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

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.

Study Overview

• Status: Completed
• Conditions: Sexual Function; Testosterone; Cognitive Functions
• Intervention / Treatment: Dietary supplement: Essential Elements T-Hero Platinum; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 90404
      • Citruslabs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Supplement Group; 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.	Dietary supplement: Essential Elements T-Hero Platinum; Participants will take two capsules daily for 90 days
Placebo Comparator: Placebo Group; Participants in this group will receive a placebo containing rice flour in a vegetable cellulose capsule.	Dietary supplement: Placebo; Participants in the placebo group will take two placebo capsules daily for 90 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Free and Total Testosterone Levels	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.	Baseline, Day 45, Day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Cognitive Function, Mood, Energy, and Sexual Function	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.	Baseline, Day 45, Day 90

Collaborators and Investigators

• Sponsor: Scale Media Inc
• Collaborators: Citruslabs

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2024
• Primary Completion (Actual): September 1, 2024
• Study Completion (Actual): September 1, 2024

Study Registration Dates

• First Submitted: September 11, 2024
• First Submitted That Met QC Criteria: September 11, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 11, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Mood
• Other Study ID Numbers: 20430 (Other Identifier: City of Hope Medical Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No