Muscle LossNCT04229407
Evaluate the Effect of Dietary Supplement on Muscle Mass and Physical Performance for Over 50 Years Old People
A study testing Dietary supplement and vitamin B in people with Muscle Loss, run by Orient Europharma Co., Ltd. at 1 site in Taiwan.
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 Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Muscle Loss
- What is being tested?
- Dietary supplement and vitamin B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 Mar 2018to 7 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
- Conditions
- Muscle Loss
- Being tested
- Dietary supplement, vitamin B
- Medical subject headings
- Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary supplementDietary 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 BDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Dietary supplement | Experimental | 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 Receives: Dietary Supplement: Dietary supplement |
| vitamin B | Placebo comparator | 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. Receives: Dietary Supplement: vitamin B |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
Secondary outcomes (7)
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
Adverse events
Adverse events
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start12 Mar 2018
- Primary completion7 Oct 2020
- Study completion7 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orient Europharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Liang-Kung Chen, MD.PhD, Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04229407
- Sponsor's protocol ID
- OEP-6CR003-401
- Status last verified
- Apr 2021
- First submitted
- 10 Apr 2018
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04229407
- Acronym / sponsor ID
- OEP-6CR003-401
- Conditions
- Muscle Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Orient Europharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Mar 2018 (actual)
- Primary completion
- 7 Oct 2020 (actual)
- Study completion
- 7 Oct 2020 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary supplement | Experimental | Dietary Supplement: Dietary supplementsubject 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 |
| vitamin B | Placebo comparator | Dietary Supplement: vitamin Bsubject 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary supplementMRI 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. | Dietary supplement | Dietary supplement |
| vitamin BMRI 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. | Dietary supplement | vitamin B |
Primary outcome
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.
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.
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.
7 secondary outcomes
Mean change in bone-free lean body mass at 4 and 12 weeks after baseline
Time frame: 12 weeks
Mean change in 30-sec chair stand test at 4 and 12 weeks after baseline
Time frame: 12 weeks
Mean change in 6-meter walk test at 4 and 12 weeks after baseline
Time frame: 12 weeks
Mean change in short physical performance battery (SPPB) score at 4 and 12 weeks after baseline
Time frame: 12 weeks
Mean change in strength of hand grip at 4 and 12 weeks after baseline
Time frame: 12 weeks
Mean change in intramuscular fat assessed by MRI at 12 weeks after baseline
Time frame: 12 weeks
Adverse events
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liang-Kung Chen, MD.PhD principal investigator
Taipei Veterans General Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary supplement and vitamin B in people with Muscle Loss, run by Orient Europharma Co., Ltd. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2021.