Effectiveness of Qualia Testosterone Supplementation on Testosterone Levels

NCT07028255 | Not Yet Recruiting

• 1 other identifier: QLS-013
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Testosterone

Keywords

testosterone supplementation; testosterone

Outcome Measures

Primary Outcomes (1)

• Between-group change in blood testosterone levels

  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.

  3 weeks

Secondary Outcomes (2)

• Aging Male Symptoms Scale scores

  Week 3

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

  Week 1, 2 and 3

Study Arms (2)

Qualia Testosterone

ACTIVE COMPARATOR

Qualia Testosterone manufactured by Qualia Life Sciences

Dietary Supplement: Qualia Testosterone

Placebo

PLACEBO COMPARATOR

Rice Flour

Dietary Supplement: Placebo

Interventions

Qualia Testosterone DIETARY_SUPPLEMENT

Qualia Testosterone manufactured by Qualia Life Sciences

Qualia Testosterone

Placebo DIETARY_SUPPLEMENT

Rice Flour

Placebo

Eligibility Criteria

• Age: 28 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Qualia Life Sciences: lead

Study Sites (1)

Qualia Life Sciences

Carlsbad, California, 92011, United States

Location

Central Study Contacts

William Scuba

CONTACT

855-281-2328; support@qualialife.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: June 19, 2025
• Study Start: July 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: October 1, 2025
• Last Updated: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)