UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031284 |
|---|---|
| Receipt number | R000035442 |
| Scientific Title | Effect of a Test Food for Skin |
| Date of disclosure of the study information | 2018/02/15 |
| Last modified on | 2019/09/05 14:09:49 |
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Basic information
Public title
Effect of a Test Food for Skin
Acronym
Effect of a Test Food for Skin
Scientific Title
Effect of a Test Food for Skin
Scientific Title:Acronym
Effect of a Test Food for Skin
Region
| Japan |
Condition
Condition
N/A(healthy adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examines effects of the test food on male's and female's skin condition.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
[1]Skin quality evaluation (skin moisture content, Transepidermal water loss, observation for skin condition by dermatologists) (before and afte ingestion).
Key secondary outcomes
*Secondary outcomes
[1]Blood phenol level (before and afte ingestion).
[2]Blood p-cresol level (before and afte ingestion).
[3]Subject's diary (From the first day of ingestion of a test material to the last day of the test).
[4]Questionnaire of physical feeling (before and afte ingestion).
*Safety
[1]Hematologic test (before and afte ingestion).
[2]Blood biochemical test (before and afte ingestion).
[3]Urine analysis (before and afte ingestion).
[4]Doctor's questions (before and afte ingestion).
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
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Oral ingestion of the test food (1 pack once a day for 8 weeks).
Interventions/Control_2
Oral ingestion of the placebo food (1 pack once a day for 8 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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
[1]Healthy Japanese males and females aged 20-59 years.
[2]Individuals who are healthy and have no chronic physical disease including skin disease.
[3]Individuals who are aware of skin dryness.
[4]Individuals with a tendency for constipation (at 4 times or less of defecation per week).
[5]Individuals whose written informed consent has been obtained.
[6]Individuals who can have an examination on a designated check day.
[7]Individuals judged appropriate for the study by the principal.
Key exclusion criteria
[1]Individuals using medical products.
[2]Individuals with skin disease, such as atopic dermatitis.
[3]Individuals with strange skin conditions at measurement points.
[4]Individuals who used or applied a drug for treatment of disease in the past 1 month.
[5]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, hematological and blood disease.
[6]Individuals who contract or have a history of serious gastrointestinal disease.
[7]Individuals with serious anemia.
[8]Individuals who are sensitive to test product or other foods, and medical products.
[9]Females who aware of rough skin before and after menstruation.
[10]Individuals who are or are possibly pregnant, or are lactating.
[11]Individuals who have an addiction to alcohol or a mental illness.
[12]Individuals who are a smoker.
[13]Individuals with possible changes of life style, such as working a night shift, during the test period.
[14]Individuals who will develop seasonal allergy symptoms like hay fever.
[15]Individuals who are excessively negligent of skin care.
[16]Individuals who cannot avoid daylight exposure during the test period (including winter sports like ski and snowboard).
[17]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements in the past 3 months or will ingest those foods during the test period.
[18]Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months.
[19]Individuals who had been conducted an operation on the test spot.
[20]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months.
[21]Individuals who participated in other clinical studies in the past 3 months.
[22]Individuals who are or whose family is engaged in healthy or functional foods, or cosmetics.
[23]Individuals judged inappropriate for the study by the principal.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Shuji |
| Middle name | |
| Last name | Nakada |
Organization
Medical Corporation Bokushinkai CLINTEXE Clinic
Division name
Head
Zip code
105-6204
Address
4F Atago Green Hills Mori Tower 2-5-1 Atago Minato-ku Tokyo 105-6204, JAPAN
TEL
+81-3-5405-1059
info@tes-h.co.jp
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings Co., Ltd.
Division name
Administrative Department of Clinical Trials
Zip code
113-0033
Address
6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN
TEL
+81-3-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
HAYASHIBARA CO., 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
The Ethics Committee of the Oriental Ueno Detection Center, General Incorporated Association Oriental Occupational Health Association Tokyo Branch
Address
1-20-11 Ueno Taito-ku Tokyo 110-0005, JAPAN
Tel
+81-3-5816-0711
i.takahashi@tes-h.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
| 2018 | Year | 02 | Month | 15 | 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
40
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
| 2018 | Year | 01 | Month | 22 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 17 | Day |
Last follow-up date
| 2018 | Year | 04 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 13 | Day |
Last modified on
| 2019 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035442
