Low Testosterone Levels
Conditions
Keywords
Testosterone, Dietary Supplement, Male Vitality
Brief summary
This is a randomized, 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 randomized 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 randomly assigned 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.
Interventions
DIETARY_SUPPLEMENTQualia 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.
OTHERPlacebo
Matching placebo capsules. Participants take 3 capsules daily with breakfast for 28 days.
Sponsors
Qualia Life Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
28 Years to 65 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Testosterone Levels | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Free (Dialysis) Testosterone Levels | Baseline and Day 28 | 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. |
| Change in Aging Males' Symptoms (AMS) Scale Score | Baseline and Day 28 | 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. |
| Change in PROMIS Fatigue 10a Score | Baseline and Day 28 | 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. |
| Safety and Tolerability | Baseline through Day 14 and Day 28 | 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. |
| Within group difference in total testosterone | Baseline to 28 days | To assess within-group differences from baseline to day 28 in Total Testosterone following Qualia Testosterone and Placebo supplementation. |
| Within-group differences in Free (Dialysis) Testosterone | baseline to day 28 | To assess within-group differences from baseline to day 28 in Free (Dialysis) Testosterone following Qualia Testosterone and Placebo supplementation. |
Contacts
CONTACTColin Gardner, PhD
PRINCIPAL_INVESTIGATORColin Gardner, PhD
Qualia Life Sciences, LLC
Outcome results
None listed