Effect of Nelutri™ on Musculoskeletal Biomarkers in Relative Sarcopenia Adults

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

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.

Study Overview

• Status: Completed
• Conditions: Muscular Sarcoidosis
• Intervention / Treatment: Dietary supplement: Placebo group; Dietary supplement: Nelutri™

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeungsangnam-do
    • Yangsan, Gyeungsangnam-do, Korea, Republic of, 50612
      • Pusan National University Yangsan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo group; This group takes placebo for 12 weeks	Dietary supplement: Placebo group; Placebo 2,000 mg/day for 12 weeks
Experimental: Nelutri™ group; This group takes Nelutri™ for 12 weeks	Dietary supplement: Nelutri™; Nelutri™ 2,000 mg/day for 12 weeks

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pusan National University Yangsan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2020
• Primary Completion (Actual): December 30, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: March 17, 2020
• First Submitted That Met QC Criteria: March 21, 2020
• First Posted (Actual): March 24, 2020

Study Record Updates

• Last Update Posted (Actual): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia; Sarcoidosis
• Other Study ID Numbers: 02-2020-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No