Efficacy of Qualia Testosterone+ on Testosterone Levels in Adult Males
ConditionLow Testosterone Levels
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age28-65
SponsorQualia Life Sciences
About this trial
This is a 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 assigned 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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Qualia Testosterone+
Dietary supplementQualia 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.
Placebo
Other interventionMatching placebo capsules. Participants take 3 capsules daily with breakfast for 28 days.
Treatment groups
75 Participants
are divided into 3 treatment groupsGroup A: Qualia Testosterone+ Formula 1Experimental treatment 1 intervention
Group B: Qualia Testosterone+ Formula 2Experimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Total Testosterone Levels
Between-group change in serum total testosterone concentration from baseline to Day 28, measured via venous blood draw analyzed by a CLIA-certified laboratory. Comparison across Qualia Testosterone+ Formula 1, Formula 2, and Placebo groups using linear mixed-effects models.
Time frame
Baseline and Day 28Secondary outcomes
1
Change in Free (Dialysis) Testosterone Levels
Between-group change in serum free testosterone concentration measured by equilibrium dialysis from baseline to Day 28, via venous blood draw analyzed by a CLIA-certified laboratory.
Time frame
Baseline and Day 282
Change in Aging Males' Symptoms (AMS) Scale Score
Between-group change in the Aging Males' Symptoms (AMS) Scale total score from baseline to Day 28. The AMS Scale is a validated 17-item self-reported questionnaire assessing symptoms associated with aging and declining testosterone in males.
Time frame
Baseline and Day 283
Change in PROMIS Fatigue 10a Score
Between-group change in the PROMIS Fatigue 10a short form T-score from baseline to Day 28. The PROMIS Fatigue 10a is a validated 10-item self-reported questionnaire measuring fatigue severity and its impact on daily functioning over the past 7 days.
Time frame
Baseline and Day 284
Safety and Tolerability
Within- and between-group changes from baseline to Days 14 and 28 in side effect profile using a custom Safety and Tolerability survey assessing symptoms including nausea, headache, mood changes, dizziness, bloating, itching, and sexual dysfunction.
Time frame
Baseline through Day 14 and Day 28Sponsors and contacts
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Source ClinicalTrials.gov