Effect of Nelutri™ on Musculoskeletal Biomarkers in Relative Sarcopenia Adults
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 11, 2020
CompletedFirst Submitted
Initial submission to the registry
March 17, 2020
CompletedFirst Posted
Study publicly available on registry
March 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedApril 28, 2021
April 1, 2021
10 months
March 17, 2020
April 27, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
muscle strength
the peak torque at 60°/s knee extension (/kg)
12 weeks
Secondary Outcomes (6)
appendicular skeletal mass/(height x height)
12 weeks
appendicular skeletal mass/weight x 100
12 weeks
Skeletal Muscle Mass Index/(height x height)
12 weeks
Creatinine Kinase
12 weeks
Lactate
12 weeks
- +1 more secondary outcomes
Study Arms (2)
Nelutri™ group
EXPERIMENTALThis group takes Nelutri™ for 12 weeks
Placebo group
PLACEBO COMPARATORThis group takes placebo for 12 weeks
Interventions
Eligibility Criteria
You may qualify if:
- \<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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pusan National University Yangsan Hospital
Yangsan, Gyeungsangnam-do, 50612, South Korea
Study Officials
- PRINCIPAL INVESTIGATOR
Sang Yeoup Lee, MD
Pusan National University Yangsan Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 17, 2020
First Posted
March 24, 2020
Study Start
March 11, 2020
Primary Completion
December 30, 2020
Study Completion
December 31, 2020
Last Updated
April 28, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share