Effect of Fermented Oyster Extract on Musculoskeletal Biomarkers in Relative Sarcopenia Adults
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 fermented oyster extract 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 Sep 2019
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
September 25, 2019
CompletedFirst Submitted
Initial submission to the registry
September 27, 2019
CompletedFirst Posted
Study publicly available on registry
October 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 4, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedApril 26, 2022
April 1, 2022
7 months
September 27, 2019
April 23, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
muscle strength
the peak torque/body weight at 60°/s knee extension
12 weeks
Study Arms (2)
Fermented oyster extract group
EXPERIMENTALThis group takes fermented oyster extract for 12 weeks
Placebo group
PLACEBO COMPARATORThis group takes placebo for 12 weeks
Interventions
Fermented oyster extract 1,200 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pusan National University Yangsan Hospital
Yangsan, Gyeungsangnam-do, 50612, South Korea
Related Publications (1)
Lee YL, Lee SY. Effect of fermented oyster (Crassostrea gigas) extracts and regular walking on muscle strength and mass in older adults with relatively low muscle mass: A randomized controlled trial. Front Nutr. 2022 Jul 25;9:935395. doi: 10.3389/fnut.2022.935395. eCollection 2022.
PMID: 35958254DERIVED
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
- Professor
Study Record Dates
First Submitted
September 27, 2019
First Posted
October 1, 2019
Study Start
September 25, 2019
Primary Completion
May 4, 2020
Study Completion
December 31, 2020
Last Updated
April 26, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share