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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04109911
Recruitment Status : Completed
First Posted : October 1, 2019
Last Update Posted : April 26, 2022
Sponsor:
Information provided by (Responsible Party):
Sang Yeoup Lee, Pusan National University Yangsan Hospital

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.

Condition or disease Intervention/treatment Phase
Muscular Sarcoidosis Dietary Supplement: Fermented oyster extract Dietary Supplement: Placebo Not Applicable

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;

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Fermented Oyster Extract on Musculoskeletal Biomarkers in Relative Sarcopenia Adults: a Randomized, Double-blinded, Placebo-controlled Trial
Actual Study Start Date : September 25, 2019
Actual Primary Completion Date : May 4, 2020
Actual Study Completion Date : December 31, 2020

Arm Intervention/treatment
Experimental: Fermented oyster extract group
This group takes fermented oyster extract for 12 weeks
Dietary Supplement: Fermented oyster extract
Fermented oyster extract 1,200 mg/day for 12 weeks

Placebo Comparator: Placebo group
This group takes placebo for 12 weeks
Dietary Supplement: Placebo
Placebo




Primary Outcome Measures :
  1. muscle strength [ Time Frame: 12 weeks ]
    the peak torque/body weight at 60°/s knee extension



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04109911


Locations
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Korea, Republic of
Pusan National University Yangsan Hospital
Yangsan, Gyeungsangnam-do, Korea, Republic of, 50612
Sponsors and Collaborators
Pusan National University Yangsan Hospital
Investigators
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Principal Investigator: Sang Yeoup Lee, MD Pusan National University Yangsan Hospital
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Responsible Party: Sang Yeoup Lee, Professor, Pusan National University Yangsan Hospital
ClinicalTrials.gov Identifier: NCT04109911    
Other Study ID Numbers: 02-2019-013
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: April 26, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sarcopenia
Sarcoidosis
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Lymphoproliferative Disorders
Lymphatic Diseases