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Completed

NCT Number: NCT04229407

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

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

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Key information

Conditions

Muscle Loss Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Veteran General Hospital-Taipei

Taipei, 112, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Dietary Supplement

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.

Primary outcomes

  1. The proportion of subjects achieving clinically meaningful improvement in Increment ≥ 3% in bone-free lean body mass (unit: kilogram) at 12 weeks after baseline

    Time frame: 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.

  2. 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

    Time frame: 12 weeks

    The score is the total number of stands within 30 seconds.

  3. The proportion of subjects achieving clinically meaningful improvement in Increment ≥ 3% in strength of hand grip (unit: kilogram) at 12 weeks after baseline

    Time frame: 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 outcomes

  1. Mean change in bone-free lean body mass at 4 and 12 weeks after baseline

    Time frame: 12 weeks

    Bone-free lean body mass will be assessed by measured by dual- energy X-ray absorptiometry.

  2. Mean change in 30-sec chair stand test at 4 and 12 weeks after baseline

    Time frame: 12 weeks

    The score is the total number of stands within 30 seconds.

  3. Mean change in 6-meter walk test at 4 and 12 weeks after baseline

    Time frame: 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.

  4. Mean change in short physical performance battery (SPPB) score at 4 and 12 weeks after baseline

    Time frame: 12 weeks

    including Balance test, Gait speed test, Chair stand test

  5. Mean change in strength of hand grip at 4 and 12 weeks after baseline

    Time frame: 12 weeks

    Strength of hand grip will be assessed by Smedlay's DynamoMeter TTM Tokyo Japan.

  6. Mean change in intramuscular fat assessed by MRI at 12 weeks after baseline

    Time frame: 12 weeks

    Intramuscular fat will be assessed using the magnetic resonance images (MRI) at baseline and Week 12 for 32 subjects.

  7. Adverse events

    Time frame: 12 weeks

    Adverse events

Sponsors and collaborators

Lead sponsor

Orient Europharma Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 18, 2020
Registry last updated
Apr 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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