EndogenousTestosterone Response to a Testosterone Boostin... | NCT02600650

Studies
EndogenousTestosterone Response to a Testosterone Boosting Supplement

NCT02600650

Sponsor

Canadian Memorial Chiropractic College

Status

Unknown status

Last Update Posted

Nov 9, 2015Estimated

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Testosterone

Interventions

Testosterone boosting supplement
Placebo Comparator

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2015

Primary Completion Date

Jun 2016Estimated

Completion Date

Jun 2016Estimated

First Submitted Date

Aug 19, 2015

First Submission Date that Met QC Criteria

Nov 6, 2015

First Posted Date

Nov 9, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 6, 2015

Last Update Posted Date

Nov 9, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Brian Budgell, Professor, Canadian Memorial Chiropractic CollegePrincipal Investigator

Lead Sponsor

Canadian Memorial Chiropractic CollegeOTHER

Collaborators

Name	Class
Iovate Health Sciences International Inc	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental	Experimental	Receive daily authentic Testosterone boosting supplement	Dietary Supplement: Testosterone boosting supplement
Placebo	Placebo Comparator	Receive daily placebo supplementation	Dietary Supplement: Placebo Comparator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Testosterone boosting supplement	Dietary Supplement	Proprietary formulation of Testosterone boosting supplement administered daily	Experimental

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
mark fillery, B.A.	Contact	+1 416 482-2340	267	mfillery@cmcc.ca
brian budgell, Ph.D.	Contact	+1 416 482-2340	151	bbudgell@cmcc.ca

Overall Officials

Name	Affiliation	Role
brian budgell, Ph.D.	Canadian Memorial Chiropractic College	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Canadian Memorial Chiropractic College		Toronto	Ontario	M2H 3J1	Canada