NCT01932281

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 30, 2013

Completed
8 months until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

July 15, 2015

Status Verified

July 1, 2015

Enrollment Period

4 months

First QC Date

August 27, 2013

Last Update Submit

July 13, 2015

Conditions

Muscle PowerMuscle Fatigue

Keywords

muscle powermuscle fatigueSierraSil

Outcome Measures

Primary Outcomes (1)

  • change in total anaerobic capacity

    change from baseline at 3 weeks

Study Arms (2)

SierraSil

EXPERIMENTAL

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

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.

Dietary Supplement: Placebo

Interventions

SierraSilDIETARY_SUPPLEMENT

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

SierraSil
PlaceboDIETARY_SUPPLEMENT

Sugar pill manufactured to mimic SierraSil 667 mg capsule

Placebo

Eligibility Criteria

Age19 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • no contraindications to strenuous exercise

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, V6T 1Z3, Canada

Location

Study Officials

  • Donald C. McKenzie, MD, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2013

First Posted

August 30, 2013

Study Start

May 1, 2014

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

July 15, 2015

Record last verified: 2015-07

Locations

CA(1)