Muscular Sarcoidosis
Conditions
Brief 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.
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;
Interventions
DIETARY_SUPPLEMENTNelutri™
Nelutri™ 2,000 mg/day for 12 weeks
DIETARY_SUPPLEMENTPlacebo group
Placebo 2,000 mg/day for 12 weeks
Sponsors
Pusan National University Yangsan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Months to No maximum
Healthy volunteers
Yes
Inclusion criteria
* \<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.
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| muscle strength | 12 weeks | the peak torque at 60°/s knee extension (/kg) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| appendicular skeletal mass/weight x 100 | 12 weeks | using dual-energy X-ray absorptiometry |
| Skeletal Muscle Mass Index/(height x height) | 12 weeks | using dual-energy X-ray absorptiometry |
| appendicular skeletal mass/(height x height) | 12 weeks | using dual-energy X-ray absorptiometry |
| Lactate | 12 weeks | Lactate |
| EuroQol five dimensional three levels (EQ-5D-3L) | 12 weeks | an index of life quality, minimum, maximum values (-0.171, 1), higher scores mean a better outcome |
| Creatinine Kinase | 12 weeks | Creatinine Kinase |
Countries
South Korea
Outcome results
None listed