Evaluate the Effect of Dietary Supplement on Muscle Mass and Physical Performance for Over 50 Years Old People

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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A Post-marketing, Double-blind, Placebo-controlled, Randomized, Parallel Study to Evaluate the Effect of Dietary Supplement on Muscle Mass and Physical Performance Among People Aged 50 Years and Older

Conditions
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Muscle Loss

Intervention / Treatment
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* Dietary Supplement: Dietary supplement
* Dietary Supplement: vitamin B


Participation Criteria
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Eligibility Criteria
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Main Inclusion Criteria: Male or female aged 50 years or older. Subjects who has muscle loss or at risk of muscle loss, with symptoms of reduced physical activities, reduced gait speed, exhaustion, or had tumbled/ fallen within past year Willing to comply with study procedures and follow-ups Provide written consent Main Exclusion Criteria: Gait speed ≤ 0.3 m/sec Any disease that interferes with limb function, including: Limb fracture within past 6 months Severe knee, hip, or arm arthritis As judged by the investigator, disorder of nervous system (i.e., stroke, severe spinal stenosis, peripheral neuropathy, and Parkinson's disease) with poor control Intermittent claudication due to peripheral artery disease As judged by the investigator, mental disorders (i.e., confirmed diagnosis of dementia) with poor control Cardiopulmonary disease with poor control judged by the investigator Malignancy with poor control judged by the investigator Subjects claim to have chronic renal disease, defined as kidney damage or GFR < 30 mL/min/1.73 m2 for at least 3 months Severe visual and hearing impairment that becomes barrier to communication Subjects have taken any hormone replacement therapy within 3 months prior to study enrollment, or plans to begin hormone replacement therapy at any time during the study Subjects with known poorly controlled diabetes (HbA1c > 9.0%), hyperthyroidism or thyroid insufficiency, Cushing's syndrome, or adrenal insufficiency Subjects with known milk allergy or lactose intolerance Other conditions that investigator considers subject is ineligible to participate in the study

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dietary supplement<br>subject will be evaluated for the eligibility of MRI assessment to assign subjects in randomization strata (MRI or non-MRI). After 32 subjects in MRI strata is reached. subjects will be randomized to intake Dietary supplement twice daily (every morning and night, 30 minutes after exercise if do exercise) for 12 weeks | Dietary Supplement: Dietary supplement<br>* 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.<br>|
| Placebo Comparator: vitamin B<br>subject will be evaluated for the eligibility of MRI assessment to assign subjects in randomization strata (MRI or non-MRI). After 32 subjects in MRI strata is reached. subjects will be randomized to intake placebo vitamin B twice daily (every morning and night, 30 minutes after exercise if do exercise) for 12 weeks. | Dietary Supplement: vitamin B<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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 | 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. | 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. | 12 weeks | 
| Adverse events | Adverse events | 12 weeks |