search
Back to results

Effect of Nelutri™ on Musculoskeletal Biomarkers in Relative Sarcopenia Adults

Primary Purpose

Muscular Sarcoidosis

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Nelutri™
Placebo group
Sponsored by
Pusan National University Yangsan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscular Sarcoidosis

Eligibility Criteria

19 Months - undefined (Child, Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Pusan National University Yangsan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nelutri™ group

Placebo group

Arm Description

This group takes Nelutri™ for 12 weeks

This group takes placebo for 12 weeks

Outcomes

Primary Outcome Measures

muscle strength
the peak torque at 60°/s knee extension (/kg)

Secondary Outcome Measures

appendicular skeletal mass/(height x height)
using dual-energy X-ray absorptiometry
appendicular skeletal mass/weight x 100
using dual-energy X-ray absorptiometry
Skeletal Muscle Mass Index/(height x height)
using dual-energy X-ray absorptiometry
Creatinine Kinase
Creatinine Kinase
Lactate
Lactate
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

Full Information

First Posted
March 17, 2020
Last Updated
April 27, 2021
Sponsor
Pusan National University Yangsan Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04320121
Brief Title
Effect of Nelutri™ on Musculoskeletal Biomarkers in Relative Sarcopenia Adults
Official Title
Effect of Nelutri™ on Musculoskeletal Biomarkers in Relative Sarcopenia Adults: a Randomized, Double-blinded, Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
March 11, 2020 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pusan National University Yangsan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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;

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscular Sarcoidosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nelutri™ group
Arm Type
Experimental
Arm Description
This group takes Nelutri™ for 12 weeks
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
This group takes placebo for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Nelutri™
Intervention Description
Nelutri™ 2,000 mg/day for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo group
Intervention Description
Placebo 2,000 mg/day for 12 weeks
Primary Outcome Measure Information:
Title
muscle strength
Description
the peak torque at 60°/s knee extension (/kg)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
appendicular skeletal mass/(height x height)
Description
using dual-energy X-ray absorptiometry
Time Frame
12 weeks
Title
appendicular skeletal mass/weight x 100
Description
using dual-energy X-ray absorptiometry
Time Frame
12 weeks
Title
Skeletal Muscle Mass Index/(height x height)
Description
using dual-energy X-ray absorptiometry
Time Frame
12 weeks
Title
Creatinine Kinase
Description
Creatinine Kinase
Time Frame
12 weeks
Title
Lactate
Description
Lactate
Time Frame
12 weeks
Title
EuroQol five dimensional three levels (EQ-5D-3L)
Description
an index of life quality, minimum, maximum values (-0.171, 1), higher scores mean a better outcome
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang Yeoup Lee, MD
Organizational Affiliation
Pusan National University Yangsan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
State/Province
Gyeungsangnam-do
ZIP/Postal Code
50612
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Nelutri™ on Musculoskeletal Biomarkers in Relative Sarcopenia Adults

We'll reach out to this number within 24 hrs