UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038493 |
|---|---|
| Receipt number | R000043865 |
| Scientific Title | Evaluation of effects of test food on skin moisture of females: a pilot study |
| Date of disclosure of the study information | 2019/11/06 |
| Last modified on | 2020/04/14 09:44:19 |
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Basic information
Public title
Evaluation of effects of test food on skin moisture of females: a pilot study
Acronym
Evaluation of effects of test food on skin moisture
Scientific Title
Evaluation of effects of test food on skin moisture of females: a pilot study
Scientific Title:Acronym
Evaluation of effects of test food on skin moisture
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of test food on skin moisture in healthy females.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin hydration in stratum corneum and transepidermal water loss
Key secondary outcomes
Composition of fecal microbiota
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
Consumption of test food (for 4 weeks)
Interventions/Control_2
Consumption of placebo food (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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
1. Who have subjective symptoms of dry skin
2. Who belong to Showa Women's University
Key exclusion criteria
1. Who have any skin disease
2. Who have any serious illness, for example, heart disease, kidney disease, diabetes mellitus, and so on.
3. Who take any medicine which effects intestinal flora, such as antibiotics.
4. Who have allergic to test food or placebo food.
5. Who expose to high-intensity ultraviolet rays.
6. Who are pregnant or breast-feeding or willing to be pregnant during this study.
7. Who have receive medical treatments for gastrointestinal diseases that affect regulation of intestinal function, or a history of those (except for appendicectomy).
8. Who have participated in other clinical study during this study, or willing to do that.
9. Who are judged unsuitable for this study by principal investigator.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Shigenori |
| Middle name | |
| Last name | Suzuki |
Organization
KAGOME CO., LTD.
Division name
Nature & Wellness Research Department
Zip code
329-2762
Address
17 Nishitomiyama, Nasushiobara city, Tochigi
TEL
0287-36-2935
Shigenori_Suzuki@kagome.co.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Waki |
Organization
KAGOME CO., LTD.
Division name
Nature & Wellness Research Department
Zip code
329-2762
Address
17 Nishitomiyama, Nasushiobara city, Tochigi
TEL
0287-36-2935
Homepage URL
Naoko_Waki@kagome.co.jp
Sponsor or person
Institute
KAGOME CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
KAGOME CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Showa Women's University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagome Ethics Committee
Address
3-21-1, F tower, Hamacho, Nihonbashi, Tyuo-ku, Tokyo, Japan
Tel
03-5623-8501
Takuji_Hayakawa@kagome.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
昭和女子大学（東京都）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 11 | Month | 06 | 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
76
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 | 10 | Month | 29 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 12 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 11 | Month | 05 | Day |
Last modified on
| 2020 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043865
