Clinical trial NCT02575235: Clinical Trial to Assess the Preventive Effects of Cetylpyridinium Chloride on Sarcopenia
Official title: Randomized, Double Blinded, Placebo-controlled Trial to Assess the Preventive Effects of Cetylpyridinium Chloride on Sarcopenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Sarcopenia
Keywords: Sarcopenia
Cetylpyridinium chloride
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2015-10-14
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

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

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

Primary outcomes:
measure: Change from baseline in procollagen type III N-terminal peptide
timeFrame: 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 outcomes:
measure: Change from baseline in insulin like growth factor 1 (IGF-1)
timeFrame: baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration
measure: Change from baseline in transforming growth factor β1 (TGF-β1)
timeFrame: baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration
measure: Change from baseline in Myostatin
timeFrame: baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration
measure: Change from baseline in tumor necrosis factor α (TNF-α)
timeFrame: baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration
measure: Change from baseline in interleukin 1 (IL-1)
timeFrame: baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration
measure: Change from baseline in fatty acid binding protein 3 (FABP3)
timeFrame: baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration
measure: Change from baseline in monocyte chemoattractant protein 1 (MCP-1)
timeFrame: baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration
measure: Change from baseline in Skeletal muscle index
timeFrame: baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration
measure: Change from baseline in short physical performance battery (SPPB)
timeFrame: baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration
measure: Change from baseline in Grip strength
timeFrame: baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University College of Medicine
Study officials:
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