Effect of Fermented Oyster Extract on Musculoskeletal Biomarkers in Relative Sarcopenia Adults

NCT ID: NCT04109911

Last Updated: 2022-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-25
• Study Completion Date: 2020-12-31

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.

Detailed Description

Previous studies have indicated that fermented oyster extract 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 fermented oyster extract 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 1,200 mg of fermented oyster extract or a placebo each day for 12 weeks;

Conditions

Muscular Sarcoidosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Fermented oyster extract group

This group takes fermented oyster extract for 12 weeks

Group Type: EXPERIMENTAL

Fermented oyster extract

Intervention Type: DIETARY_SUPPLEMENT

Fermented oyster extract 1,200 mg/day for 12 weeks

Placebo group

This group takes placebo for 12 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Interventions

Fermented oyster extract

Fermented oyster extract 1,200 mg/day for 12 weeks

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• <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

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pusan National University Yangsan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sang Yeoup Lee

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sang Yeoup Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Pusan National University Yangsan Hospital

Locations

Pusan National University Yangsan Hospital

Yangsan, Gyeungsangnam-do, South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 35958254 (View on PubMed)

Other Identifiers

02-2019-013

Identifier Type: -

Identifier Source: org_study_id