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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000008382
Receipt No. R000008855
Scientific Title Nutritional supplementation and Electrical Muscle Stimulation in community-dwelling frail elderly Japanese
Date of disclosure of the study information 2012/07/09
Last modified on 2012/10/22

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Basic information
Public title Nutritional supplementation and Electrical Muscle Stimulation in community-dwelling frail elderly Japanese
Acronym Nutritional supplementation and Electrical Muscle Stimulation in community-dwelling frail elderly Japanese
Scientific Title Nutritional supplementation and Electrical Muscle Stimulation in community-dwelling frail elderly Japanese
Scientific Title:Acronym Nutritional supplementation and Electrical Muscle Stimulation in community-dwelling frail elderly Japanese
Region
Japan

Condition
Condition Sarcopenia
Classification by specialty
Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The primary objective is to demonstrate that the intake of a protein supplement in addition to electrical muscle stimulation will further improve muscle morphology (estimated change of the lower extremity muscle volume and muscle thickness of the quadriceps femoris, hamstrings muscle group, and triceps surae muscle by using ultrasonography of the individuals)
Basic objectives2 Others
Basic objectives -Others 1) Demonstrate that the intake of a blend of nutrients provided to third arm in addition to electrical muscle stimulation, will improve muscle thickness as compared with the individuals from the group receiving the protein supplement alone. Comparison group 3 vs group 2.
2) Demonstrate that the intake of the blend of nutrients provided to group 3 in addition to electrical muscle stimulation will improve muscle thickness of the individuals as compared with the group receiving only the placebo supplement. Comparison group 3 vs group 1.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The primary outcome will be the change of the muscle size between week 12 and baseline in group 2 as compared to the same difference observed in group 1, measured by ultrasonography (muscle thickness and estimated muscle volume)
Key secondary outcomes Muscle thickness and estimated muscle volume. body composition, gait speed, blood test between week 12 and baseline among three groups.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Exercise + Placebo
Interventions/Control_2 Exercise + Nutritional supplementation 1
Interventions/Control_3 Exercise + Nutritional supplementation 2
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
90 years-old >=
Gender Male and Female
Key inclusion criteria -Subject with gait speed between 0.6 and 1.2m/s
-Age: 65-90years (inclusive)
-Having obtained his/her (or his/her legal representative's) informed consent.
Key exclusion criteria -Subject submitted to regular exercise
-Obese subjects with BMI> 25kg/m2
-A history of neuromuscular problems.
-Subject who cannot be expected to comply with the study procedures for the whole duration of the study
-Currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study.
-Subject who currently takes or will take during the study other dietary supplements.
-Subject who was diagnosed severe disease such as chronic renal failure, liver cirrhosis, heart failure, active cancer and other major systemic diseases or any health impairment considered as clinically significant by the investigator before admission.
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Professor Toshio Moritani
Organization Laboratory of Applied Physiology
The Graduate School of Human & Environmental Studies
Kyoto University
Division name The Graduate School of Human & Environmental Studies
Zip code
Address Kyoto University, Sakyo-ku, Kyoto 606-8501
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Professor Toshio Moritani
Organization Kyoto University
Division name The Graduate School of Human & Environmental Studies
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Nestec Ltd
Institute
Department

Funding Source
Organization Nestec 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
2012 Year 07 Month 09 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 Terminated
Date of protocol fixation
2011 Year 09 Month 30 Day
Date of IRB
Anticipated trial start date
2012 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
2012 Year 10 Month 01 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 07 Month 09 Day
Last modified on
2012 Year 10 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008855

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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