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SierraSil Joint Formula 14 as an Ergogenic Aid to Performance in Athletes

Primary Purpose

Muscle Power, Muscle Fatigue

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

SierraSil

Placebo

About this trial

This is an interventional treatment trial for Muscle Power focused on measuring muscle power, muscle fatigue, SierraSil

Eligibility Criteria

19 Years - 35 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

University of British Columbia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SierraSil

Placebo

Arm Description

SierraSil will be given in a dosage of 3 to 5, 667 mg capsules, according to body weight, daily for 3 weeks.

This is a sugar pill and will be given in a dosage of 3 to 5 capsules daily for 3 weeks.

Outcomes

Primary Outcome Measures

change in total anaerobic capacity

Secondary Outcome Measures

Full Information

NCT ID

NCT01932281

First Posted

August 27, 2013

Last Updated

July 13, 2015

Sponsor

University of British Columbia

1. Study Identification

Unique Protocol Identification Number

NCT01932281

Brief Title

SierraSil Joint Formula 14 as an Ergogenic Aid to Performance in Athletes

Official Title

SierraSil as an Ergogenic Aid to Performance in Athletes

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Completed

Study Start Date

May 2014 (undefined)

Primary Completion Date

September 2014 (Actual)

Study Completion Date

September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of British Columbia

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Muscle Power, Muscle Fatigue

Keywords

muscle power, muscle fatigue, SierraSil

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SierraSil

Arm Type

Experimental

Arm Description

SierraSil will be given in a dosage of 3 to 5, 667 mg capsules, according to body weight, daily for 3 weeks.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

This is a sugar pill and will be given in a dosage of 3 to 5 capsules daily for 3 weeks.

Intervention Type

Dietary Supplement

Intervention Name(s)

SierraSil

Intervention Description

SierraSil is a natural, mineral supplement currently used to improve joint health and function.

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

Sugar pill manufactured to mimic SierraSil 667 mg capsule

Primary Outcome Measure Information:

Title

change in total anaerobic capacity

Time Frame

change from baseline at 3 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Donald C. McKenzie, MD, PhD

Organizational Affiliation

University of British Columbia

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of British Columbia

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6T 1Z3

Country

Canada

12. IPD Sharing Statement

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SierraSil Joint Formula 14 as an Ergogenic Aid to Performance in Athletes

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