A Clinical Trial to Evaluate the Efficacy of a Men's Supplement in Supporting Testosterone, Improving Cognitive Function, Mood, and Sexual Function

Not Applicable

Completed

• Conditions: Sexual Function; Cognitive Functions; Testosterone
• Interventions: Dietary Supplement: Essential Elements T-Hero Platinum; Dietary Supplement: Placebo

• Registration Number: NCT06596928
• Lead Sponsor: Scale Media Inc

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-07
• Status Verified: 2024-09
• Primary Completion: 2024-09-01
• Study Completion: 2024-09-01
• Study First Submitted: 2024-09-11
• Study First Submitted QC: 2024-09-11
• Last Update Submitted: 2024-09-11
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test Supplement Group	Essential Elements T-Hero Platinum	Participants in this group will receive the test supplement (Essential Elements T-Hero Platinum). The supplement contains ingredients aimed at supporting testosterone levels, including Shoden® Ashwagandha Root and Leaf Extract.
Placebo Group	Placebo	Participants in this group will receive a placebo containing rice flour in a vegetable cellulose capsule.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Citruslabs; 🇺🇸 Santa Monica, California, United States