UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031293