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The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Nelutriâ„¢on muscle strength, muscle mass, and muscle function in healthy adults for 12 weeks.
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;
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nelutriâ„¢ group | Experimental | This group takes Nelutriâ„¢ for 12 weeks |
|
| Placebo group | Placebo Comparator | This group takes placebo for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nelutriâ„¢ | Dietary Supplement | Nelutriâ„¢ 2,000 mg/day for 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| muscle strength | the peak torque at 60°/s knee extension (/kg) | 12 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sang Yeoup Lee, MD | Pusan National University Yangsan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pusan National University Yangsan Hospital | Yangsan | Gyeungsangnam-do | 50612 | South Korea |
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| Placebo group |
| Dietary Supplement |
Placebo 2,000 mg/day for 12 weeks |
|
| 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 |