Low Testosterone LevelsNCT07556458
Efficacy of Qualia Testosterone+ on Testosterone Levels in Adult Males
A study testing Qualia Testosterone+ in people with Low Testosterone Levels, run by Qualia Life Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 28 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Low Testosterone Levels
- What is being tested?
- Qualia Testosterone+
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2026to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
Show all 11Show fewer
- Adults lacking capacity to consent
- Female
- Have Hypogonadism
- On Testosterone Replacement Therapy
- Taking Gonadotropin-releasing hormone (GnRH) injections or gonadotropins (hCG or FSH)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Qualia Life Sciences
Carlsbad, California, 92008
About this study
Official title: The Efficacy of Qualia Testosterone+ on Testosterone Levels: A Triple-Armed Placebo-Controlled Parallel Study
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.
Read the detailed description
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 once daily in the morning for 28 consecutive days. The placebo consists of vegetable/cellulose capsules containing inert rice powder, matched to the active capsules in appearance.
Blood samples for total and free testosterone (equilibrium dialysis) will be collected at baseline and day 26-28 at Ulta-affiliated phlebotomy sites, with morning collection recommended. Symptom questionnaires (AMS Scale, PROMIS Fatigue 10a, Safety and Tolerability survey) will be completed electronically at baseline, day 14, and day 28. A follow-up questionnaire will be completed at day 32-34. Regular check-in surveys will assess adherence and safety on days 1, 3, 7, 14, 21, and 28.
Statistical analyses will include paired t-tests or linear mixed-effects models for within-group differences, and linear mixed-effects models with fixed effects for group, time, and their interaction for between-group comparisons. The sample size was estimated to yield 80% power to detect an effect size of Cohen's d = 0.80 with a two-tailed t-test at a 0.05 significance level.
Note on allocation (added September 2026): Participants were assigned to study arms by systematic allocation rather than by random allocation. Earlier versions of this record described the design as randomized. The Allocation field and the design descriptions were corrected to Non-Randomized to reflect the method actually used. No other aspect of the study design, conduct, or analysis changed.
- Conditions
- Low Testosterone Levels
- Being tested
- Qualia Testosterone+, Placebo
- Keywords
- Testosterone, Dietary Supplement, Male Vitality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualia Testosterone+Dietary supplement
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.
PlaceboOther
Matching placebo capsules. Participants take 3 capsules daily with breakfast for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Qualia Testosterone+ Formula 1 | Experimental | Participants receive 3 capsules daily of Qualia Testosterone+ Formula 1 dietary supplement for 28 days. Receives: Dietary Supplement: Qualia Testosterone+ |
| Qualia Testosterone+ Formula 2 | Experimental | Participants receive 3 capsules daily of Qualia Testosterone+ Formula 2 dietary supplement for 28 days. Receives: Dietary Supplement: Qualia Testosterone+ |
| Placebo | Placebo comparator | Participants receive 3 capsules daily of matching placebo for 28 days. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Testosterone Levels
Between-group change in serum total testosterone concentration from baseline to Day 28, measured via venous blood draw analyzed by a CLIA-certified laboratory. Comparison across Qualia Testosterone+ Formula 1, Formula 2, and Placebo groups using linear mixed-effects models.
Measured: Baseline and Day 28
Secondary outcomes (6)
Change in Free (Dialysis) Testosterone Levels
Between-group change in serum free testosterone concentration measured by equilibrium dialysis from baseline to Day 28, via venous blood draw analyzed by a CLIA-certified laboratory.
Measured: Baseline and Day 28
Change in Aging Males' Symptoms (AMS) Scale Score
Between-group change in the Aging Males' Symptoms (AMS) Scale total score from baseline to Day 28. The AMS Scale is a validated 17-item self-reported questionnaire assessing symptoms associated with aging and declining testosterone in males.
Measured: Baseline and Day 28
Change in PROMIS Fatigue 10a Score
Between-group change in the PROMIS Fatigue 10a short form T-score from baseline to Day 28. The PROMIS Fatigue 10a is a validated 10-item self-reported questionnaire measuring fatigue severity and its impact on daily functioning over the past 7 days.
Measured: Baseline and Day 28
Safety and Tolerability
Within- and between-group changes from baseline to Days 14 and 28 in side effect profile using a custom Safety and Tolerability survey assessing symptoms including nausea, headache, mood changes, dizziness, bloating, itching, and sexual dysfunction.
Measured: Baseline through Day 14 and Day 28
Within group difference in total testosterone
To assess within-group differences from baseline to day 28 in Total Testosterone following Qualia Testosterone and Placebo supplementation.
Measured: Baseline to 28 days
Within-group differences in Free (Dialysis) Testosterone
To assess within-group differences from baseline to day 28 in Free (Dialysis) Testosterone following Qualia Testosterone and Placebo supplementation.
Measured: baseline to day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start19 May 2026
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Testosterone LevelsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qualia Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Colin Gardner, PhD, Principal investigator, Qualia Life Sciences, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07556458
- Sponsor's protocol ID
- QLS-022
- Status last verified
- Oct 2026
- First submitted
- 2 Apr 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Qualia Testosterone+ on Testosterone Levels: A Triple-Armed Placebo-Controlled Parallel Study
- ClinicalTrials.gov ID
- NCT07556458
- Acronym / sponsor ID
- QLS-022
- Conditions
- Low Testosterone Levels
- Keywords
- Testosterone, Dietary Supplement, Male Vitality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Qualia Life SciencesIndustry (pharma, biotech, devices)
- Study start
- 19 May 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 once daily in the morning for 28 consecutive days. The placebo consists of vegetable/cellulose capsules containing inert rice powder, matched to the active capsules in appearance.
Blood samples for total and free testosterone (equilibrium dialysis) will be collected at baseline and day 26-28 at Ulta-affiliated phlebotomy sites, with morning collection recommended. Symptom questionnaires (AMS Scale, PROMIS Fatigue 10a, Safety and Tolerability survey) will be completed electronically at baseline, day 14, and day 28. A follow-up questionnaire will be completed at day 32-34. Regular check-in surveys will assess adherence and safety on days 1, 3, 7, 14, 21, and 28.
Statistical analyses will include paired t-tests or linear mixed-effects models for within-group differences, and linear mixed-effects models with fixed effects for group, time, and their interaction for between-group comparisons. The sample size was estimated to yield 80% power to detect an effect size of Cohen's d = 0.80 with a two-tailed t-test at a 0.05 significance level.
Note on allocation (added September 2026): Participants were assigned to study arms by systematic allocation rather than by random allocation. Earlier versions of this record described the design as randomized. The Allocation field and the design descriptions were corrected to Non-Randomized to reflect the method actually used. No other aspect of the study design, conduct, or analysis changed.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Qualia Testosterone+ Formula 1 | Experimental | Dietary Supplement: Qualia Testosterone+Participants receive 3 capsules daily of Qualia Testosterone+ Formula 1 dietary supplement for 28 days. |
| Qualia Testosterone+ Formula 2 | Experimental | Dietary Supplement: Qualia Testosterone+Participants receive 3 capsules daily of Qualia Testosterone+ Formula 2 dietary supplement for 28 days. |
| Placebo | Placebo comparator | Other: PlaceboParticipants receive 3 capsules daily of matching placebo for 28 days. |
Who may qualify
- Ages
- 28 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | Qualia Testosterone+ Formula 1, Qualia Testosterone+ Formula 2 |
| PlaceboMatching placebo capsules. Participants take 3 capsules daily with breakfast for 28 days. | Other | Placebo |
Primary outcome
Change in Total Testosterone Levels
Time frame: Baseline and Day 28
Between-group change in serum total testosterone concentration from baseline to Day 28, measured via venous blood draw analyzed by a CLIA-certified laboratory. Comparison across Qualia Testosterone+ Formula 1, Formula 2, and Placebo groups using linear mixed-effects models.
6 secondary outcomes
Change in Free (Dialysis) Testosterone Levels
Time frame: Baseline and Day 28
Change in Aging Males' Symptoms (AMS) Scale Score
Time frame: Baseline and Day 28
Change in PROMIS Fatigue 10a Score
Time frame: Baseline and Day 28
Safety and Tolerability
Time frame: Baseline through Day 14 and Day 28
Within group difference in total testosterone
Time frame: Baseline to 28 days
Within-group differences in Free (Dialysis) Testosterone
Time frame: baseline to day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Colin Gardner, PhD principal investigator
Qualia Life Sciences, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Qualia Testosterone+ in people with Low Testosterone Levels, run by Qualia Life Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Colin Gardner, PhD (678-387-7924, colin@qualialife.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Total Testosterone Levels (time frame: Baseline and Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.