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

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

    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 1Z3
        • University of British Columbia

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.
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
change from baseline at 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

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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