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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.
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 randomly assigned 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Qualia Testosterone+ Formula 1 | Experimental | Participants receive 3 capsules daily of Qualia Testosterone+ Formula 1 dietary supplement for 28 days. |
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| Qualia Testosterone+ Formula 2 | Experimental | Participants receive 3 capsules daily of Qualia Testosterone+ Formula 2 dietary supplement for 28 days. |
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| Placebo | Placebo Comparator | Participants receive 3 capsules daily of matching placebo for 28 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Qualia Testosterone+ | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Day 28 |
| Change in Aging Males' Symptoms (AMS) Scale Score |
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Inclusion Criteria:
Exclusion Criteria:
Male participants only. This study evaluates the effects of a dietary supplement on testosterone levels in adult males.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Colin Gardner, PhD | Contact | 678-387-7924 | colin@qualialife.com |
| Name | Affiliation | Role |
|---|---|---|
| Colin Gardner, PhD | Qualia Life Sciences, LLC | Principal Investigator |
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| Placebo | Other | Matching placebo capsules. Participants take 3 capsules daily with breakfast for 28 days. |
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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. |
| 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. | 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. | 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. | 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. | baseline to day 28 |