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Efficacy of Qualia Testosterone+ on Testosterone Levels in Adult Males

NCT07556458 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2026-04-29

No results posted yet for this study

Summary

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.

Conditions

  • Low Testosterone Levels

Interventions

OTHER

Placebo

Matching placebo capsules. Participants take 3 capsules daily with breakfast for 28 days.

DIETARY_SUPPLEMENT

Qualia Testosterone+

Qualia Testosterone+ dietary supplement capsules (Formula 1 or Formula 2). Participants take 3 capsules daily with breakfast for 28 days. The supplement contains a proprietary blend of ingredients designed to support healthy testosterone levels.

Sponsors & Collaborators

  • Qualia Life Sciences

    lead INDUSTRY

Principal Investigators

  • Colin Gardner, PhD · Qualia Life Sciences, LLC

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
28 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-08
Primary Completion
2026-05-30
Completion
2026-06-03

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07556458 on ClinicalTrials.gov