Efficacy of Qualia Testosterone+ on Testosterone Levels in Adult Males (NCT07556458) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Efficacy of Qualia Testosterone+ on Testosterone Levels in Adult Males
75 participantsStarted 2026-04-08
Plain-language 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.
Who can participate
Age range28 Years – 65 Years
SexMALE
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Inclusion Criteria:
* 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
* Willing to complete questionnaires, records, and diaries associated with the study.
* Male participants aged 28-65
* A ≤500 ng/dL Total Testosterone at baseline
* Willing and able to visit a local blood draw facility for required blood sample collections
* Live within 20 miles of a suitable blood draw facility
* Willing to not consume any supplements containing Testosterone or botanicals known to impact hormones starting about 2 weeks prior to the baseline blood test and continuing through the intervention period.
Exclusion Criteria:
* 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
* On immunosuppressive therapy
* Individuals who were deemed incompatible with the test protocol
* Adults lacking capacity to consent
* Female
* Have Hypogonadism
* On Testosterone Replacement Therapy
* Taking Gonadotropin-releasing hormone …