SarcopeniaEarly Phase 1CPC2NCT02575235
Clinical Trial to Assess the Preventive Effects of Cetylpyridinium Chloride on Sarcopenia
A Early Phase 1 study testing Cetylpyridinium Chloride (CPC) in people with Sarcopenia, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Cetylpyridinium Chloride (CPC)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Oct 2015to 1 Jul 2016
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pre-sarcopenia A. Reduced skeletal muscle mass (appendicular skeletal muscle mass/height2) M < 7.0kg/m2, F < 5.7kg/m2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double Blinded, Placebo-controlled Trial to Assess the Preventive Effects of Cetylpyridinium Chloride on Sarcopenia
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
Read the 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.
- Conditions
- Sarcopenia
- Being tested
- Cetylpyridinium Chloride (CPC), placebo
- Keywords
- Sarcopenia, Cetylpyridinium chloride
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cetylpyridinium Chloride (CPC)Drug
Two study groups take CPC of 1.5mg and 4.5mg daily for four weeks.
placeboDrug
Control group takes the placebo for the same period.
| Study group | Role | What they receive |
|---|---|---|
| 1.5mg Cetylpyridinium Chloride (CPC) | Experimental | 1.5mg CPC will be taken daily for four weeks. Receives: Drug: Cetylpyridinium Chloride (CPC) |
| 4.5mg Cetylpyridinium Chloride (CPC) | Experimental | 4.5mg CPC will be taken daily for four weeks. Receives: Drug: Cetylpyridinium Chloride (CPC) |
| Control | Placebo comparator | Placebo will be taken daily for four weeks Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in procollagen type III N-terminal peptide
Measured: 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 (10)
Change from baseline in insulin like growth factor 1 (IGF-1)
Measured: 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 transforming growth factor β1 (TGF-β1)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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
Measured: baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2015 (estimated)
- Study start1 Oct 2015
- Primary completion1 Jul 2016
- Study completion1 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sun Gun Chung, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02575235
- Sponsor's protocol ID
- SNUHRM-CPC2
- Acronym
- CPC2
- Status last verified
- Sep 2021
- First submitted
- 12 Oct 2015
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Pahor M, Manini T, Cesari M. Sarcopenia: clinical evaluation, biological markers and other evaluation tools. J Nutr Health Aging. 2009 Oct;13(8):724-8. doi: 10.1007/s12603-009-0204-9.
PubMed 19657557Janssen I, Heymsfield SB, Ross R. Low relative skeletal muscle mass (sarcopenia) in older persons is associated with functional impairment and physical disability. J Am Geriatr Soc. 2002 May;50(5):889-96. doi: 10.1046/j.1532-5415.2002.50216.x.
PubMed 12028177Hong S, Oh HJ, Choi H, Kim JG, Lim SK, Kim EK, Pyo EY, Oh K, Kim YT, Wilson K, Choi WH. Characteristics of body fat, body fat percentage and other body composition for Koreans from KNHANES IV. J Korean Med Sci. 2011 Dec;26(12):1599-605. doi: 10.3346/jkms.2011.26.12.1599. Epub 2011 Nov 29.
PubMed 22147997Kalyani RR, Corriere M, Ferrucci L. Age-related and disease-related muscle loss: the effect of diabetes, obesity, and other diseases. Lancet Diabetes Endocrinol. 2014 Oct;2(10):819-29. doi: 10.1016/S2213-8587(14)70034-8. Epub 2014 Mar 6.
PubMed 24731660Ormsbee MJ, Prado CM, Ilich JZ, Purcell S, Siervo M, Folsom A, Panton L. Osteosarcopenic obesity: the role of bone, muscle, and fat on health. J Cachexia Sarcopenia Muscle. 2014 Sep;5(3):183-92. doi: 10.1007/s13539-014-0146-x. Epub 2014 Apr 17.
PubMed 24740742Moller N, Vendelbo MH, Kampmann U, Christensen B, Madsen M, Norrelund H, Jorgensen JO. Growth hormone and protein metabolism. Clin Nutr. 2009 Dec;28(6):597-603. doi: 10.1016/j.clnu.2009.08.015. Epub 2009 Sep 20.
PubMed 19773097Miller MD, Crotty M, Giles LC, Bannerman E, Whitehead C, Cobiac L, Daniels LA, Andrews G. Corrected arm muscle area: an independent predictor of long-term mortality in community-dwelling older adults? J Am Geriatr Soc. 2002 Jul;50(7):1272-7. doi: 10.1046/j.1532-5415.2002.50316.x.
PubMed 12133024Enoki H, Kuzuya M, Masuda Y, Hirakawa Y, Iwata M, Hasegawa J, Izawa S, Iguchi A. Anthropometric measurements of mid-upper arm as a mortality predictor for community-dwelling Japanese elderly: the Nagoya Longitudinal Study of Frail Elderly (NLS-FE). Clin Nutr. 2007 Oct;26(5):597-604. doi: 10.1016/j.clnu.2007.06.008. Epub 2007 Jul 31.
PubMed 17669559Stephen WC, Janssen I. Sarcopenic-obesity and cardiovascular disease risk in the elderly. J Nutr Health Aging. 2009 May;13(5):460-6. doi: 10.1007/s12603-009-0084-z.
PubMed 19390754Rolland Y, Czerwinski S, Abellan Van Kan G, Morley JE, Cesari M, Onder G, Woo J, Baumgartner R, Pillard F, Boirie Y, Chumlea WM, Vellas B. Sarcopenia: its assessment, etiology, pathogenesis, consequences and future perspectives. J Nutr Health Aging. 2008 Aug-Sep;12(7):433-50. doi: 10.1007/BF02982704.
PubMed 18615225Landi F, Marzetti E, Martone AM, Bernabei R, Onder G. Exercise as a remedy for sarcopenia. Curr Opin Clin Nutr Metab Care. 2014 Jan;17(1):25-31. doi: 10.1097/MCO.0000000000000018.
PubMed 24310054Adamo ML, Farrar RP. Resistance training, and IGF involvement in the maintenance of muscle mass during the aging process. Ageing Res Rev. 2006 Aug;5(3):310-31. doi: 10.1016/j.arr.2006.05.001. Epub 2006 Sep 1.
PubMed 16949353Morley JE, Malmstrom TK. Frailty, sarcopenia, and hormones. Endocrinol Metab Clin North Am. 2013 Jun;42(2):391-405. doi: 10.1016/j.ecl.2013.02.006.
PubMed 23702408Dalton JT, Barnette KG, Bohl CE, Hancock ML, Rodriguez D, Dodson ST, Morton RA, Steiner MS. The selective androgen receptor modulator GTx-024 (enobosarm) improves lean body mass and physical function in healthy elderly men and postmenopausal women: results of a double-blind, placebo-controlled phase II trial. J Cachexia Sarcopenia Muscle. 2011 Sep;2(3):153-161. doi: 10.1007/s13539-011-0034-6. Epub 2011 Aug 2.
PubMed 22031847White HK, Petrie CD, Landschulz W, MacLean D, Taylor A, Lyles K, Wei JY, Hoffman AR, Salvatori R, Ettinger MP, Morey MC, Blackman MR, Merriam GR; Capromorelin Study Group. Effects of an oral growth hormone secretagogue in older adults. J Clin Endocrinol Metab. 2009 Apr;94(4):1198-206. doi: 10.1210/jc.2008-0632. Epub 2009 Jan 27.
PubMed 19174493
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double Blinded, Placebo-controlled Trial to Assess the Preventive Effects of Cetylpyridinium Chloride on Sarcopenia
- ClinicalTrials.gov ID
- NCT02575235
- Acronym / sponsor ID
- CPC2 / SNUHRM-CPC2
- Conditions
- Sarcopenia
- Keywords
- Sarcopenia, Cetylpyridinium chloride
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 1 Jul 2016 (actual)
- Study completion
- 1 Jul 2016 (actual)
- First posted
- 14 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1.5mg Cetylpyridinium Chloride (CPC) | Experimental | Drug: Cetylpyridinium Chloride (CPC)1.5mg CPC will be taken daily for four weeks. |
| 4.5mg Cetylpyridinium Chloride (CPC) | Experimental | Drug: Cetylpyridinium Chloride (CPC)4.5mg CPC will be taken daily for four weeks. |
| Control | Placebo comparator | Drug: placeboPlacebo will be taken daily for four weeks |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pre-sarcopenia A. Reduced skeletal muscle mass (appendicular skeletal muscle mass/height2) M < 7.0kg/m2, F < 5.7kg/m2
Key exclusion criteria (7 listed)
- History of stroke or spinal cord injury
- Artificial joint
- Acute disease or unstable chronic disease
- Phenylketonuria
- History of myocardiac infarction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cetylpyridinium Chloride (CPC)Two study groups take CPC of 1.5mg and 4.5mg daily for four weeks. | Drug | 1.5mg Cetylpyridinium Chloride (CPC), 4.5mg Cetylpyridinium Chloride (CPC) |
| placeboControl group takes the placebo for the same period. | Drug | Control |
Primary outcome
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
10 secondary outcomes
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
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
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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
- Background: PubMed 19657557Pahor M, Manini T, Cesari M. Sarcopenia: clinical evaluation, biological markers and other evaluation tools. J Nutr Health Aging. 2009 Oct;13(8):724-8. doi: 10.1007/s12603-009-0204-9.
- Background: PubMed 12028177Janssen I, Heymsfield SB, Ross R. Low relative skeletal muscle mass (sarcopenia) in older persons is associated with functional impairment and physical disability. J Am Geriatr Soc. 2002 May;50(5):889-96. doi: 10.1046/j.1532-5415.2002.50216.x.
- Background: PubMed 22147997Hong S, Oh HJ, Choi H, Kim JG, Lim SK, Kim EK, Pyo EY, Oh K, Kim YT, Wilson K, Choi WH. Characteristics of body fat, body fat percentage and other body composition for Koreans from KNHANES IV. J Korean Med Sci. 2011 Dec;26(12):1599-605. doi: 10.3346/jkms.2011.26.12.1599. Epub 2011 Nov 29.
- Background: PubMed 24731660Kalyani RR, Corriere M, Ferrucci L. Age-related and disease-related muscle loss: the effect of diabetes, obesity, and other diseases. Lancet Diabetes Endocrinol. 2014 Oct;2(10):819-29. doi: 10.1016/S2213-8587(14)70034-8. Epub 2014 Mar 6.
- Background: PubMed 24740742Ormsbee MJ, Prado CM, Ilich JZ, Purcell S, Siervo M, Folsom A, Panton L. Osteosarcopenic obesity: the role of bone, muscle, and fat on health. J Cachexia Sarcopenia Muscle. 2014 Sep;5(3):183-92. doi: 10.1007/s13539-014-0146-x. Epub 2014 Apr 17.
- Background: PubMed 19773097Moller N, Vendelbo MH, Kampmann U, Christensen B, Madsen M, Norrelund H, Jorgensen JO. Growth hormone and protein metabolism. Clin Nutr. 2009 Dec;28(6):597-603. doi: 10.1016/j.clnu.2009.08.015. Epub 2009 Sep 20.
- Background: PubMed 12133024Miller MD, Crotty M, Giles LC, Bannerman E, Whitehead C, Cobiac L, Daniels LA, Andrews G. Corrected arm muscle area: an independent predictor of long-term mortality in community-dwelling older adults? J Am Geriatr Soc. 2002 Jul;50(7):1272-7. doi: 10.1046/j.1532-5415.2002.50316.x.
- Background: PubMed 17669559Enoki H, Kuzuya M, Masuda Y, Hirakawa Y, Iwata M, Hasegawa J, Izawa S, Iguchi A. Anthropometric measurements of mid-upper arm as a mortality predictor for community-dwelling Japanese elderly: the Nagoya Longitudinal Study of Frail Elderly (NLS-FE). Clin Nutr. 2007 Oct;26(5):597-604. doi: 10.1016/j.clnu.2007.06.008. Epub 2007 Jul 31.
- Background: PubMed 19390754Stephen WC, Janssen I. Sarcopenic-obesity and cardiovascular disease risk in the elderly. J Nutr Health Aging. 2009 May;13(5):460-6. doi: 10.1007/s12603-009-0084-z.
- Background: PubMed 18615225Rolland Y, Czerwinski S, Abellan Van Kan G, Morley JE, Cesari M, Onder G, Woo J, Baumgartner R, Pillard F, Boirie Y, Chumlea WM, Vellas B. Sarcopenia: its assessment, etiology, pathogenesis, consequences and future perspectives. J Nutr Health Aging. 2008 Aug-Sep;12(7):433-50. doi: 10.1007/BF02982704.
- Background: PubMed 24310054Landi F, Marzetti E, Martone AM, Bernabei R, Onder G. Exercise as a remedy for sarcopenia. Curr Opin Clin Nutr Metab Care. 2014 Jan;17(1):25-31. doi: 10.1097/MCO.0000000000000018.
- Background: PubMed 16949353Adamo ML, Farrar RP. Resistance training, and IGF involvement in the maintenance of muscle mass during the aging process. Ageing Res Rev. 2006 Aug;5(3):310-31. doi: 10.1016/j.arr.2006.05.001. Epub 2006 Sep 1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Cetylpyridinium Chloride (CPC) in people with Sarcopenia, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02575235, which also lists 33 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2021.