UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028924 |
|---|---|
| Receipt number | 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 17:19:38 |
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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
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
yuri.okano@ciel-tokyo.com
Sponsor or person
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
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033099
