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

NCT06596928 | Completed

• 1 other identifier: 20430
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Sexual Function; Cognitive Functions; Testosterone

Keywords

Mood

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Cognitive Function, Mood, Energy, and Sexual Function

  Baseline, Day 45, Day 90

Study Arms (2)

Test Supplement Group

EXPERIMENTAL

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

Placebo Group

PLACEBO COMPARATOR

Participants in this group will receive a placebo containing rice flour in a vegetable cellulose capsule.

Dietary Supplement: Placebo

Interventions

Essential Elements T-Hero Platinum DIETARY_SUPPLEMENT

Participants will take two capsules daily for 90 days

Test Supplement Group

Placebo DIETARY_SUPPLEMENT

Participants in the placebo group will take two placebo capsules daily for 90 days.

Placebo Group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Scale Media Inc: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: September 19, 2024
• Study Start: May 7, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)