Back to resultsEffect of Schisandra Chinensis Extract on Musculoskeletal Biomakers in Relatively Sarcopenic Adults: a RCT
Primary Purpose
Muscular Sarcoidosis
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Schisandra chinensis extract
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Muscular Sarcoidosis
Eligibility Criteria
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)
Sites / Locations
- Pusan National University Yangsan Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Schisandra chinensis extract group
Placebo group
Arm Description
This group takes Schisandra chinensis extract for 12 weeks
This group takes placebo for 12 weeks
Outcomes
Primary Outcome Measures
muscle strength
the peak torque/body weight at 60°/s knee extension
Secondary Outcome Measures
Full Information
NCT ID
NCT03402308
First Posted
January 10, 2018
Last Updated
April 13, 2018
Sponsor
Pusan National University Yangsan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03402308
Brief Title
Effect of Schisandra Chinensis Extract on Musculoskeletal Biomakers in Relatively Sarcopenic Adults: a RCT
Official Title
Effect of Schisandra Chinensis Extract on Musculoskeletal Biomakers in Relatively Sarcopenic Adults: a Randomized, Double-blinded, Placebo-controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
March 1, 2018 (Actual)
Study Completion Date
March 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pusan National University Yangsan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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;
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscular Sarcoidosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Schisandra chinensis extract group
Arm Type
Experimental
Arm Description
This group takes Schisandra chinensis extract for 12 weeks
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
This group takes placebo for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Schisandra chinensis extract
Intervention Description
Schisandra chinensis extract 1,000 mg/day for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Starch placebo 1,000 mg/day for 12 weeks
Primary Outcome Measure Information:
Title
muscle strength
Description
the peak torque/body weight at 60°/s knee extension
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang Yeoup Lee, MD
Organizational Affiliation
Pusan National University Yangsan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pusan National University Yangsan Hospital
City
Pusan
State/Province
Ami-dong
ZIP/Postal Code
602-739
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33710261
Citation
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.
Results Reference
derived
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Effect of Schisandra Chinensis Extract on Musculoskeletal Biomakers in Relatively Sarcopenic Adults: a RCT
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