UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052879 |
|---|---|
| Receipt number | R000060338 |
| Scientific Title | Effects of a dairy ingredient on skin condition in healthy subjects: a randomized, double-blind, placebo-controlled trial. |
| Date of disclosure of the study information | 2023/11/23 |
| Last modified on | 2023/11/23 06:59:19 |
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Basic information
Public title
Effects of a dairy ingredient on skin condition in healthy subjects: a randomized, double-blind, placebo-controlled trial.
Acronym
Effects of a dairy ingredient on skin condition in healthy subjects.
Scientific Title
Effects of a dairy ingredient on skin condition in healthy subjects: a randomized, double-blind, placebo-controlled trial.
Scientific Title:Acronym
Effects of a dairy ingredient on skin condition in healthy subjects.
Region
| Japan |
Condition
Condition
None (Healthy subjects)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of a dairy ingredient on skin condition.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Index for skin conditions (Skin moisture content, Transepidermal water loss)
Key secondary outcomes
Feeling of dry skin.
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
Ingestion of dairy ingredient for 12 weeks.
Interventions/Control_2
Ingestion of placebo for 12 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
| 30 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Female
Key inclusion criteria
1)Healthy Japanese females aged 30-59 years.
2)Subjects who temporarily feel stressed due to work.
3)Subjects experiencing dry skin.
Key exclusion criteria
1)Subjects having a milk allergy.
2)Subjects whose lifestyle or living environment is possibly to change significantly during the study.
3)Subjects whose bedtime and/or waking time may change significantly during the study.
4)Subjects who are receiving invasive medical treatments or spa treatments impacting measured skin locations.
5)Subjects who have participated in other clinical trials within the past 3 months.
6)Subjects who are pregnant or under lactation, or who is expected to be pregnant during the study.
7)Subjects who have serious disease in the liver, kidney, heart, lung, gastrointestinal tract, blood, endocrine system, metabolic system, or have chronic disease etc. Or those who have serious medical history of these.
8)Subjects who have skin diseases, mental illness, a sleep disorder, or a medical history.
9)Subjects who needs to be on medication for allergic diseases such as pollinosis.
10)Smokers.
11)Extremely heavy drinkers (more than 60g/day of alcohol).
12)Subjects who use medicines or who habitually consume health-promoting foods.
13)Subjects who plan to engage in activities that affect skin condition at measured sites during the study.
14)Others who have been determined as ineligible for the research subject of this study, judging from the principal researcher/doctor's opinions on the findings of their background etc.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Koikeda |
Organization
Shiba Palace Clinic
Division name
Hospital director
Zip code
105-0013
Address
6F Daiwa A Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo
TEL
03-5408-1599
jimukyoku@mail.souken-r.com
Public contact
Name of contact person
| 1st name | Miwa |
| Middle name | |
| Last name | Kaneko |
Organization
SOUKEN Co., Ltd.
Division name
Secretariat
Zip code
105-0013
Address
3F Daiwa A Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo
TEL
03-5408-1555
Homepage URL
jimukyoku@mail.souken-r.com
Sponsor or person
Institute
SOUKEN Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry 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
Shiba Palace Clinic Ethics Review Committee
Address
6F Daiwa A 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 | 11 | Month | 23 | 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
| 2023 | Year | 10 | Month | 26 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 24 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 11 | Month | 23 | Day |
Last modified on
| 2023 | Year | 11 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060338
