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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027347
Receipt No. R000031293
Scientific Title The clinical evaluation of the frail skin improvement in elderly person effected by the Nutritional Supplement Drink(Containing Collagen Peptide, Vitamins, and Minerals) intake.
Date of disclosure of the study information 2017/05/15
Last modified on 2018/05/25

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Basic information
Public title The clinical evaluation of the frail skin improvement in elderly person effected by the Nutritional Supplement Drink(Containing Collagen Peptide, Vitamins, and Minerals) intake.
Acronym The clinical evaluation of the frail skin improvement in elderly person effected by the Nutritional Supplement Drink intake.
Scientific Title The clinical evaluation of the frail skin improvement in elderly person effected by the Nutritional Supplement Drink(Containing Collagen Peptide, Vitamins, and Minerals) intake.
Scientific Title:Acronym The clinical evaluation of the frail skin improvement in elderly person effected by the Nutritional Supplement Drink intake.
Region
Japan

Condition
Condition Skin function decline
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The study will be performed for the purpose of assessing the contribution of nutritional supplement drink containing the increased amount of micronutrients and collagen peptide to improve the condition of frail skin.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Skin elasticity
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Continue no treatment for 56 days
Interventions/Control_2 Take one bottle of the nutritional supplement drink every day for 56 days
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria -Inpatient who has taken 80% or more of supplied meals before the start of the study
Key exclusion criteria -Patient who has a skin disease that needs treatment or is immeasurable in the evaluation site
-Patient with chronic renal disease
-Patient using corticosteroids or receiving special skin care
-Patient who has developed aspiration pneumonia within one month
-Patient disqualified from participating in the Study by the doctor
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsuya Nomoto
Organization Minamino Hospital
Division name medical quality management department
Zip code
Address 5-30-3 minamino, Hachioji City, Tokyo
TEL 042-632-8118
Email nomoto@eisei.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuya Nomoto
Organization Minamino Hospital
Division name medical quality management department
Zip code
Address 5-30-3 minamino, Hachioji City, Tokyo
TEL 042-632-8118
Homepage URL
Email nomoto@eisei.or.jp

Sponsor
Institute Minamino Hospital
Institute
Department

Funding Source
Organization NUTRI Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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
2017 Year 05 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
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 05 Month 10 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 15 Day
Last follow-up date
2018 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 05 Month 15 Day
Last modified on
2018 Year 05 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031293

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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