The Efficacy of Qualia Testosterone+ on Testosterone Levels: A Randomized Triple-Armed Placebo-Controlled Parallel Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 75
- 主要终点
- Change in Total Testosterone Levels
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 28 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
- •Have Hypogonadism
- •On Testosterone Replacement Therapy
- •Taking Gonadotropin-releasing hormone (GnRH) injections or gonadotropins (hCG or FSH)
研究组 & 干预措施
Qualia Testosterone+ Formula 1
Participants receive 3 capsules daily of Qualia Testosterone+ Formula 1 dietary supplement for 28 days.
干预措施: Qualia Testosterone+ (Dietary Supplement)
Qualia Testosterone+ Formula 2
Participants receive 3 capsules daily of Qualia Testosterone+ Formula 2 dietary supplement for 28 days.
干预措施: Qualia Testosterone+ (Dietary Supplement)
Placebo
Participants receive 3 capsules daily of matching placebo for 28 days.
干预措施: Placebo (Other)
结局指标
主要结局
Change in Total Testosterone Levels
时间窗: 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.
次要结局
- Change in Free (Dialysis) Testosterone Levels(Baseline and Day 28)
- Change in Aging Males' Symptoms (AMS) Scale Score(Baseline and Day 28)
- Change in PROMIS Fatigue 10a Score(Baseline and Day 28)
- Safety and Tolerability(Baseline through Day 14 and Day 28)
- Within group difference in total testosterone(Baseline to 28 days)
- Within-group differences in Free (Dialysis) Testosterone(baseline to day 28)