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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030491
Receipt No. R000034793
Scientific Title Effects of a Test Food for Skin Conditions
Date of disclosure of the study information 2018/01/09
Last modified on 2018/12/05

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Basic information
Public title Effects of a Test Food for Skin Conditions
Acronym Effects of a Test Food for Skin Conditions
Scientific Title Effects of a Test Food for Skin Conditions
Scientific Title:Acronym Effects of a Test Food for Skin Conditions
Region
Japan

Condition
Condition N/A ( healthy adault )
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to examine effects of a test food for skin conditions.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Indexes for skin conditions ( skin moisture content, transepidermal water loss, skin viscoelasticity )
0, 4 and 8 weeks after a test food intake
Key secondary outcomes VISIA ( 0, 4 and 8 weeks after a test food intake )
Subject's diary ( from the first day of ingestion of a test food to the last day of the test )

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
3 times per day for 8weeks
Interventions/Control_2 Oral ingestion of the placebo food
3 times per day for 8weeks
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
60 years-old >
Gender Male and Female
Key inclusion criteria 1) Japanese individuals aged 30-59 years.
2) Individuals who are healthy and are not suffered from a chronic malady including skin disease.
3) Individuals who are anxious abour skin dryness.
4) Individuals whose written informed consent has been obtained.
5) Individulals who can visit an inspection facility and be inspected in designated days.
6) 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 (especially gelatin, leg meat, pork) or other foods, and medical products.
9)Females who are or are possibly pregnant, or are lactating.
10)Males who shave with a razor.
11)Individuals who have an addiction to alcohol or a mental illness.
12)Individuals who are a smoker.
13)Individuals whose life style will change during the test period.
14)Individuals with probable seasonal allergy, such as pollinosis, during the test period.
15)Individuals who will get sunburned during the test period.
16)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.
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 conducted hormone replacement therapy in the past 3 months or have a history of conducting hormone replacement therapy.
20)Individuals who have received a cosmetic medicine in the past 6 months.
21)Individuals who were hospitalized and received treatment in the past 6 months.
22)Individuals who participated in other clinical studies in the past three months.
23)Individuals judged inappropriate for the study by the principal.
Target sample size 22

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Minoru Morita
Organization MORINAGA & CO., LTD.
Division name Health and Wellness Headquarters
Zip code
Address 2-1-1, SHIMOSUEYOSHI, TSURUMI-KU, YOKOHAMA
TEL 045-571-2982
Email m-morita-je@morinaga.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sadao Mori
Organization MORINAGA & CO., LTD.
Division name Health and Wellness Headquarters
Zip code
Address 2-1-1, SHIMOSUEYOSHI, TSURUMI-KU, YOKOHAMA
TEL 045-571-2982
Homepage URL
Email s-mori-ab@morinaga.co.jp

Sponsor
Institute MORINAGA & CO., LTD.
Institute
Department

Funding Source
Organization MORINAGA & 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
Address
Tel
Email

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 東京工科大学(東京都)

Other administrative information
Date of disclosure of the study information
2018 Year 01 Month 09 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2017 Year 12 Month 18 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 05 Day
Last follow-up date
2018 Year 04 Month 30 Day
Date of closure to data entry
2018 Year 04 Month 30 Day
Date trial data considered complete
2018 Year 04 Month 30 Day
Date analysis concluded
2018 Year 04 Month 30 Day

Other
Other related information

Management information
Registered date
2017 Year 12 Month 20 Day
Last modified on
2018 Year 12 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034793

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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