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Completed

NCT Number: NCT04320121

Effect of Nelutri™ on Musculoskeletal Biomarkers in Relative Sarcopenia Adults

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.

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Key information

Age range

19 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pusan National University Yangsan Hospital

Yangsan, Gyeungsangnam-do, 50612, South Korea

About this study

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;

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nelutri™

Dietary Supplement

Nelutri™ 2,000 mg/day for 12 weeks

Placebo Group

Dietary Supplement

Placebo 2,000 mg/day for 12 weeks

Primary outcomes

  1. muscle strength

    Time frame: 12 weeks

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

Secondary outcomes

  1. appendicular skeletal mass/(height x height)

    Time frame: 12 weeks

    using dual-energy X-ray absorptiometry

  2. appendicular skeletal mass/weight x 100

    Time frame: 12 weeks

    using dual-energy X-ray absorptiometry

  3. Skeletal Muscle Mass Index/(height x height)

    Time frame: 12 weeks

    using dual-energy X-ray absorptiometry

  4. Creatinine Kinase

    Time frame: 12 weeks

    Creatinine Kinase

  5. Lactate

    Time frame: 12 weeks

    Lactate

  6. EuroQol five dimensional three levels (EQ-5D-3L)

    Time frame: 12 weeks

    an index of life quality, minimum, maximum values (-0.171, 1), higher scores mean a better outcome

Sponsors and collaborators

Lead sponsor

Pusan National University Yangsan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 24, 2020
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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