai Fukushima Healthcare Center
Address	2-12-13, Tamagawa, Fukushima-ku, Osaka, Japan
TEL	81-(0)6-6882-1130
Email	s.kondo@drc-web.co.jp

Public contact
Name of contact person	Yuri Okano
Organization	CIEL Corporation
Division name	CIEL Corporation
Address	Renafine 302, 2-10-11, Midori, Sumida-ku, Tokyo
TEL	03-6659-2767
Homepage URL
Email	yuri.okano@ciel-tokyo.com

Sponsor
Institute	DRC Corporation, Ltd. Product Testing Department No.9 Tabuchi Bldg. 3F, 2-10-31, Higashi-Temma, Kita-ku, Osaka Tel: 81-(0)6-6882-1130
Institute
Department

Funding Source
Organization	FUJIFILM Corporation
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	2019 Year 03 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 08 Month 18 Day
Anticipated trial start date	2017 Year 09 Month 25 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	Published
URL releasing results	https://www.mdpi.com/1660-3397/16/12/482/htm
Results
Other related information

Management information
Registered date	2017 Year 08 Month 31 Day
Last modified on	2019 Year 03 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033099