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OpenTrials
Completed

NCT Number: NCT03402308

Effect of Schisandra Chinensis Extract on Musculoskeletal Biomakers in Relatively Sarcopenic Adults: a RCT

The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of the SCE on muscle strength, muscle mass, and muscle function in healthy adults for 12 weeks.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pusan National University Yangsan Hospital

Pusan, Ami-dong, 602-739, South Korea

About this study

Previous studies have indicated that Schisandra chinensis extract (SCE) may have the ability to prevent skeletal muscle atrophy. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of the SCE 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 4 and 12 weeks of intervention. Fifty-four healthy adults were administered either 1,000 mg of SCE 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 InBody 720)
  • Body-mass index (BMI) ranging from 18.5 to 30.0 kg/m2

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 InBody 720)

Treatment and study plan

Schisandra chinensis extract

Dietary Supplement

Schisandra chinensis extract 1,000 mg/day for 12 weeks

Placebo

Dietary Supplement

Starch placebo 1,000 mg/day for 12 weeks

Primary outcomes

  1. muscle strength

    Time frame: 12 weeks

    the peak torque/body weight at 60°/s knee extension

Sponsors and collaborators

Lead sponsor

Pusan National University Yangsan Hospital

Other

Registry information

Official study title

Effect of Schisandra Chinensis Extract on Musculoskeletal Biomakers in Relatively Sarcopenic Adults: a Randomized, Double-blinded, Placebo-controlled Trial

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 18, 2018
Registry last updated
Apr 17, 2018

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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