Qualia Life Sciences
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 onc…
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…
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.
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