Effect of Schisandra Chinensis Extract on Musculoskeletal Biomakers in Relatively Sarcopenic Adults: a RCT
1 other identifier
interventional
54
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2017
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
June 1, 2017
CompletedFirst Submitted
Initial submission to the registry
January 10, 2018
CompletedFirst Posted
Study publicly available on registry
January 18, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedApril 17, 2018
April 1, 2018
9 months
January 10, 2018
April 13, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
muscle strength
the peak torque/body weight at 60°/s knee extension
12 weeks
Study Arms (2)
Schisandra chinensis extract group
EXPERIMENTALThis group takes Schisandra chinensis extract for 12 weeks
Placebo group
PLACEBO COMPARATORThis group takes placebo for 12 weeks
Interventions
Schisandra chinensis extract 1,000 mg/day for 12 weeks
Eligibility Criteria
You may qualify if:
- \<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
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 InBody 720)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pusan National University Yangsan Hospital
Pusan, Ami-dong, 602-739, South Korea
Related Publications (1)
Cho YH, Lee SY, Lee CH, Park JH, So YS. Effect of Schisandra chinensis Baillon extracts and regular low-intensity exercise on muscle strength and mass in older adults: a randomized, double-blind, placebo-controlled trial. Am J Clin Nutr. 2021 Jun 1;113(6):1440-1446. doi: 10.1093/ajcn/nqaa447.
PMID: 33710261DERIVED
MeSH Terms
Interventions
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
- Integrated Research Institute for Natural Ingredients and Functional Foods (IRINIF)
Study Record Dates
First Submitted
January 10, 2018
First Posted
January 18, 2018
Study Start
June 1, 2017
Primary Completion
March 1, 2018
Study Completion
March 1, 2018
Last Updated
April 17, 2018
Record last verified: 2018-04