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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034563
Receipt No. 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 2018/10/18

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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
Middle name
Last name Noboru Makabe
Organization Kansai Electric Power Medical Research Institute
Division name Division of diabetes and endocrinology
Zip code
Address 2-1-7 Fukushima, Fukushima Ward, Osaka 5530003, Japan.
TEL 06-6458-5821
Email n-makabe@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noboru Makabe
Organization Kansai Electric Power Medical Research Institute
Division name Division of diabetes and endocrinology
Zip code
Address 2-1-7 Fukushima, Fukushima Ward, Osaka 5530003, Japan.
TEL 06-6458-5821
Homepage URL
Email n-makabe@umin.ac.jp

Sponsor
Institute Kansai Electric Power Hospital
Institute
Department

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
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
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 Enrolling by invitation
Date of protocol fixation
2018 Year 07 Month 13 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 01 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
2018 Year 10 Month 18 Day
Last modified on
2018 Year 10 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039395

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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