UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027347 |
|---|---|
| Receipt number | 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 | 2020/05/18 09:30:57 |
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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
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
nomoto@eisei.or.jp
Sponsor or person
Institute
Minamino Hospital
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 10 | Day |
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
| 2020 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031293
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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