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Clinical Trials in the USA / NCT07556458
Recruiting Not applicable

Efficacy of Qualia Testosterone+ on Testosterone Levels in Adult Males

NCT07556458 · tracked via the Priya Life Science USA tracker
Phase
Not applicable
Started
2026-05-19
Last updated
2026-10-05

Condition(s) studied

Low Testosterone Levels

Investigational drug(s) / intervention(s)

Qualia Testosterone+Placebo

Qualia Testosterone+: 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: Matching placebo capsules. Participants take 3 capsules daily with breakfast for 28 days.

Study summary

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.

Eligibility

Sex
MALE
Min age
28 Years
Max age
65 Years
Healthy volunteers
Accepted
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)

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Qualia Life Sciences Carlsbad California Recruiting

More Qualia Life Sciences trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07556458 on ClinicalTrials.gov ↗ ← All trials in the USA