Clinical trial NCT06596928: A Clinical Trial to Evaluate the Efficacy of a Men's Supplement in Supporting Testosterone, Improving Cognitive Function, Mood, and Sexual Function
Official title: A Clinical Trial to Evaluate the Efficacy of a Men's Supplement in Supporting Testosterone, Improving Cognitive Function, Mood, and Sexual Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Function
Cognitive Functions
Testosterone
Keywords: Mood
Lead sponsor: Scale Media Inc
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2024-09-19
Enrollment: 50
Sex: MALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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 \&amp;gt;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.

Primary outcomes:
measure: Change in Free and Total Testosterone Levels
timeFrame: Baseline, Day 45, Day 90
Secondary outcomes:
measure: Change in Cognitive Function, Mood, Energy, and Sexual Function
timeFrame: Baseline, Day 45, Day 90
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References: