Effect of Nelutri™ on Musculoskeletal Biomarkers in Relative Sarcopenia Adults

Not Applicable

Completed

• Conditions: Muscular Sarcoidosis

• Registration Number: NCT04320121
• Lead Sponsor: Pusan National University Yangsan Hospital

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;

Study Timeline

• Study Start: 2020-03-11
• Study First Submitted: 2020-03-17
• Study First Submitted QC: 2020-03-21
• Study First Posted: 2020-03-24
• Primary Completion: 2020-12-30
• Study Completion: 2020-12-31
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-27
• Last Update Posted: 2021-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
muscle strength	12 weeks	the peak torque at 60°/s knee extension (/kg)

Secondary Outcome Measures

Name	Time	Method
appendicular skeletal mass/(height x height)	12 weeks	using dual-energy X-ray absorptiometry
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
Creatinine Kinase	12 weeks	Creatinine Kinase
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

Trial Locations

Locations (1)

Pusan National University Yangsan Hospital; 🇰🇷 Yangsan, Gyeungsangnam-do, Korea, Republic of