NCT02600650

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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 19, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 9, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

November 9, 2015

Status Verified

November 1, 2015

Enrollment Period

7 months

First QC Date

August 19, 2015

Last Update Submit

November 6, 2015

Conditions

Testosterone

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

Testosterone boosting supplementDIETARY_SUPPLEMENT

Proprietary formulation of Testosterone boosting supplement administered daily

Experimental
Placebo ComparatorDIETARY_SUPPLEMENT

Daily administration of Placebo Comparator

Placebo

Eligibility Criteria

Age20 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Canadian Memorial Chiropractic College

Toronto, Ontario, M2H 3J1, Canada

Location

Study Officials

  • brian budgell, Ph.D.

    Canadian Memorial Chiropractic College

    PRINCIPAL INVESTIGATOR

Central Study Contacts

mark fillery, B.A.

CONTACT

+1 416 482-2340mfillery@cmcc.ca

brian budgell, Ph.D.

CONTACT

+1 416 482-2340bbudgell@cmcc.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 19, 2015

First Posted

November 9, 2015

Study Start

November 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

November 9, 2015

Record last verified: 2015-11

Locations

CA(1)