Clinical Trial to Assess the Preventive Effects of Cetylpyridinium Chloride on Sarcopenia

Early Phase 1

Completed

• Conditions: Sarcopenia
• Interventions: Drug: Cetylpyridinium Chloride (CPC); Drug: placebo

• Registration Number: NCT02575235
• Lead Sponsor: Seoul National University Hospital

Brief Summary

This study is to assess the impact on the prevention of sarcopenia after taking cetylpyridinium chloride targeting the patients of pre-sarcopenia or sarcopenia over the age of 60

Detailed Description

75 people that meet the inclusion criteria on screening test are assigned to one of three groups by randomization. They take the medication for four weeks under doubleblind. Two study groups take cetylpyridinium chloride of 1.5mg, 4.5mg daily for four weeks. Control group takes the placebo for the same period. The main outcome variables are measured and compared respectively in baseline, immediately after dosing end and two weeks, four weeks after the end of administration. Finally cetylpyridinium chloride is verified whether it has a preventive effect on sarcopenia and set an appropriate dose.

Study Timeline

• Study Start: 2015-10-01
• Study First Submitted: 2015-10-12
• Study First Submitted QC: 2015-10-13
• Study First Posted: 2015-10-14
• Primary Completion: 2016-07-01
• Study Completion: 2016-07-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-30
• Last Update Posted: 2021-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Pre-sarcopenia A. Reduced skeletal muscle mass (appendicular skeletal muscle mass/height2) M < 7.0kg/m2, F < 5.7kg/m2

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Exclusion Criteria

• History of stroke or spinal cord injury
• Artificial joint
• Acute disease or unstable chronic disease
• Phenylketonuria
• History of myocardiac infarction
• Allergic contact dermatitis
• History of drug/alcohol addiction, habitual smoker

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1.5mg Cetylpyridinium Chloride (CPC)	Cetylpyridinium Chloride (CPC)	1.5mg CPC will be taken daily for four weeks.
4.5mg Cetylpyridinium Chloride (CPC)	Cetylpyridinium Chloride (CPC)	4.5mg CPC will be taken daily for four weeks.
Control	placebo	Placebo will be taken daily for four weeks

Primary Outcome Measures

Name	Time	Method
Change from baseline in procollagen type III N-terminal peptide	baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration

Secondary Outcome Measures

Name	Time	Method
Change from baseline in transforming growth factor β1 (TGF-β1)	baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration
Change from baseline in insulin like growth factor 1 (IGF-1)	baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration
Change from baseline in Myostatin	baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration
Change from baseline in interleukin 1 (IL-1)	baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration
Change from baseline in fatty acid binding protein 3 (FABP3)	baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration
Change from baseline in monocyte chemoattractant protein 1 (MCP-1)	baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration
Change from baseline in Skeletal muscle index	baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration
Change from baseline in short physical performance battery (SPPB)	baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration
Change from baseline in tumor necrosis factor α (TNF-α)	baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration
Change from baseline in Grip strength	baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration

Trial Locations

Locations (1)

Seoul National University College of Medicine; 🇰🇷 Seoul, Korea, Republic of