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Clinical Trial to Assess the Preventive Effects of Cetylpyridinium Chloride on Sarcopenia (CPC2)

Primary Purpose

Sarcopenia

Status
Completed
Phase
Early Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cetylpyridinium Chloride (CPC)
placebo
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sarcopenia focused on measuring Sarcopenia, Cetylpyridinium chloride

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

1.5mg Cetylpyridinium Chloride (CPC)

4.5mg Cetylpyridinium Chloride (CPC)

Control

Arm Description

1.5mg CPC will be taken daily for four weeks.

4.5mg CPC will be taken daily for four weeks.

Placebo will be taken daily for four weeks

Outcomes

Primary Outcome Measures

Change from baseline in procollagen type III N-terminal peptide

Secondary Outcome Measures

Change from baseline in insulin like growth factor 1 (IGF-1)
Change from baseline in transforming growth factor β1 (TGF-β1)
Change from baseline in Myostatin
Change from baseline in tumor necrosis factor α (TNF-α)
Change from baseline in interleukin 1 (IL-1)
Change from baseline in fatty acid binding protein 3 (FABP3)
Change from baseline in monocyte chemoattractant protein 1 (MCP-1)
Change from baseline in Skeletal muscle index
Change from baseline in short physical performance battery (SPPB)
Change from baseline in Grip strength

Full Information

First Posted
October 12, 2015
Last Updated
September 30, 2021
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02575235
Brief Title
Clinical Trial to Assess the Preventive Effects of Cetylpyridinium Chloride on Sarcopenia
Acronym
CPC2
Official Title
Randomized, Double Blinded, Placebo-controlled Trial to Assess the Preventive Effects of Cetylpyridinium Chloride on Sarcopenia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2015 (Actual)
Primary Completion Date
July 1, 2016 (Actual)
Study Completion Date
July 1, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
Keywords
Sarcopenia, Cetylpyridinium chloride

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1.5mg Cetylpyridinium Chloride (CPC)
Arm Type
Experimental
Arm Description
1.5mg CPC will be taken daily for four weeks.
Arm Title
4.5mg Cetylpyridinium Chloride (CPC)
Arm Type
Experimental
Arm Description
4.5mg CPC will be taken daily for four weeks.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Placebo will be taken daily for four weeks
Intervention Type
Drug
Intervention Name(s)
Cetylpyridinium Chloride (CPC)
Intervention Description
Two study groups take CPC of 1.5mg and 4.5mg daily for four weeks.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Control group takes the placebo for the same period.
Primary Outcome Measure Information:
Title
Change from baseline in procollagen type III N-terminal peptide
Time Frame
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 Measure Information:
Title
Change from baseline in insulin like growth factor 1 (IGF-1)
Time Frame
baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration
Title
Change from baseline in transforming growth factor β1 (TGF-β1)
Time Frame
baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration
Title
Change from baseline in Myostatin
Time Frame
baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration
Title
Change from baseline in tumor necrosis factor α (TNF-α)
Time Frame
baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration
Title
Change from baseline in interleukin 1 (IL-1)
Time Frame
baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration
Title
Change from baseline in fatty acid binding protein 3 (FABP3)
Time Frame
baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration
Title
Change from baseline in monocyte chemoattractant protein 1 (MCP-1)
Time Frame
baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration
Title
Change from baseline in Skeletal muscle index
Time Frame
baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration
Title
Change from baseline in short physical performance battery (SPPB)
Time Frame
baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration
Title
Change from baseline in Grip strength
Time Frame
baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Seoul National University College of Medicine
City
Seoul
Country
Korea, Republic of

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

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