Sarcopenia
Conditions
Keywords
sarcopenia, cetylpyridinium chloride
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.
Interventions
Four study groups take cetylpyridinium chloride of 1.5mg, 3mg, 4.5mg and 6mg daily for two weeks.
DRUGPlacebo
Control group takes the placebo for the same period.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in urinary creatinine | baseline, immediately after dosing end, two weeks after the end of administration |
| 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 myostatin | 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
Outcome results
None listed