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

Muscular Sarcoidosis Clinical Trial

Official title:

Effect of Fermented Oyster Extract on Musculoskeletal Biomarkers in Relative Sarcopenia Adults: a Randomized, Double-blinded, Placebo-controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04109911
• Other study ID #: 02-2019-013
• Status: Completed
• Phase: N/A
• Start date: September 25, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2022
• Source: Pusan National University Yangsan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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;

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 31, 2020
• Est. primary completion date: May 4, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Muscular Sarcoidosis
• Sarcoidosis
• Sarcopenia

Intervention

Dietary Supplement:
• Fermented oyster extract
Fermented oyster extract 1,200 mg/day for 12 weeks
• Placebo
Placebo

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan	Gyeungsangnam-do

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Yangsan Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	muscle strength	the peak torque/body weight at 60°/s knee extension	12 weeks