UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037734 |
|---|---|
| Receipt number | R000043037 |
| Scientific Title | A confirmation study for the improvement effect of skin quality by the test food consumption |
| Date of disclosure of the study information | 2020/08/21 |
| Last modified on | 2020/10/09 11:56:06 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A confirmation study for the improvement effect of skin quality by the test food consumption
Acronym
A confirmation study for the improvement effect of skin quality by the test food consumption
Scientific Title
A confirmation study for the improvement effect of skin quality by the test food consumption
Scientific Title:Acronym
A confirmation study for the improvement effect of skin quality by the test food consumption
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the improvement effect of skin quality by consumption of the test food.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
*Moisture content of the horny layer
*Transepidermal water loss
Key secondary outcomes
*QOL questionnaire
*Stool tests (Physical and chemical analysis, Microbiota of gut)
*Days of defecation
*Defecation frequency
*Fecal properties
*Urine test
* Incidence of adverse events and of side effects
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
Consume test food, one package a day for 10 weeks. Conduct health check, QOL questionnaire and stool analysis at 0, 4 and 8 weeks, skin tests at 0 and 8 weeks, blood tests at 8 weeks after start of the test food consumption.
Interventions/Control_2
Consume control food, one package a day for 10 weeks. Conduct health check, QOL questionnaire and stool analysis at 0, 4 and 8 weeks, skin tests at 0 and 8 weeks, blood tests at 8 weeks after start of the control food consumption.
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
| 49 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Females aged 30 to 49 years old.
2)Subjects who are before menopause and have stable menstrual period within 28 days to 35 days.
3) Subjects who are aware to bad condition of their skin.
4) Subjects who have no habit to consume health food which have intestinal action such as dietary fiber reinforced foods, multigrain rice, oligo sugar.
5) Subjects who have no habit to consume lactic acid bacteria supplements, bifidobacterium supplements, and/or yeast supplements.
6) Subjects who show understanding of the study procedures and agreement with participating the study by written informed consent prior to the study.
Key exclusion criteria
Subjects who
1)have habit to consume yogurt more than 3 days a week.
2)have habit to consume beverages include lactic acid bacteria and/or bifidobacteria more than 2 days a week.
3)have habit to consume vitamin supplements more than 3 days a week.
4)regularly use gastrointestinal drugs or female hormone.
5)have taken antibiotics within a month.
6)are currently being treated or who plan to be treated for pollen allergy.
7)repeat constipation and diarrhea.
8)declared their defecate habit as >= 3 times and/or <= 9 times in a week.
9)have severe past and/or current medical history.
10)are being treated or have medical histories uterine fibroid and/or ovarian cyst.
11)are pregnant or are lactating.
12)have allergy to medicine and/or food.
13)are atopic dermatitis, contact dermatitis and/or skin hypersensitivity.
14)have rough skin because of pollen allergy.
15)have birthmark, scar and/or acne on the part of measurement.
16)have excess suntan and/or who stay outside long time.
17)plan to go traveling abroad and/or to go swimming in the sea during this test period.
18)are receiving special care of face and/or arm in the service.
19)have excess irregular meal cycle and/or have irregular life rhythm.
20)are excessive smoker and/or heavy drinkers of alcohol.
21)are participating, who have participated within 4 weeks and/or who plan to participate after informed consent, in other clinical test.
22)donated over 200mL blood and/or blood components within a month.
23)donated over 400mL blood within the last 4 months.
24)will be collected over 800mL blood and/or blood components when the sampling amounts within the last 12 months are adding to the planned sampling amounts of this study.
25)Others they have been determined ineligible by investigator.
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Suguru |
| Middle name | |
| Last name | Fujiwara |
Organization
CPCC Company Limited
Division name
Division of Clinical Research
Zip code
101-0047
Address
4F Sanwauchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL
03-5297-3112
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Numa |
Organization
CPCC Company Limited
Division name
Planning & Sales Department
Zip code
101-0047
Address
4F Sanwauchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL
03-5297-3112
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Asahi Quality & Innovations, Ltd.
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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Sanwauchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan
Tel
03-5297-5548
IRB@cpcc.co.jp
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
| 2020 | Year | 08 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
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
| 2019 | Year | 08 | Month | 07 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 21 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 19 | Day |
Last modified on
| 2020 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043037
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
