Recruiting

Qualia Testosterone+

Sponsor:

Qualia Life Sciences

Code:

NCT07556458

Conditions

Low Testosterone Levels

Eligibility Criteria

Sex: Male

Age: 28 - 65

Healthy Volunteers: Accepted

Interventions

Qualia Testosterone+

Placebo

Study Details

Brief 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.

Conditions

Low Testosterone Levels

Study ID

NCT07556458

Start date

May 19, 2026

Status verified date

Oct, 2026

Completion date

Nov, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 28 - 65

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)

Study Design

Enrollment

75 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Qualia Testosterone+ Formula 1

Participants receive 3 capsules daily of Qualia Testosterone+ Formula 1 dietary supplement for 28 days.

experimental: Qualia Testosterone+ Formula 2

Participants receive 3 capsules daily of Qualia Testosterone+ Formula 2 dietary supplement for 28 days.

placebo comparator: Placebo

Participants receive 3 capsules daily of matching placebo for 28 days.

Interventions

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.

Primary outcome measure

  • Change in Total Testosterone Levels [ Time Frame: Baseline and Day 28 ]

Central Contacts and Locations

Central contacts

Colin Gardner, PhD

678-387-7924colin@qualialife.com

Locations

Qualia Life Sciences

Recruiting

Carlsbad, California, United States, 92008

More Information

Sponsor

Qualia Life Sciences

Last update posted

Oct 5, 2026

Last verified

Oct, 2026

Keywords

  • Testosterone
  • Dietary Supplement
  • Male Vitality

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-06. This information was provided to ClinicalTrials.gov by Qualia Life Sciences on 2026-10-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.