UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053462 |
|---|---|
| Receipt number | R000061017 |
| Scientific Title | A Double-Blind, Randomized, Controlled Trial of Oral Intake of Rice Oil High in Polyphenols and Phytosterols to Improve Skin Condition |
| Date of disclosure of the study information | 2024/03/01 |
| Last modified on | 2024/01/30 08:05:23 |
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Basic information
Public title
A Double-Blind, Randomized, Controlled Trial of Oral Intake of Rice Oil High in Polyphenols and Phytosterols to Improve Skin Condition
Acronym
A Double-Blind, Randomized, Controlled Trial of Oral Intake of Rice Oil High in Polyphenols and Phytosterols to Improve Skin Condition
Scientific Title
A Double-Blind, Randomized, Controlled Trial of Oral Intake of Rice Oil High in Polyphenols and Phytosterols to Improve Skin Condition
Scientific Title:Acronym
A Double-Blind, Randomized, Controlled Trial of Oral Intake of Rice Oil High in Polyphenols and Phytosterols to Improve Skin Condition
Region
| Japan |
Condition
Condition
healthy people
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the improvement of skin condition by oral consumption of rice oil high in polyphenols and phytosterols.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
change of water content in the epidermis after 12 weeks of intake
Key secondary outcomes
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
test capsule
Interventions/Control_2
placebo capsule
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. men and women between the ages of 20 and 60 at the time consent is obtained.
2. healthy and free from chronic physical diseases. The applicant must be able to confirm this by interview with the physician in charge of the study. 3.
3. The applicant must not be using any medicated cosmetics, supplements, or other products that are expected to have related efficacy.
4. have been fully informed of the purpose and content of the study, have the capacity to consent, and are willing to voluntarily participate in the study based on a thorough understanding of the purpose and content of the study, and are able to consent to participation in the study in writing.
5. Be able to come to the office on the designated examination date and undergo the examination.
6. who have been approved by the study physician as appropriate to participate in the study.
Key exclusion criteria
1. who currently suffer from any disease and are under medication. 2.
2. who have been determined by the examining physician to have a serious skin condition such as dermatitis. 3. who are unable to intentionally refrain from direct exposure to the sun during the examination period.
3. who cannot intentionally refrain from being exposed to direct sunlight, such as sunburn, during the examination period. 4. who are allergic (to drugs or test materials).
4. those who have allergies (to pharmaceuticals or products related to the test materials) 5. those who are pregnant or nursing
5. who is pregnant, lactating, or intends to become pregnant during the study period
6. who are currently, or have been within the past month at the time of consent, in the habit of continuously ingesting or applying a drug that claims to improve the skin in relation to the area to be measured. 7. who are in the habit of applying a drug that claims to improve the skin in relation to the area to be measured.
7. who are otherwise deemed by the investigator to be inappropriate for the study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Masatoshi |
| Middle name | |
| Last name | Jinnin |
Organization
Wakayama Medical University
Division name
Dermatology
Zip code
641-0012
Address
811-1 Kimiidera, Wakayama
TEL
073-447-2300
mjin@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Masatoshi |
| Middle name | |
| Last name | Jinnin |
Organization
Wakayama Medical University
Division name
Dermatology
Zip code
641-0012
Address
811-1 Kimiidera, Wakayama
TEL
073-447-2300
Homepage URL
mjin@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Tsuno Group Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
industrial technology center of wakayama prefecture
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Wakayama Medical University
Address
811-1 Kimiidera, Wakayama
Tel
073-447-2300
wa-rinri@wakayama-med.ac.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
| 2024 | Year | 03 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 01 | Month | 27 | Day |
Last modified on
| 2024 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061017
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
