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

NCT ID: NCT03402308

Last Updated: 2018-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2018-03-01

Brief Summary

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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

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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;

Conditions

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Muscular Sarcoidosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Schisandra chinensis extract group

This group takes Schisandra chinensis extract for 12 weeks

Group Type EXPERIMENTAL

Schisandra chinensis extract

Intervention Type DIETARY_SUPPLEMENT

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

Placebo group

This group takes placebo for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Starch placebo 1,000 mg/day for 12 weeks

Interventions

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Schisandra chinensis extract

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

Starch placebo 1,000 mg/day for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pusan National University Yangsan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sang Yeoup Lee

Integrated Research Institute for Natural Ingredients and Functional Foods (IRINIF)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sang Yeoup Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Pusan National University Yangsan Hospital

Locations

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Pusan National University Yangsan Hospital

Pusan, Ami-dong, South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 33710261 (View on PubMed)

Other Identifiers

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02-2017-010

Identifier Type: -

Identifier Source: org_study_id

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