EndogenousTestosterone Response to a Testosterone Boosting Supplement

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: Testosterone
• Intervention / Treatment: Dietary supplement: Testosterone boosting supplement; Dietary supplement: Placebo Comparator

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

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M2H 3J1
      • Canadian Memorial Chiropractic College

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	Change in concentration of salivary free testosterone from baseline to 4 weeks will be measured by ELISA	4 weeks

Collaborators and Investigators

• 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

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: Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Androgens; Testosterone
• Other Study ID Numbers: 151004