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Efficacy of Qualia Testosterone+ on Testosterone Levels in Adult Males

Sponsor: Qualia Life Sciences • ClinicalTrials.gov ID: NCT07556458

Registry updated: 2026-10-05

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Description

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.

Interventions

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.
Placebo (Other)
Matching placebo capsules. Participants take 3 capsules daily with breakfast for 28 days.

Eligibility criteria

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 (GnRH) injections or gonadotropins (hCG or FSH)

Conditions

Low Testosterone Levels

Locations

Qualia Life Sciences — Carlsbad, California, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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