Preventive Effects of Cetylpyridinium Chloride on SarcopeniaStudy

Early Phase 1

Completed

• Conditions: Sarcopenia
• Interventions: Drug: cetylpyridinium chloride; Drug: Placebo

• Registration Number: NCT02297997
• 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 presarcopenia over the age of 60.

Detailed Description

65 people that meet the inclusion criteria on screening test are assigned to one of five groups by randomization. They take the medication for two weeks under double-blind. Four study groups take cetylpyridinium chloride of 1.5mg, 3mg, 4.5mg and 6mg daily for two 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 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: 2014-11-13
• Study First Submitted: 2014-11-19
• Study First Submitted QC: 2014-11-20
• Study First Posted: 2014-11-21
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-24
• Last Update Posted: 2021-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

• Presarcopenia A. Reduced skeletal muscle mass (ASM/height2) M < 7.0kg/m2, F < 5.7kg/m2 B. Normal grip strength M ≥ 26kg, F ≥ 18kg C. Normal physical performance Gait speed > 0.8m/s
• Community dwelling

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3mg Cetylpyridinium Chloride	cetylpyridinium chloride	Cetylpyridinium chloride of 3mg will be taken daily for two weeks.
Control	Placebo	Placebo will be taken daily for two weeks.
1.5mg Cetylpyridinium Chloride	cetylpyridinium chloride	Cetylpyridinium chloride of 1.5mg will be taken daily for two weeks.
4.5mg Cetylpyridinium Chloride	cetylpyridinium chloride	Cetylpyridinium chloride of 4.5mg will be taken daily for two weeks.
6mg Cetylpyridinium Chloride	cetylpyridinium chloride	Cetylpyridinium chloride of 6mg will be taken daily for two weeks.

Primary Outcome Measures

Name	Time	Method
Change from baseline in procollagen type III N-terminal peptide	baseline, immediately after dosing end, two weeks after the end of administration
Change from baseline in TNF-α	baseline, immediately after dosing end, two weeks after the end of administration
Change from baseline in IL-6	baseline, immediately after dosing end, two weeks after the end of administration
Change from baseline in myostatin	baseline, immediately after dosing end, two weeks after the end of administration
Change from baseline in urinary creatinine	baseline, immediately after dosing end, two weeks after the end of administration

Secondary Outcome Measures

Name	Time	Method
Change from baseline in Vitamin D	baseline, immediately after dosing end, two weeks after the end of administration
Change from baseline in CRP	baseline, immediately after dosing end, two weeks after the end of administration
Change from baseline in Hemoblobin	baseline, immediately after dosing end, two weeks after the end of administration
Change from baseline in Albumin	baseline, immediately after dosing end, two weeks after the end of administration