- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01932281
SierraSil Joint Formula 14 as an Ergogenic Aid to Performance in Athletes
July 13, 2015 updated by: University of British Columbia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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British Columbia
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Vancouver, British Columbia, Canada, V6T 1Z3
- University of British Columbia
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- no contraindications to strenuous exercise
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SierraSil
SierraSil will be given in a dosage of 3 to 5, 667 mg capsules, according to body weight, daily for 3 weeks.
|
SierraSil is a natural, mineral supplement currently used to improve joint health and function.
|
Placebo Comparator: Placebo
This is a sugar pill and will be given in a dosage of 3 to 5 capsules daily for 3 weeks.
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Sugar pill manufactured to mimic SierraSil 667 mg capsule
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
change in total anaerobic capacity
Time Frame: change from baseline at 3 weeks
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change from baseline at 3 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Donald C. McKenzie, MD, PhD, University of British Columbia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2014
Primary Completion (Actual)
September 1, 2014
Study Completion (Actual)
September 1, 2014
Study Registration Dates
First Submitted
August 27, 2013
First Submitted That Met QC Criteria
August 29, 2013
First Posted (Estimate)
August 30, 2013
Study Record Updates
Last Update Posted (Estimate)
July 15, 2015
Last Update Submitted That Met QC Criteria
July 13, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H13-00121
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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