EndogenousTestosterone Response to a Testosterone Boosting Supplement

November 6, 2015 updated by: Brian Budgell, Canadian Memorial Chiropractic College
The purpose of this study is to determine whether a proprietary 'testosterone-boosting' supplement, when used as recommended by the manufacturer, results in an increase in testosterone levels as measured by a salivary free testosterone assay.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The experimental intervention in this study is the daily administration of a testosterone boosting supplement or sham supplement for 4 weeks. The supplement will be administered daily in capsule form. The control group will be given a sham capsule containing the carrier components of the supplement. Participants will be asked not to modify their current lifestyle. Salivary testosterone levels will be assessed prior to the intervention to collect a baseline measurement for each subject, and following the intervention to evaluate any changes in hormone levels.

Study Type

Interventional

Enrollment (Anticipated)

60

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 Contact

  • Name: mark fillery, B.A.
  • Phone Number: 267 +1 416 482-2340
  • Email: mfillery@cmcc.ca

Study Contact Backup

  • Name: brian budgell, Ph.D.
  • Phone Number: 151 +1 416 482-2340
  • Email: bbudgell@cmcc.ca

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M2H 3J1
        • Canadian Memorial Chiropractic College
        • Contact:
        • Contact:
          • brian budgell, Ph.D.
          • Phone Number: 151 +1 416 482-2340
          • Email: bbudgell@cmcc.ca
        • Principal Investigator:
          • brian budgell, Ph.D.

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

20 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Adult male aged 20 to 40 years.
  • Fluent in English.

Exclusion Criteria:

  • Currently receiving hormonal therapy or testosterone boosting supplement.
  • Has received hormonal therapy or testosterone boosting supplement within 3 months prior to study.
  • Has experienced adverse event following previous exposure to testosterone boosting supplements.

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
Receive daily authentic Testosterone boosting supplement
Dietary supplement: Testosterone boosting supplement
Proprietary formulation of Testosterone boosting supplement administered daily
Placebo Comparator: Placebo
Receive daily placebo supplementation
Dietary supplement: Placebo Comparator
Daily administration of Placebo Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in concentration of salivary free testosterone from baseline measured by ELISA
Time Frame: 4 weeks
Change in concentration of salivary free testosterone from baseline to 4 weeks will be measured by ELISA
4 weeks

Collaborators and Investigators

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

Sponsor

Canadian Memorial Chiropractic College

Collaborators

Iovate Health Sciences International Inc

Investigators

  • Principal Investigator: brian budgell, Ph.D., Canadian Memorial Chiropractic College

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

November 1, 2015

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

August 19, 2015

First Submitted That Met QC Criteria

November 6, 2015

First Posted (Estimate)

November 9, 2015

Study Record Updates

Last Update Posted (Estimate)

November 9, 2015

Last Update Submitted That Met QC Criteria

November 6, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 151004

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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