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

NCT ID: NCT06596928

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-07
• Study Completion Date: 2024-09-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Essential Elements T-Hero Platinum

Intervention Type: DIETARY_SUPPLEMENT

Participants will take two capsules daily for 90 days

Placebo Group

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Essential Elements T-Hero Platinum

Participants will take two capsules daily for 90 days

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Citruslabs

INDUSTRY

Sponsor Role: collaborator

Scale Media Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Citruslabs

Santa Monica, California, United States

Countries

United States

Other Identifiers

20430

Identifier Type: -

Identifier Source: org_study_id