UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000046601 |
|---|---|
| Receipt number | R000053160 |
| Scientific Title | Verification of skin condition improvement effect by intake of food |
| Date of disclosure of the study information | 2023/01/12 |
| Last modified on | 2023/01/12 12:29:17 |
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Basic information
Public title
Verification of skin condition improvement effect by intake of food
Acronym
Verification of skin condition improvement effect by intake of food
Scientific Title
Verification of skin condition improvement effect by intake of food
Scientific Title:Acronym
Verification of skin condition improvement effect by intake of food
Region
| Japan |
Condition
Condition
Healthy female subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effect of skin condition improvement for women by food intake.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
skin properties
Defecation condition
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Continuous consumption of the test-food 80 g to the subjects, once a day (between lunch and dinner) for 8 weeks.
Interventions/Control_2
Non-ingestion
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)Healthy female subjects ranging in age from 30 to 49, at the time point of giving informed consent to take part in this trial.
(2)Subjects who are concerned about their dry skin.
(3)Subjects with a tendency for constipation
Key exclusion criteria
(1)Subjects who have previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs.
(2)Subjects with some kind of medical treatment continuously.
(3)Pregnant, possibly pregnant, or lactating women.
(4)Subjects with excessive suntan, and/or some kind of work/sport outside for a long time.
(5)Subjects with some kind of specific care outside, and/or planning to receive the care during this trial.
(6)Subjects with atopic dermatitis, contact dermatitis, sensitive skin.
(7)Subjects taking steadily in the health-specific/functional/health foods, which might affect the test results.
(8)Subjects with previous medical history of the allergy to test-food.
(9)Subjects with menopause.
(10) Subjects who are now under the other clinical tests.
(11)Subjects who take the test-food at least once a week.
(12)Subjects with extremely irregular life rhythms, midnight work and/or irregular shift one.
(13)Subjects with excessive alcohol intake.
(14)A person who is judged inappropriate to join the study by doctor in charge.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Yanagimoto |
Organization
Nippon Suisan Kaisha, Ltd.
Division name
Food Function R&D Center
Zip code
105-8676
Address
1-3-1 Nishishinbashi, Minato, Tokyo
TEL
080-2098-2093
yanagimoto@nissui.co.jp
Public contact
Name of contact person
| 1st name | Eriko |
| Middle name | |
| Last name | Yoshida |
Organization
Nippon Suisan Kaisha, Ltd.
Division name
Food Function R&D Center
Zip code
105-8676
Address
1-3-1 Nishishinbashi, Minato, Tokyo
TEL
080-8088-6685
Homepage URL
eriko_yoshida@nissui.co.jp
Sponsor or person
Institute
SOUKEN
Institute
Department
Personal name
Funding Source
Organization
Nippon Suisan Kaisha 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
Shiba Palace Clinic
Address
6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo
Tel
03-5408-1599
jimukyoku@mail.souken-r.com
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
| 2023 | Year | 01 | Month | 12 | 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
| 2021 | Year | 12 | Month | 09 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 12 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 01 | Month | 11 | Day |
Last modified on
| 2023 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053160
| Research Plan | |
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| Registered date | File name |
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