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OpenTrials
Completed

NCT Number: NCT06596928

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.

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Key information

Age range

30 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Citruslabs

Santa Monica, California, 90404, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Essential Elements T-Hero Platinum

Dietary Supplement

Participants will take two capsules daily for 90 days

Placebo

Dietary Supplement

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

Primary outcomes

  1. Change in Free and Total Testosterone Levels

    Time frame: 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 outcomes

  1. Change in Cognitive Function, Mood, Energy, and Sexual Function

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Scale Media Inc

Industry

Collaborators

  • Citruslabs

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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