Efficacy of Qualia Testosterone+ on Testosterone Levels in Adult Males

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age28-65
SponsorQualia Life Sciences

About this trial

This is a randomized, double-blind, placebo-controlled, triple-arm, parallel-group study evaluating the efficacy and tolerability of two distinct Qualia Testosterone+ formulations, novel dietary supplements formulated to support endogenous testosterone, in adult males aged 28-65. Approximately 75 participants will be randomized equally to receive Qualia Testosterone+ Formula 1, Qualia Testosterone+ Formula 2, or a matched placebo (3 capsules once each morning) for 28 days. The primary outcome is between-group change in total testosterone from baseline to day 28. Secondary outcomes include changes in free (dialysis) testosterone, the Aging Male Symptoms Scale, the PROMIS Short Form v1.0 - Fatigue 10a, and safety and tolerability assessments. Blood samples will be collected in a clinical laboratory setting, while symptom and safety assessments will be completed electronically at home.

Eligibility criteria

Qualifiers

Provide voluntary, written, informed consent to participate in the study

Agree to provide a valid cell phone number and are willing to receive communications through text

Can read and write English

Willing to not begin taking any new supplements during the study and continue taking any supplements they are currently using regularly

Disqualifiers

Known food intolerances/allergy to any ingredients in the product

Having any of the following conditions: Psychiatric conditions, neurologic disorders, endocrine disorders, cancer

Having had a significant cardiovascular event in the past 6 months

Taking MAO inhibitors, SSRIs, blood thinners, or any other psychiatric or neurological medicines

Trial design

Treatments tested in this trial

  • Qualia Testosterone+
  • Placebo

Treatment groups

75 Participants
are divided into 3 treatment groups

Locations

This trial has no locations

Sponsors and collaborators