Effect of Nelutri™ on Musculoskeletal Biomarkers in Relative Sarcopenia Adults

Study Overview
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Brief Summary
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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
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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;

Official Title
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Effect of Nelutri™ on Musculoskeletal Biomarkers in Relative Sarcopenia Adults: a Randomized, Double-blinded, Placebo-controlled Trial

Conditions
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Muscular Sarcoidosis

Intervention / Treatment
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* Dietary Supplement: Nelutri™
* Dietary Supplement: Placebo group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nelutri™ group<br>This group takes Nelutri™ for 12 weeks | Dietary Supplement: Nelutri™<br>* Nelutri™ 2,000 mg/day for 12 weeks<br>|
| Placebo Comparator: Placebo group<br>This group takes placebo for 12 weeks | Dietary Supplement: Placebo group<br>* Placebo 2,000 mg/day for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| muscle strength | the peak torque at 60°/s knee extension (/kg) | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| appendicular skeletal mass/(height x height) | using dual-energy X-ray absorptiometry | 12 weeks | 
| appendicular skeletal mass/weight x 100 | using dual-energy X-ray absorptiometry | 12 weeks | 
| Skeletal Muscle Mass Index/(height x height) | using dual-energy X-ray absorptiometry | 12 weeks | 
| Creatinine Kinase | Creatinine Kinase | 12 weeks | 
| Lactate | Lactate | 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 | 12 weeks |