Effect of Nelutri™ on Musculoskeletal Biomarkers in Relative Sarcopenia Adults

Pusan National University Yangsan Hospital

Status: Completed

Conditions: Muscular Sarcoidosis

Treatments: Dietary Supplement: Placebo group; Dietary Supplement: Nelutri™

Study type: Interventional

Funder types: Other

Identifiers

NCT04320121

02-2020-005

Details and patient eligibility

About

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.

Full 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;

Enrollment: 80 patients

Sex: All

Ages: 19+ months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups, including a placebo group

Nelutri™ group

Experimental group

Description:

This group takes Nelutri™ for 12 weeks

Treatment:

Dietary Supplement: Nelutri™

Placebo group

Placebo Comparator group

Description:

This group takes placebo for 12 weeks

Treatment:

Dietary Supplement: Placebo group