Effect of Nelutri™ on Musculoskeletal Biomarkers in Relative Sarcopenia Adults

Muscular Sarcoidosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04320121
• Other study ID #: 02-2020-005
• Status: Completed
• Phase: N/A
• Start date: March 11, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2021
• Source: Pusan National University Yangsan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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;

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 31, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Months and older

Eligibility

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

Related Conditions & MeSH terms

• Muscular Sarcoidosis
• Sarcoidosis
• Sarcopenia

Intervention

Dietary Supplement:
• Nelutri™
Nelutri™ 2,000 mg/day for 12 weeks
• Placebo group
Placebo 2,000 mg/day for 12 weeks

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan	Gyeungsangnam-do

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Yangsan Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	muscle strength	the peak torque at 60°/s knee extension (/kg)	12 weeks
Secondary	appendicular skeletal mass/(height x height)	using dual-energy X-ray absorptiometry	12 weeks
Secondary	appendicular skeletal mass/weight x 100	using dual-energy X-ray absorptiometry	12 weeks
Secondary	Skeletal Muscle Mass Index/(height x height)	using dual-energy X-ray absorptiometry	12 weeks
Secondary	Creatinine Kinase	Creatinine Kinase	12 weeks
Secondary	Lactate	Lactate	12 weeks
Secondary	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