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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04229407
Recruitment Status : Recruiting
First Posted : January 18, 2020
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Muscle Loss Dietary Supplement: Dietary supplement Dietary Supplement: vitamin B Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: double blind
Primary Purpose: Treatment
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
Actual Study Start Date : March 12, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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

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.

Placebo Comparator: 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: 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04229407


Contacts
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Contact: Lee-Hsin Shaw, COM +886-2-27554881 ext 2567 lee-hsin.shaw@mail.oep.com.tw

Locations
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Taiwan
Veteran General Hospital-Taipei Recruiting
Taipei, Taiwan, 112
Contact: Chiang-Kung Chen, PHD         
Sponsors and Collaborators
Orient Europharma Co., Ltd.
Investigators
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Principal Investigator: Liang-Kung Chen, MD.PhD Taipei Veterans General Hospital, Taiwan

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Responsible Party: Orient Europharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT04229407    
Other Study ID Numbers: OEP-6CR003-401
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vitamins
Vitamin B Complex
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs