Clinical trial NCT04229407: Evaluate the Effect of Dietary Supplement on Muscle Mass and Physical Performance for Over 50 Years Old People
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Loss
Lead sponsor: Orient Europharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-01-18
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Main Inclusion Criteria:

1. Male or female aged 50 years or older.
2. 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
3. Willing to comply with study procedures and follow-ups
4. Provide written consent

Main Exclusion Criteria:

1. Gait speed ≤ 0.3 m/sec
2. Any disease that interferes with limb function, including:

   1. Limb fracture within past 6 months
   2. Severe knee, hip, or arm arthritis
   3. As judged by the investigator, disorder of nervous system (i.e., stroke, severe spinal stenosis, peripheral neuropathy, and Parkinson's disease) with poor control
   4. Intermittent claudication due to peripheral artery disease
3. As judged by the investigator, mental disorders (i.e., confirmed diagnosis of dementia) with poor control
4. Cardiopulmonary disease with poor control judged by the investigator
5. Malignancy with poor control judged by the investigator
6. Subjects claim to have chronic renal disease, defined as kidney damage or GFR \< 30 mL/min/1.73 m2 for at least 3 months
7. Severe visual and hearing impairment that becomes barrier to communication
8. 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
9. Subjects with known poorly controlled diabetes (HbA1c \> 9.0%), hyperthyroidism or thyroid insufficiency, Cushing's syndrome, or adrenal insufficiency
10. Subjects with known milk allergy or lactose intolerance
11. Other conditions that investigator considers subject is ineligible to participate in the study

Primary outcomes:
measure: The proportion of subjects achieving clinically meaningful improvement in Increment ≥ 3% in bone-free lean body mass (unit: kilogram) at 12 weeks after baseline
timeFrame: 12 weeks
measure: 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
timeFrame: 12 weeks
measure: The proportion of subjects achieving clinically meaningful improvement in Increment ≥ 3% in strength of hand grip (unit: kilogram) at 12 weeks after baseline
timeFrame: 12 weeks
Secondary outcomes:
measure: Mean change in bone-free lean body mass at 4 and 12 weeks after baseline
timeFrame: 12 weeks
measure: Mean change in 30-sec chair stand test at 4 and 12 weeks after baseline
timeFrame: 12 weeks
measure: Mean change in 6-meter walk test at 4 and 12 weeks after baseline
timeFrame: 12 weeks
measure: Mean change in short physical performance battery (SPPB) score at 4 and 12 weeks after baseline
timeFrame: 12 weeks
measure: Mean change in strength of hand grip at 4 and 12 weeks after baseline
timeFrame: 12 weeks
measure: Mean change in intramuscular fat assessed by MRI at 12 weeks after baseline
timeFrame: 12 weeks
measure: Adverse events
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Veteran General Hospital-Taipei
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Liang-Kung Chen, MD.PhD
role: PRINCIPAL_INVESTIGATOR
References: