30 Day
Mars Men’s Impact on Energy Levels, Sleep and Fatigue
| STUDY TITLE | Mars Men’s Impact on Energy Levels, Sleep and Fatigue |
|---|---|
| Submitted under umbrella | |
| Date submitted |
Sep 24, 2024 |
| 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 |
Benjamin Smith, Patrick Killen |
| Principal investigator |
Matthew Amsden |
| Sub-Investigator for Adverse Events |
Dr. Viral Patel |
| Description |
Balancing testosterone is key to well-being and vitality. Join our 30-day Mars Men Testosterone Support study. As part of this trial, for measuring your energy, resilience and fatigue at baseline, you'll receive a 30 day supply of our supplements. Each morning you'll take a dose. And every two weeks answer a series of questions. in doing so, you'll measure how this natural dietary supplement blend improves your life. |
| Participant engagement length |
30 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
|
| Outcome measures |
Rating of Perceived Exertion (RPE) Survey Fatigue Perception and Impact Survey PROMIS Item Bank v.1.0 – Sleep-Related Impairment Survey Brief Resilience Scale (BRS) Survey |
| 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” |
No |
| Clinicaltrials.Gov |
Yes |
| Committment to list findings on clinicaltrials.Gov |
Yes |
Preview This document is prepared with the assistance of AI, but is reviewed by a human.
Rational & Study Design
Why I created this protocol:
In light of emerging research linking testosterone levels to energy and vitality and the pervasive social media narratives about testosterone boosters enhancing life quality, this protocol was born. Studies suggest that optimal testosterone levels may correlate with improved energy, yet much of our understanding is based on trials using Testosterone Replacement Therapies (TRT) that have significant side effects. This study seeks to provide a structured, evidence-based assessment of the impact Mars Men's natural supplement's effect on energy, bridging scientific inquiry with personal health empowerment.
Safety and Potential Adverse Reactions:
While the ingredients in this supplement are generally considered safe, anecdotal reports suggest that use may affect sleep quality, so we are including a measure of sleep in these studies. In addition, some report minor headaches, gastro intestinal distress. Anecdotally some on social media report potential hair loss.
My Objective for You:
This challenge aims to empower you with firsthand experience and scientific data. By participating, you’ll contribute to a better understanding of how an herbal testosterone support formula affects your energy levels.
Aims & Objectives:
Our primary aim is to evaluate changes in fatigue and energy as measured by a series of validated patient reported outcome measures over 30 days.
Significance & Impact:
This protoco. stands to significantly impact personal and wider public health narratives by scientifically validating or challenging the claims surrounding testosterone supplements overall energy and vitality. Participants will gain insights into their own health while contributing to broader knowledge. The findings could potentially guide future recommendations and personal health decisions, though limitations in generalizability and individual variability in response to supplements will be considered.
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.