UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049788 |
|---|---|
| Receipt number | R000056613 |
| Scientific Title | The effects of feeding camellia oil made in Goto Islands on skin condition |
| Date of disclosure of the study information | 2023/01/21 |
| Last modified on | 2023/05/17 09:21:58 |
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Basic information
Public title
The effects of feeding camellia oil made in Goto Islands on skin condition
Acronym
The effects of feeding camellia oil on skin condition
Scientific Title
The effects of feeding camellia oil made in Goto Islands on skin condition
Scientific Title:Acronym
The effects of feeding camellia oil on skin condition
Region
| Japan |
Condition
Condition
Healthy adult female
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of feeding camellia oil on skin condition in healthy adult women
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stratum corneum water content
Key secondary outcomes
Transepidermal water loss
skin elasticity
amount of sebum
amount of sebum recovery
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
To take oil 10g/day without Camellia oil for 4 weeks
Interventions/Control_2
To take Camellia oil 10g/day for 4 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
| 50 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Female
Key inclusion criteria
1) Persons with skin problems
2) persons who con moderate their intake of fatty foods
Key exclusion criteria
1) Persons who have a smoking habit
2) persons with a history of serious liver disorder, renal disorder, or heart disease
3) persons with a history of other serious illnesses
4) persons who have received treatment such as immunosuppression within the past 3 months
5) persons who like to eat fatty foods
6) persons who may have an allergic reaction to the test product ingredients
7) persons with chronic skin diseases such as atopic dermatitis
8) persons with scars, warts, pimples, permanent makeup, burns, etc. that affect the evaluation measurement on the face
9) persons who have a history of allergies to cosmetics
10) persons receiving hormone replacement therapy
11) persons who have experience of cosmetic medicine that affects the test site
12) persons who have difficulty maintaining lifestyle habits (eating, exercising, sleeping, skin care, etc.)
13) persons who have difficulty filling in the subject diary
14) pregnant, breastfeeding,or possibly pregnant
15) persons who are participating in other clinical trials at the start of this trial
16) individuals or family members who work for a company that develops, manufactures, or sells food
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kazunari |
| Middle name | |
| Last name | Tanaka |
Organization
Univercity of Nagasaki
Division name
Regional Partnership Center
Zip code
8512195
Address
1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan, 851-2195
TEL
0958135216
katanaka@sun.ac.jp
Public contact
Name of contact person
| 1st name | Shirou |
| Middle name | |
| Last name | Matsumura |
Organization
Univercity of Nagasaki
Division name
Regional Partner Center
Zip code
8512195
Address
1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan, 851-2195
TEL
0958135216
Homepage URL
katanaka@sun.ac.jp
Sponsor or person
Institute
Univercity of Nagasaki
Institute
Department
Personal name
Funding Source
Organization
MTG Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Univercity of Nagasaki
Address
1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan, 851-2195
Tel
0958135216
katanaka@sun.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
| 2023 | Year | 01 | 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
30
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
| 2022 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 20 | 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 | 12 | Month | 15 | Day |
Last modified on
| 2023 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056613
