90 Day
Impact of Testosterone Therapy on Levels
STUDY TITLE | Impact of Testosterone Therapy on Levels |
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Submitted under umbrella | |
Date submitted |
- |
End date |
There is no pre-specified end date and sub-studies remain open long-term. |
Language |
English |
Efforia AI IRB approval recommendation | |
Recruitment page preview | |
Author edit | |
Informed consent |
|
Study author |
|
Principal investigator |
Matthew Amsden |
Sub-Investigator for Adverse Events |
Dr. Viral Patel |
Description |
This protocol investigates the effects of testosterone replacement therapy on testosterone levels in adult males. Participants will receive prescribed testosterone doses under medical supervision, aiming to assess changes in hormonal levels and overall well-being. |
Participant engagement length |
90 Days |
Sponsor |
This study is made possible by your payment to cover all supplies and expenses required to participate. |
Cost to participant |
$79 |
Included products & services |
MarsMen Natural Testosterone Support: $79
Men’s Health Blood Test: $159
|
Outcome measures |
Men’s Health Blood Test PROMIS Short Form v1.0 – Fatigue 8a |
Methodology |
Single Arm longitudinal where participants act as their own control |
Basic or advanced dissemination plan |
Basic |
Deviation from recruitment approach |
No |
Deviation from statistical approach |
No |
Will study include “more about you questions” |
Yes |
Recruitment jurisdictions |
United States, United Kingdom |
Clinicaltrials.Gov |
Yes |
Committment to list findings on clinicaltrials.Gov |
Yes |
This document is prepared with the assistance of AI, but is reviewed by a human.
Rational & Study Design
Why I created this challenge:
The discourse around testosterone therapy in men has been polarized between groundbreaking academic findings and vibrant social media debates. Research indicates potential benefits in energy, mood, and physical health, while folklore often exaggerates outcomes. This challenge aims to bring scientific rigor to these conversations, providing robust data on testosterone levels, fatigue, and well-being changes over 90 days. It’s essential to clear the myths and highlight the true impact of testosterone therapy.
My Objective for You:
This challenge is designed to rigorously measure the impact of testosterone therapy on your hormonal health and overall well-being, using scientifically validated tools and under professional supervision, over a 90-day period.
Aims & Objectives:
The primary aim is to evaluate the effect of testosterone replacement therapy on serum testosterone levels in adult males. Secondly, we aim to assess the associated changes in fatigue and overall well-being, providing a comprehensive overview of the therapy’s efficacy.
Significance & Impact:
This challenge stands to significantly enhance our understanding of testosterone therapy’s impact on men’s health. Expected outcomes include validated insights into hormonal regulation and subjective well-being improvements. Recognizing the limitations, this study will also identify areas needing further research, contributing valuable data to both scientific and public domains.
The Intervention
Included Products & Services
Product Name: MarsMen Natural Testosterone Support
Quantity included: 3
Price: $79.00
Product Description: This testosterone supplement is formulated with a blend of herbal ingredients and vitamins. The ingredients include Tongkat Ali, Vitamin K1 & K2, Shilajit, Fenugreek Seeds, Vitamin D, Boron, Zinc, and Taurine. It is designed to support natural testosterone leverls and men's overall health and wellness.
Product Image:
Ingredients:
K1 & K2: 100 MG
Shilajit: 400 MG
Tongkat Ali: 1,000 MG
Fenugreek Seeds: 675 MG
Vitamin D: 4,000 IU
Boron: 4 MG
Zinc: 30 MG
Taurine: 675 MG
Product Safety:
1. K1 & K2 (100 mg)
Function: Supports bone health, density, and mood, promotes testosterone production.
Safety Profile: Generally regarded as safe (GRAS) when used within recommended dosages. High doses of Vitamin K may interfere with blood-thinning medications like warfarin.
Adverse Effects: Rare at typical doses; possible gastrointestinal discomfort or allergic reactions in sensitive individuals.
Contraindications: Caution in individuals taking anticoagulants.
2. Shilajit (400 mg)
Function: Improves fertility, boosts testosterone levels.
Safety Profile: Considered safe at recommended doses. Long history of use in Ayurvedic medicine.
Adverse Effects: Rare cases of allergic reactions or mild gastrointestinal disturbances.
Contraindications: Avoid in individuals with hemochromatosis (high iron levels), as it may increase iron absorption.
3. Tongkat Ali (1,000 mg)
Function: Boosts testosterone, enhances libido, improves fertility, and supports muscle growth.
Safety Profile: Safe for short-term use at recommended doses. Clinical studies show no significant toxicity.
Adverse Effects: Insomnia, irritability, and restlessness reported in some users, particularly at higher doses.
Contraindications: Individuals with hormone-sensitive conditions (e.g., prostate cancer) should avoid use due to its testosterone-boosting effects.
4. Fenugreek Seeds (675 mg)
Function: Supports testosterone, aids male vitality, reduces DHT levels.
Safety Profile: Generally safe when used in appropriate dosages. Used in traditional medicine for centuries.
Adverse Effects: Mild gastrointestinal upset, diarrhea, or bloating in sensitive individuals. May lower blood sugar levels.
Contraindications: Avoid in individuals with allergies to legumes. Caution in individuals on antidiabetic medications due to potential hypoglycemic effects.
5. Vitamin D (4,000 IU)
Function: Essential for cellular health, regulates testosterone production.
Safety Profile: Safe within the tolerable upper intake level (4,000 IU/day). Toxicity is rare but can occur with excessive long-term use.
Adverse Effects: Hypercalcemia at excessive doses (nausea, vomiting, weakness).
Contraindications: Caution in individuals with hypercalcemia or sarcoidosis.
6. Boron (4 mg)
Function: Supports testosterone regulation, helps manage estrogen levels.
Safety Profile: Generally considered safe in doses up to 20 mg/day. Boron supplementation is well-tolerated in clinical trials.
Adverse Effects: High doses (above 20 mg/day) may cause nausea, vomiting, or diarrhea.
Contraindications: Pregnant or breastfeeding women should avoid high doses due to insufficient data on long-term safety.
7. Zinc (30 mg)
Function: Essential for testosterone metabolism and immune function.
Safety Profile: Safe at recommended doses. Long-term high doses (>40 mg/day) can lead to copper deficiency and weakened immune function.
Adverse Effects: Nausea, vomiting, or diarrhea at high doses.
Contraindications: Avoid prolonged high doses to prevent copper depletion.
8. Taurine (675 mg)
Function: Reduces oxidative stress, improves blood flow, and supports testosterone levels.
Safety Profile: Considered safe with no significant adverse effects reported at typical supplemental doses.
Adverse Effects: Rare and mild, including headache or gastrointestinal upset.
Contraindications: Caution in individuals with bipolar disorder due to potential mood-stabilizing effects that may interfere with medications.
General Notes:
Overall Safety: The ingredients are considered safe when used within the recommended dosages for adults. Most ingredients have a well-documented history of use in both traditional and modern settings.
Monitoring: Special attention should be given to individuals with pre-existing health conditions, especially hormone-sensitive cancers, anticoagulant use, and individuals on antidiabetic or hypertensive medications.
Long-Term Use: While short-term use appears safe for all ingredients listed, further long-term studies are recommended for high-dosage and combined use of these supplements.
Product Name: Men’s Health Blood Test
Quantity included: 2
Price: $159.00
Product Description: Efforia, in collaboration with Tasso, introduces the "Comprehensive Men's Health Test," covering Total and Free Testosterone, Albumin, SHBG, PSA, DHEA-S, and Estradiol. Our advanced, shoulder-worn device collects a small blood sample easily and without needles. A bit pricier, yet much less daunting than standard methods, it's perfect for the needle-shy. Simply return it in the included pre-paid envelope for detailed lab analysis. Convenient, eff
Product Image:
Ingredients:
Product Safety:
Study Design & Methodology
Inappropriate Participants & Inclusion/Exclusion
Study Design & Experience
Statistical Analysis Plan
Limitations & Justification
Human Subjects Ethics
Suitability Under Minimal Risk Umbrella Protocol
Suitability for Pay to Participate Model
Human Subjects Protection Questionnaire
Logging
Logging
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