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

Muscle Loss Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04229407
• Other study ID #: OEP-6CR003-401
• Status: Completed
• Phase: N/A
• Start date: March 12, 2018
• Est. completion date: October 7, 2020

Study information

• Verified date: April 2021
• Source: Orient Europharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 7, 2020
• Est. primary completion date: October 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Muscle Loss

Intervention

Dietary Supplement:
• Dietary supplement
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.
• vitamin B
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.

Locations

Country	Name	City	State
Taiwan	Veteran General Hospital-Taipei	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Orient Europharma Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Adverse events	Adverse events	12 weeks