Muscle PowerNCT01932281
SierraSil Joint Formula 14 as an Ergogenic Aid to Performance in Athletes
A study testing SierraSil in people with Muscle Power and Muscle Fatigue, run by University of British Columbia at 1 site in Canada.
Trial summary
The purpose of this study is to examine whether supplementation with SierraSil can improve anaerobic power and reduce muscle fatigue in a group of well-trained athletes. A secondary purpose is to examine the effect of SierraSil on the severity of delayed onset muscle soreness. Read more about this study
- Who is it for?
- Ages 19 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Power, Muscle Fatigue
- What is being tested?
- SierraSil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- May 2014to Sep 2014
- Phase
- Interventional
- 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 19 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- no contraindications to strenuous exercise
Who cannot join
- muscle or joint injury
- taking any form of anti-inflammatory or pain medication
- females due to the variability that might be introduced due to the phases of the menstrual cycle
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia
Vancouver, British Columbia, V6T 1Z3
About this study
Official title: SierraSil as an Ergogenic Aid to Performance in Athletes
The purpose of this study is to examine whether supplementation with SierraSil can improve anaerobic power and reduce muscle fatigue in a group of well-trained athletes.
A secondary purpose is to examine the effect of SierraSil on the severity of delayed onset muscle soreness.
Read the detailed description
This is a double blind, crossover, pilot study that will examine the effect of SierraSil supplementation on the determinants of human performance. Anaerobic capacity, muscle fatigue, the severity of delayed onset muscle soreness (DOMS) and markers of inflammation will be measured before and after 3 weeks of supplementation with SierraSil or placebo. There will be a 3 week washout period prior to the crossover to ensure SierraSil supplementation has no residual effect.
- Conditions
- Muscle Power, Muscle Fatigue
- Being tested
- SierraSil, Placebo
- Keywords
- muscle power, muscle fatigue, SierraSil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SierraSilDietary supplement
SierraSil is a natural, mineral supplement currently used to improve joint health and function.
PlaceboDietary supplement
Sugar pill manufactured to mimic SierraSil 667 mg capsule
| Study group | Role | What they receive |
|---|---|---|
| SierraSil | Experimental | SierraSil will be given in a dosage of 3 to 5, 667 mg capsules, according to body weight, daily for 3 weeks. Receives: Dietary Supplement: SierraSil |
| Placebo | Placebo comparator | This is a sugar pill and will be given in a dosage of 3 to 5 capsules daily for 3 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in total anaerobic capacity
Measured: change from baseline at 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2013 (estimated)
- Study startMay 2014
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle PowerStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Donald C. McKenzie, MD, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01932281
- Sponsor's protocol ID
- H13-00121
- Status last verified
- Jul 2015
- First submitted
- 27 Aug 2013
- Last updated
- 15 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SierraSil as an Ergogenic Aid to Performance in Athletes
- ClinicalTrials.gov ID
- NCT01932281
- Acronym / sponsor ID
- H13-00121
- Conditions
- Muscle Power, Muscle Fatigue
- Keywords
- muscle power, muscle fatigue, SierraSil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 30 Aug 2013 (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.
The purpose of this study is to examine whether supplementation with SierraSil can improve anaerobic power and reduce muscle fatigue in a group of well-trained athletes.
A secondary purpose is to examine the effect of SierraSil on the severity of delayed onset muscle soreness.
Detailed description
This is a double blind, crossover, pilot study that will examine the effect of SierraSil supplementation on the determinants of human performance. Anaerobic capacity, muscle fatigue, the severity of delayed onset muscle soreness (DOMS) and markers of inflammation will be measured before and after 3 weeks of supplementation with SierraSil or placebo. There will be a 3 week washout period prior to the crossover to ensure SierraSil supplementation has no residual effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SierraSil | Experimental | Dietary Supplement: SierraSilSierraSil will be given in a dosage of 3 to 5, 667 mg capsules, according to body weight, daily for 3 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThis is a sugar pill and will be given in a dosage of 3 to 5 capsules daily for 3 weeks. |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- no contraindications to strenuous exercise
Key exclusion criteria (3 listed)
- muscle or joint injury
- taking any form of anti-inflammatory or pain medication
- females due to the variability that might be introduced due to the phases of the menstrual cycle
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 |
|---|---|---|
| SierraSilSierraSil is a natural, mineral supplement currently used to improve joint health and function. | Dietary supplement | SierraSil |
| PlaceboSugar pill manufactured to mimic SierraSil 667 mg capsule | Dietary supplement | Placebo |
Primary outcome
change in total anaerobic capacity
Time frame: change from baseline at 3 weeks
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 15 Jul 2015.
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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.
Donald C. McKenzie, MD, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SierraSil in people with Muscle Power and Muscle Fatigue, run by University of British Columbia at 1 site in Canada.
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 3 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 15 Jul 2015. 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 Canada. 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.
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 in total anaerobic capacity (time frame: change from baseline at 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jul 2015.