EndogenousTestosterone Response to a Testosterone Boosting Supplement

Testosterone Clinical Trial

Official title:

EndogenousTestosterone Response to a Testosterone Boosting Supplement

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02600650
• Other study ID #: 151004
• Status: Not yet recruiting
• Phase: N/A
• First received: August 19, 2015
• Last updated: November 6, 2015
• Start date: November 2015
• Est. completion date: June 2016

Study information

• Verified date: November 2015
• Source: Canadian Memorial Chiropractic College
• Contact: mark fillery, B.A.
• Phone: +1 416 482-2340
• Email: mfillery[@]cmcc.ca
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Testosterone

Intervention

Dietary Supplement:
• Testosterone boosting supplement
Proprietary formulation of Testosterone boosting supplement administered daily
• Placebo Comparator
Daily administration of Placebo Comparator

Locations

Country	Name	City	State
Canada	Canadian Memorial Chiropractic College	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Canadian Memorial Chiropractic College	Iovate Health Sciences International Inc

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No