To assess the ability and safety profile of dietary supplement to augment lean body mass, muscle strength, and physical performance among people aged 50 years and older
In light of the rapidly expanding aging population, sarcopenia and related disorders are emerging as a major public health problem of the 21st century.Sponsor has produced a dietary supplement, which has been on market in Taiwan. The proposed study is conducted to confirm whether the amino acid supplementation is able to enhance the magnitude of gain in lean body mass and muscle strength in middle-aged and older adults with muscle loss or sarcopenia undergoing exercise training.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
80
MRI eligibility evaluation Dietary supplement drink powder dissolved in 150 c.c. warm water oral intake twice daily at every morning and night (30 minutes after exercise if do exercise) for 12 weeks subjects will be instructed to do 45-minute exercise once a week following the training program of the study trainer at gym, and 30-minute exercise (per exercise manual) at least twice a week at home.
MRI eligibility evaluation vitamin B drink powder dissolved in 150 c.c. warm water oral intake twice daily at every morning and night (30 minutes after exercise if do exercise)for 12 weeks subjects will be instructed to do 45-minute exercise once a week following the training program of the study trainer at gym, and 30-minute exercise (per exercise manual) at least twice a week at home.
Veteran General Hospital-Taipei
Taipei, Taiwan
The proportion of subjects achieving clinically meaningful improvement in Increment ≥ 3% in bone-free lean body mass (unit: kilogram) at 12 weeks after baseline
Bone-free lean body mass will be assessed by measured by dual- energy X-ray absorptiometry. An increment of ≥ 3% from baseline after 12 weeks of intervention will be regarded as clinically meaningful improvement.
Time frame: 12 weeks
The proportion of subjects achieving clinically meaningful improvement in Increment ≥ 3% in 30-sec chair stand test (unit: number of stand) at 12 weeks after baseline
The score is the total number of stands within 30 seconds.
Time frame: 12 weeks
The proportion of subjects achieving clinically meaningful improvement in Increment ≥ 3% in strength of hand grip (unit: kilogram) at 12 weeks after baseline
Strength of hand grip will be assessed by Smedlay's DynamoMeter TTM Tokyo Japan. An increment of ≥ 3% from baseline after 12 weeks of intervention will be regarded as clinically meaningful improvement.
Time frame: 12 weeks
Mean change in bone-free lean body mass at 4 and 12 weeks after baseline
Bone-free lean body mass will be assessed by measured by dual- energy X-ray absorptiometry.
Time frame: 12 weeks
Mean change in 30-sec chair stand test at 4 and 12 weeks after baseline
The score is the total number of stands within 30 seconds.
Time frame: 12 weeks
Mean change in 6-meter walk test at 4 and 12 weeks after baseline
The 6MWT measures the walking speed an individual is able to walk over a total of six meters on a hard, flat surface at their usual pace.
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Time frame: 12 weeks
Mean change in short physical performance battery (SPPB) score at 4 and 12 weeks after baseline
including Balance test, Gait speed test, Chair stand test
Time frame: 12 weeks
Mean change in strength of hand grip at 4 and 12 weeks after baseline
Strength of hand grip will be assessed by Smedlay's DynamoMeter TTM Tokyo Japan.
Time frame: 12 weeks
Mean change in intramuscular fat assessed by MRI at 12 weeks after baseline
Intramuscular fat will be assessed using the magnetic resonance images (MRI) at baseline and Week 12 for 32 subjects.
Time frame: 12 weeks
Adverse events
Adverse events
Time frame: 12 weeks