An interventional study of Qualia Testosterone+ and Placebo in Low Testosterone Levels, sponsored by Qualia Life Sciences. Recruiting at 1 site in United States. Open to male participants aged 28 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by Qualia Life Sciences · Not applicable, Interventional, and Other
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.
Participants will be screened using the Aging Male Symptoms (AMS) Scale and the Androgen Deficiency in the Aging Male (ADAM) questionnaire to select candidates likely to have sub-optimal testosterone levels. Those meeting inclusion criteria will have total testosterone tested, and participants with baseline total testosterone of 500 ng/dL or less will be stratified and assigned using systematic allocation to one of three groups in a 1:1:1 ratio: Qualia Testosterone+ Formula 1, Qualia Testosterone+ Formula 2, or matched placebo.
Each participant will take 3 capsules of the assigned product once daily in the morning for 28 consecutive days. The placebo consists of vegetable/cellulose capsules containing inert rice powder, matched to the active capsules in appearance.
Blood samples for total and free testosterone (equilibrium dialysis) will be collected at baseline and day 26-28 at Ulta-affiliated phlebotomy sites, with morning collection recommended. Symptom questionnaires (AMS Scale, PROMIS Fatigue 10a, Safety and Tolerability survey) will be completed electronically at baseline, day 14, and day 28. A follow-up questionnaire will be completed at day 32-34. Regular check-in surveys will assess adherence and safety on days 1, 3, 7, 14, 21, and 28.
Statistical analyses will include paired t-tests or linear mixed-effects models for within-group differences, and linear mixed-effects models with fixed effects for group, time, and their interaction for between-group comparisons. The sample size was estimated to yield 80% power to detect an effect size of Cohen's d = 0.80 with a two-tailed t-test at a 0.05 significance level.
Note on allocation (added September 2026): Participants were assigned to study arms by systematic allocation rather than by random allocation. Earlier versions of this record described the design as randomized. The Allocation field and the design descriptions were corrected to Non-Randomized to reflect the method actually used. No other aspect of the study design, conduct, or analysis changed.
Qualia Life Sciences is the lead sponsor of 14 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive 3 capsules daily of Qualia Testosterone+ Formula 1 dietary supplement for 28 days.
Dietary Supplement: Qualia Testosterone+
Participants receive 3 capsules daily of Qualia Testosterone+ Formula 2 dietary supplement for 28 days.
Dietary Supplement: Qualia Testosterone+
Participants receive 3 capsules daily of matching placebo for 28 days.
Other: Placebo
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.
Matching placebo capsules. Participants take 3 capsules daily with breakfast for 28 days.
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 28
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 28
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 28
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 28
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 28
Within group difference in total testosterone
To assess within-group differences from baseline to day 28 in Total Testosterone following Qualia Testosterone and Placebo supplementation.
Time frame: Baseline to 28 days
Within-group differences in Free (Dialysis) Testosterone
To assess within-group differences from baseline to day 28 in Free (Dialysis) Testosterone following Qualia Testosterone and Placebo supplementation.
Time frame: baseline to day 28
Plan to share: No
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for Nov 2026, 6 months after the start.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 5, 2026: start Apr 2026 → May 2026, primary completion May 2026 → Nov 2026 and completion Jun 2026 → Nov 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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