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

Scale Media Inc

Status: Completed

Conditions: Cognitive Functions; Sexual Function; Testosterone

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Essential Elements T-Hero Platinum

Study type: Interventional

Funder types: Industry

Identifiers

NCT06596928

20430

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: Male

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups, including a placebo group

Test Supplement Group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Essential Elements T-Hero Platinum

Placebo Group

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo