Muscular SarcoidosisNCT04320121
Effect of Nelutri™ on Musculoskeletal Biomarkers in Relative Sarcopenia Adults
A study testing Nelutri™ in people with Muscular Sarcoidosis, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
Trial summary
The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Nelutri™on muscle strength, muscle mass, and muscle function in healthy adults for 12 weeks. Read more about this study
- Who is it for?
- Ages 19 months and olderHealthy volunteers can take part
- Conditions the study is for
- Muscular Sarcoidosis
- What is being tested?
- Nelutri™
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Mar 2020to 31 Dec 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 19 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- <110% of the standard lean body mass as measured using the body composition analyzer
- Body-mass index (BMI) ranging from 18.5 to 30.0 kg/m2
- Those who have an average protein intake of 60 g or more/day.
Who cannot join
- Abnormal liver or renal function (i.e., serum aminotransferase activity > 60 IU/L and serum creatinine concentrations > 1.2 mg/dL)
- Diabetes (diagnosed clinically or fasting glucose level > 126 mg/dL)
- History of fracture during the previous year
- Uncontrolled hypertension
- History of serious cardiac disease such as angina or myocardial infarction
- History of gastrectomy
Show all 9Show fewer
- History of medication for psychiatric disease
- Administration of oriental medicine including herbs within the past 4 weeks
- Evidence of relatively high skeletal mass (more than 110% of the standard lean body mass as measured using the body composition analyzer
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Pusan National University Yangsan Hospital
Yangsan, Gyeungsangnam-do, 50612
About this study
Official title: Effect of Nelutri™ on Musculoskeletal Biomarkers in Relative Sarcopenia Adults: a Randomized, Double-blinded, Placebo-controlled Trial
The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Nelutri™on muscle strength, muscle mass, and muscle function in healthy adults for 12 weeks.
Read the detailed description
A previous study has indicated that Nelutri™ may increase muscle mass and strength. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Nelutri™on muscle strength, muscle mass, and muscle function in healthy adults; the safety of the compound are also evaluate. The Investigators examine the peak torque/body weight at 60°/s knee extension, handgrip strength, skeletal muscle mass, physical performance, and metabolic parameters at baseline, as well as after 6 and 12 weeks of intervention. Eighty adults were administered either 2,000 mg of Nelutri™ or a placebo each day for 12 weeks;
- Conditions
- Muscular Sarcoidosis
- Being tested
- Nelutri™, Placebo group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nelutri™Dietary supplement
Nelutri™ 2,000 mg/day for 12 weeks
Placebo groupDietary supplement
Placebo 2,000 mg/day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Nelutri™ group | Experimental | This group takes Nelutri™ for 12 weeks Receives: Dietary Supplement: Nelutri™ |
| Placebo group | Placebo comparator | This group takes placebo for 12 weeks Receives: Dietary Supplement: Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle strength
the peak torque at 60°/s knee extension (/kg)
Measured: 12 weeks
Secondary outcomes (6)
appendicular skeletal mass/(height x height)
using dual-energy X-ray absorptiometry
Measured: 12 weeks
appendicular skeletal mass/weight x 100
using dual-energy X-ray absorptiometry
Measured: 12 weeks
Skeletal Muscle Mass Index/(height x height)
using dual-energy X-ray absorptiometry
Measured: 12 weeks
Creatinine Kinase
Creatinine Kinase
Measured: 12 weeks
Lactate
Lactate
Measured: 12 weeks
EuroQol five dimensional three levels (EQ-5D-3L)
an index of life quality, minimum, maximum values (-0.171, 1), higher scores mean a better outcome
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 posted24 Mar 2020
- Study start11 Mar 2020
- Primary completion30 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscular SarcoidosisStudies 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
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang Yeoup Lee, Pusan National University Yangsan Hospital
- Investigators
- Sang Yeoup Lee, MD, Principal investigator, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04320121
- Sponsor's protocol ID
- 02-2020-005
- Status last verified
- Apr 2021
- First submitted
- 17 Mar 2020
- Last updated
- 28 Apr 2021
- Results posted
- 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 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nelutri™ on Musculoskeletal Biomarkers in Relative Sarcopenia Adults: a Randomized, Double-blinded, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT04320121
- Acronym / sponsor ID
- 02-2020-005
- Conditions
- Muscular Sarcoidosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 11 Mar 2020 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 24 Mar 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.
The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Nelutri™on muscle strength, muscle mass, and muscle function in healthy adults for 12 weeks.
Detailed description
A previous study has indicated that Nelutri™ may increase muscle mass and strength. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Nelutri™on muscle strength, muscle mass, and muscle function in healthy adults; the safety of the compound are also evaluate. The Investigators examine the peak torque/body weight at 60°/s knee extension, handgrip strength, skeletal muscle mass, physical performance, and metabolic parameters at baseline, as well as after 6 and 12 weeks of intervention. Eighty adults were administered either 2,000 mg of Nelutri™ or a placebo each day for 12 weeks;
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 |
|---|---|---|
| Nelutri™ group | Experimental | Dietary Supplement: Nelutri™This group takes Nelutri™ for 12 weeks |
| Placebo group | Placebo comparator | Dietary Supplement: Placebo groupThis group takes placebo for 12 weeks |
Who may qualify
- Ages
- 19 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- <110% of the standard lean body mass as measured using the body composition analyzer
- Body-mass index (BMI) ranging from 18.5 to 30.0 kg/m2
- Those who have an average protein intake of 60 g or more/day.
Key exclusion criteria (9 listed)
- Abnormal liver or renal function (i.e., serum aminotransferase activity > 60 IU/L and serum creatinine concentrations > 1.2 mg/dL)
- Diabetes (diagnosed clinically or fasting glucose level > 126 mg/dL)
- History of fracture during the previous year
- Uncontrolled hypertension
- History of serious cardiac disease such as angina or myocardial infarction
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 |
|---|---|---|
| Nelutri™Nelutri™ 2,000 mg/day for 12 weeks | Dietary supplement | Nelutri™ group |
| Placebo groupPlacebo 2,000 mg/day for 12 weeks | Dietary supplement | Placebo group |
Primary outcome
muscle strength
Time frame: 12 weeks
the peak torque at 60°/s knee extension (/kg)
6 secondary outcomes
appendicular skeletal mass/(height x height)
Time frame: 12 weeks
appendicular skeletal mass/weight x 100
Time frame: 12 weeks
Skeletal Muscle Mass Index/(height x height)
Time frame: 12 weeks
Creatinine Kinase
Time frame: 12 weeks
Lactate
Time frame: 12 weeks
EuroQol five dimensional three levels (EQ-5D-3L)
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 28 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.
Sang Yeoup Lee, MD principal investigator
Pusan National University Yangsan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nelutri™ in people with Muscular Sarcoidosis, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. 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 28 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 South Korea. 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?
muscle strength (time frame: 12 weeks). 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 28 Apr 2021.