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NCT Number: NCT07028255

Effectiveness of Qualia Testosterone Supplementation on Testosterone Levels

This is a randomized, double-blind, placebo-controlled parallel trial designed to assess the efficacy of Qualia Testosterone, a novel dietary supplement, in adult males aged 28 to 65 experiencing symptoms associated with testosterone deficiency. Approximately 60 participants will be randomized to receive either Qualia Testosterone (2 capsules daily) or a matched placebo for 21 days, with dosing administered each morning. The study's primary outcomes are changes in total testosterone, free testosterone (via dialysis), and dihydrotestosterone levels from baseline to Week 3. Secondary outcomes include changes in Aging Male Symptoms Scale scores-encompassing psychological, somatic, and sexual domains-as well as safety and tolerability. Blood samples will be collected in a laboratory setting, while symptom and safety assessments will be completed electronically at home.

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Key information

Conditions

Testosterone

Age range

28 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 score ≥27 on the Aging Males Symptom Scale 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 starting about 2 weeks prior to the baseline blood test test 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, or any other psychiatric or neurological medicines On immunosuppressive therapy Individuals who were deemed incompatible with the test protocol Adults lacking capacity to consent Have Hypogonadism

Treatment and study plan

Qualia Testosterone

Dietary Supplement

Qualia Testosterone manufactured by Qualia Life Sciences

Placebo

Dietary Supplement

Rice Flour

Primary outcomes

  1. Between-group change in blood testosterone levels

    Time frame: 3 weeks

    To assess the between-group differences in change from baseline to Week 3 in Total Testosterone, Free (Dialysis) Testosterone, and Dihydrotestosterone levels following Qualia Testosterone supplementation.

Secondary outcomes

  1. Aging Male Symptoms Scale scores

    Time frame: Week 3

    To evaluate between-group changes in Overall, Psychological, Somatic, and Sexual scores on the Aging Male Symptoms Scale from baseline to Week 3

  2. Side effect profile as measured by a custom Safety and Tolerability survey

    Time frame: Week 1, 2 and 3

    Number of participants with treatment-related adverse events as assessed by a score of 3 or greater on the Safety and Tolerability survey

Study contacts

Contact information is provided by the study sponsor or research team.

William Scuba

CONTACT

[email protected]

855-281-2328

Sponsors and collaborators

Lead sponsor

Qualia Life Sciences

Industry

Registry information

Official study title

Effectiveness of Qualia Testosterone Supplementation on Testosterone Levels: A Randomized Double-Blind Parallel Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 19, 2025
Registry last updated
Jun 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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