UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008382
Receipt number 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 11:58:38

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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 or person

Institute

Nestec Ltd

Institute

Department

Personal name



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

Value
https://center6.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