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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029644
Receipt No. R000033866
Scientific Title Effect of Powdered food on a Condition of Skin in Healthy Adult Females.
Date of disclosure of the study information 2019/04/01
Last modified on 2017/10/20

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Basic information
Public title Effect of Powdered food on a Condition of Skin in Healthy Adult Females.
Acronym Effect of Powdered food on a Condition of Skin.
Scientific Title Effect of Powdered food on a Condition of Skin in Healthy Adult Females.
Scientific Title:Acronym Effect of Powdered food on a Condition of Skin.
Region
Japan

Condition
Condition To explore the effect of powdered food supplementation on skin.
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To explore the effect of powdered food supplementation on skin.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Measurement of skin condition. (measurement time: 0, 4, 8 weeks after intervention)
Key secondary outcomes Measurement of visual analog scale. (measurement time: 0, 4, 8 weeks after intervention)

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 Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Duration: 8weeks.
Test materials: Powdered food.
Does: 2 portions per day.
Interventions/Control_2 Duration: 8weeks.
Test materials: Powdered placebo food.
Does: 2 portions per day.
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
55 years-old <=
Age-upper limit
65 years-old >=
Gender Female
Key inclusion criteria 1.Healthy postmenopausal subjects from 55 to 65 years old.
2.BMI is >= 18.5 kg/m^2 and < 25.0 kg/m^2.
3.Subjects who concern with rough skin.
4.Subjects who keep regular daily life and sleep as possible.
5.Subjects who can visit the examination place on a fixed schedule.
6.Subjects who can cooperate with weight measurement, a questionnaire and skin measurement at the examination place.
7.Subjects who can intake test food dissolved with hot water etc., twice a day during the examination.
8.Subjects who can fill up the examination record everyday.
Key exclusion criteria 1.Subjects who have food allergy. Especially subjects who are sensitive to gelatin.
2.Subjects who have possibility of hay fever.
3.Subjects who have been medical history of physical disorder when they took supplements.
4.Subjects who are diabetes or hypercholesterolemia.
5.Subjects who take medicine and/or food for specified health use.
6.Subjects who took supplements and/or drink for improvement of skin condition within 1 month.
7.Subjects who smoke.
8.Subjects who had laser treatment and/or peeling treatment within 1 year.
9.Subjects who regularly have beauty treatment or plan to have beauty treatment.
10.Subjects who have possibility of excessive sunburn.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Inagaki, Hiroyuki
Organization MORINAGA & CO.,Ltd.
Division name Research Institute
Zip code
Address 2-1-1, Shimosueyoshi, Tsurumi-ku, Yokohama
TEL 045-571-2504
Email h-inagaki-jj@morinaga.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Inagaki, Hiroyuki
Organization MORINAGA & CO.,Ltd.
Division name Research Institute
Zip code
Address 2-1-1, Shimosueyoshi, Tsurumi-ku, Yokohama
TEL 045-571-2504
Homepage URL
Email h-inagaki-jj@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

Other administrative information
Date of disclosure of the study information
2019 Year 04 Month 01 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 Enrolling by invitation
Date of protocol fixation
2017 Year 09 Month 29 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 10 Month 20 Day
Last modified on
2017 Year 10 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033866

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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