Unique ID issued by UMIN | UMIN000008382 |
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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 |
Nutritional supplementation and Electrical Muscle Stimulation in community-dwelling frail elderly Japanese
Nutritional supplementation and Electrical Muscle Stimulation in community-dwelling frail elderly Japanese
Nutritional supplementation and Electrical Muscle Stimulation in community-dwelling frail elderly Japanese
Nutritional supplementation and Electrical Muscle Stimulation in community-dwelling frail elderly Japanese
Japan |
Sarcopenia
Geriatrics |
Others
NO
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)
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.
Exploratory
Not applicable
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)
Muscle thickness and estimated muscle volume. body composition, gait speed, blood test between week 12 and baseline among three groups.
Interventional
Parallel
Randomized
Double blind -all involved are blinded
Placebo
3
Prevention
Food |
Exercise + Placebo
Exercise + Nutritional supplementation 1
Exercise + Nutritional supplementation 2
65 | years-old | <= |
90 | years-old | >= |
Male and Female
-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.
-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.
45
1st name | |
Middle name | |
Last name | Professor Toshio Moritani |
Laboratory of Applied Physiology
The Graduate School of Human & Environmental Studies
Kyoto University
The Graduate School of Human & Environmental Studies
Kyoto University, Sakyo-ku, Kyoto 606-8501
1st name | |
Middle name | |
Last name | Professor Toshio Moritani |
Kyoto University
The Graduate School of Human & Environmental Studies
Nestec Ltd
Nestec Ltd
Profit organization
NO
2012 | Year | 07 | Month | 09 | Day |
Unpublished
Terminated
2011 | Year | 09 | Month | 30 | Day |
2012 | Year | 07 | Month | 01 | Day |
2012 | Year | 10 | Month | 01 | Day |
2012 | Year | 07 | Month | 09 | Day |
2012 | Year | 10 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008855
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