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

Not Applicable

Completed

• Conditions: Muscular Sarcoidosis
• Interventions: Dietary Supplement: Schisandra chinensis extract; Dietary Supplement: Placebo

• Registration Number: NCT03402308
• Lead Sponsor: Pusan National University Yangsan Hospital

Brief Summary

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.

Detailed Description

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;

Study Timeline

• Study Start: 2017-06-01
• Study First Submitted: 2018-01-10
• Study First Submitted QC: 2018-01-10
• Study First Posted: 2018-01-18
• Primary Completion: 2018-03-01
• Study Completion: 2018-03-01
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-13
• Last Update Posted: 2018-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Schisandra chinensis extract group	Schisandra chinensis extract	This group takes Schisandra chinensis extract for 12 weeks
Placebo group	Placebo	This group takes placebo for 12 weeks

Primary Outcome Measures

Name	Time	Method
muscle strength	12 weeks	the peak torque/body weight at 60°/s knee extension

Trial Locations

Locations (1)

Pusan National University Yangsan Hospital; 🇰🇷 Pusan, Ami-dong, Korea, Republic of