UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034563 |
|---|---|
| Receipt number | R000039395 |
| Scientific Title | Research for nutrition therapy in prevention of skin-tear |
| Date of disclosure of the study information | 2018/10/18 |
| Last modified on | 2022/10/21 11:42:20 |
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Basic information
Public title
Research for nutrition therapy in prevention of skin-tear
Acronym
Research for nutrition therapy in prevention of skin-tear
Scientific Title
Research for nutrition therapy in prevention of skin-tear
Scientific Title:Acronym
Research for nutrition therapy in prevention of skin-tear
Region
| Japan |
Condition
Condition
skin-tear
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to inspect the effects of collagen peptide and antioxidant substance, and develop the nutrition therapy for skin-tear prevention.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Variations of skin horny cell layer moisture and viscoelasticity in 2 months.
Key secondary outcomes
1)Nutritional intake.
2)Nutritional status changes assessing with body weight and MNA-short Form.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intervention group : energy 25-35kcal/kg BW/day, protein 1.2g/kg BW/day, and 125ml drink, containing 10g of collagen peptide, once a day for two months.
Interventions/Control_2
Control group : energy 25-35kcal/kg BW/day, protein 1.2g/kg BW/day, 125ml non collagen peptide drink once a day for two months.
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Elderly person over 65 years of age.
(2)Subject who is possible to be assessed once a month.
Key exclusion criteria
(1)Using external medicine including moisturizing agent at measurement site.
(2)Using steroid.
(3)Critical liver or renal dysfunction.
(4)Heart failure under limited physical activity ; New York Heart Association class II,III,IV.
(5)Severe infection or trauma.
(6)Using a pacemaker or implantable defibrillator.
(7)Allergy to fruits.
(8)Judgment of inappropriate for this study by attending doctor or principal investigator.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Noboru |
| Middle name | |
| Last name | Makabe |
Organization
Kansai Electric Power Medical Research Institute
Division name
Division of diabetes and endocrinology
Zip code
5530-0003
Address
2-1-7 Fukushima, Fukushima Ward, Osaka 5530003, Japan.
TEL
06-6458-5821
n-makabe@umin.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Koga |
Organization
Kansai Electric Power Medical Research Institute
Division name
secretariat
Zip code
553-0003
Address
2-1-7 Fukushima, Fukushima Ward, Osaka 5530003, Japan.
TEL
06-6458-5821
Homepage URL
koga.kazuhiro@c3.kepco.co.jp
Sponsor or person
Institute
Kansai Electric Power Hospital
Institute
Department
Personal name
Funding Source
Organization
NUTRI 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
Kansai Electric Power Medical Research Institute
Address
2-1-7 Fukushima, Fukushima Ward, Osaka 5530003, Japan.
Tel
06-6458-5821
koga.kazuhiro@c3.kepco.co.jp
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
| 2018 | Year | 10 | Month | 18 | 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
| 2018 | Year | 07 | Month | 13 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 13 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2022 | 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
| 2018 | Year | 10 | Month | 18 | Day |
Last modified on
| 2022 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039395
