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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028924
Receipt No. R000033099
Scientific Title 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
Date of disclosure of the study information 2019/03/30
Last modified on 2019/03/01

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Basic information
Public title 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
Acronym The effects on skin elasticity and hormone levels of blood by long-term ingestion of test food in human
Scientific Title 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
Scientific Title:Acronym 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
1st name
Middle name
Last name Dr. Sumio Kondo
Organization Medical Corpoation Kenshokai Fukushima Healthcare Center
Division name Medical Corpoation Kenshokai Fukushima Healthcare Center
Zip code
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
1st name
Middle name
Last name Yuri Okano
Organization CIEL Corporation
Division name CIEL Corporation
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.mdpi.com/1660-3397/16/12/482/htm
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
2017 Year 08 Month 18 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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