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

Not Applicable

Completed

• Conditions: Muscle Loss
• Interventions: Dietary Supplement: vitamin B; Dietary Supplement: Dietary supplement

• Registration Number: NCT04229407
• Lead Sponsor: Orient Europharma Co., Ltd.

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.

Study Timeline

• Study Start: 2018-03-12
• Study First Submitted: 2018-04-10
• Study First Submitted QC: 2020-01-12
• Study First Posted: 2020-01-18
• Primary Completion: 2020-10-07
• Study Completion: 2020-10-07
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-29
• Last Update Posted: 2021-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vitamin B	vitamin B	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	Dietary supplement	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

Primary Outcome Measures

Name	Time	Method
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	12 weeks	The score is the total number of stands within 30 seconds.
The proportion of subjects achieving clinically meaningful improvement in Increment ≥ 3% in bone-free lean body mass (unit: kilogram) at 12 weeks after baseline	12 weeks	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.
The proportion of subjects achieving clinically meaningful improvement in Increment ≥ 3% in strength of hand grip (unit: kilogram) at 12 weeks after baseline	12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Mean change in short physical performance battery (SPPB) score at 4 and 12 weeks after baseline	12 weeks	including Balance test, Gait speed test, Chair stand test
Mean change in bone-free lean body mass at 4 and 12 weeks after baseline	12 weeks	Bone-free lean body mass will be assessed by measured by dual- energy X-ray absorptiometry.
Adverse events	12 weeks	Adverse events
Mean change in strength of hand grip at 4 and 12 weeks after baseline	12 weeks	Strength of hand grip will be assessed by Smedlay's DynamoMeter TTM Tokyo Japan.
Mean change in 30-sec chair stand test at 4 and 12 weeks after baseline	12 weeks	The score is the total number of stands within 30 seconds.
Mean change in 6-meter walk test at 4 and 12 weeks after baseline	12 weeks	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.
Mean change in intramuscular fat assessed by MRI at 12 weeks after baseline	12 weeks	Intramuscular fat will be assessed using the magnetic resonance images (MRI) at baseline and Week 12 for 32 subjects.

Trial Locations

Locations (1)

Veteran General Hospital-Taipei; 🇨🇳 Taipei, Taiwan