Cognitive Functions, Sexual Function, Testosterone
Conditions
Keywords
Mood
Brief summary
This randomized, triple-blind, placebo-controlled, hybrid trial aims to evaluate the efficacy of a men's supplement designed to increase testosterone levels and improve energy, cognition, and sexual function. The study will involve 50 male participants, with assessments carried out at Baseline, Day 45, and Day 90 through questionnaires and blood tests.
Interventions
DIETARY_SUPPLEMENTEssential Elements T-Hero Platinum
Participants will take two capsules daily for 90 days
DIETARY_SUPPLEMENTPlacebo
Participants in the placebo group will take two placebo capsules daily for 90 days.
Sponsors
Citruslabs
Scale Media Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
30 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male (biological at birth). * Aged between 30-65. * Generally healthy - do not live with any uncontrolled chronic disease such as diabetes or hypertension. * Willing to provide blood draws during the study duration. * Fitness/wellness enthusiast who has the same weekly exercise routine i.e. HIIT, strength training, or running >3 times per week. * Self-reported concerns with energy levels, mood, and libido and sexual performance/adequacy. * Willing to avoid medications, supplements, or vitamins aimed at increasing testosterone levels for the duration of the study.
Exclusion criteria
* Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders. * Anyone with known severe allergic reactions requiring the use of an Epi-Pen. * Unwilling to follow the study protocol. * Currently experiencing significant symptoms of a mental disorder that might interfere with study participation (e.g., eating disorder, obsessive-compulsive disorder, posttraumatic stress syndrome, bipolar disorder). * Current substance abuse disorder. * Any medical condition that is unstable or uncontrolled. * Has introduced any new prescription medication or supplements within the past 12 weeks that influence testosterone production. * History of testicular or prostate cancer. * Previously has undergone a vasectomy. * Currently undergoing hormone replacement therapy (HRT) * Currently taking performance-enhancing drugs. * Anyone taking prescription blood pressure, immunosuppressants, sleeping aids, anti-seizure, and/or thyroid medications. * Living in New York, Rhode Island, Hawaii, or Alaska.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Free and Total Testosterone Levels | Baseline, Day 45, Day 90 | This study will measure the changes in free and total testosterone levels in male participants. Blood samples will be collected at Baseline, Day 45, and Day 90. The primary goal is to assess the effectiveness of the test supplement in increasing testosterone levels compared to the placebo group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cognitive Function, Mood, Energy, and Sexual Function | Baseline, Day 45, Day 90 | This study will assess self-reported changes in cognitive function, mood, energy levels, and sexual function. Participants will complete validated questionnaires, including the Profile of Mood States (POMS) questionnaire, at Baseline, Day 45, and Day 90. The goal is to evaluate improvements in these parameters and their correlation with increased testosterone levels. |
Countries
United States
Outcome results
None listed