30 Day
MoonBrew Sleep Quality and Energy Level Assessment
STUDY TITLE | MoonBrew Sleep Quality and Energy Level Assessment |
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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 |
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Study author |
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Principal investigator |
Matthew Amsden |
Sub-Investigator for Adverse Events |
Dr. Viral Patel |
Description |
Participants will consume MoonBrew nightly for 30 days to assess its effects on sleep quality and energy levels. The intervention will focus on introducing MoonBrew as part of the nightly routine to promote better sleep. Participants will follow specific instructions for daily consumption and adherence to the protocol. |
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 |
$0 |
Included products & services |
MoonBrew – 30 Servings: $48
Apple Watch: $0
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Outcome measures |
PROMIS Item Bank v.1.0 – Sleep-Related Impairment 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” |
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:
With an increasing number of adults in the United States struggling with sleep quality and energy levels, it's essential to explore innovative solutions. Academic research has shown that consistent sleep patterns and certain natural supplements can significantly enhance sleep quality and daytime energy. On social media, numerous individuals have praised MoonBrew for its potential benefits. This challenge aims to merge scientific rigor with real-world application, making it crucial to assess MoonBrew's effectiveness through a structured study.
My Objective for You:
The goal is to help you improve your sleep quality and energy levels by incorporating MoonBrew into your nightly routine. By participating, you'll not only gain insights into your own health but also contribute to a broader understanding of sleep enhancement strategies.
Aims & Objectives:
This challenge aims to evaluate the impact of MoonBrew on sleep quality and energy levels over 30 days. Participants will follow a structured protocol to ensure accurate and reliable results.
Significance & Impact:
Improving sleep quality and energy levels can significantly enhance overall well-being and productivity. This challenge seeks to provide evidence-based insights while offering practical solutions for better sleep. While individual experiences may vary, the collective data will help identify effective strategies for sleep improvement.
The Intervention
Included Products & Services
Product Name: MoonBrew – 30 Servings
Quantity included: 1
Price: $48.00
Product Description: A calming and soothing blend of adaptogens with Chamomile, Rose, and Magnesium to help you catch the ZzZ's and stay asleep. Sleep tight and wake up refreshed. - 30 Servings of MoonBrew
Product Image:
Ingredients:
Bai Zi Ren extract
Juan Fu Ling extract
Yuan Zhi extract
Bai He extract
N/a spearmint
Lavender extract
L-Theanine
Lemon Balm extract
Chamomile extract
Jujube seed extract
Turkey Tail extract
Reishi Extract
Valerian Root
Magnesium glycinate
Product Safety:
MoonBrew is designed to support sleep quality and stress reduction. It incorporates a variety of herbal extracts and compounds known for their potential benefits in these areas. However, as with any treatment, there are risks associated with its use. This document outlines these risks, based on available data from academic research, anecdotal evidence, and theoretical concerns.
Possible adverse events associated with MoonBrew include a range of theoretical side effects. These may encompass allergic reactions (such as rash, itching, swelling, dizziness, or difficulty breathing), which can vary in incidence and typically resolve after discontinuation. Gastrointestinal discomfort, including diarrhea, nausea, and stomach cramps, is considered to have a moderate incidence and usually subsides upon stopping use. Sedation and drowsiness are also moderately common. Interactions with medications, while less frequent, can occur and their resolution depends on the specific medication involved. Other potential effects include hormonal changes, sleep disturbances (like changes in sleep patterns, insomnia, or vivid dreams), blood pressure alterations, and impacts on the immune system. These effects generally have a low to moderate incidence and often resolve after discontinuing MoonBrew. Some users might experience frustration or irritation with the study experience, though this is relatively uncommon. It's important to note that the recovery from these side effects can vary, with most resolving after discontinuation of the product, while others may require monitoring or management as per medical advice.
Long-term Dependence
Long-term dependence on MoonBrew is unlikely due to its composition of vitamins and herbs and short treatment duration. However, psychological dependence on its effects cannot be entirely ruled out.
Legality and Compliance
MoonBrew’s ingredients are generally recognized as safe and legal. Its use should comply with regulations of relevant governing bodies such as the World Anti-Doping Association, National Collegiate Athletic Association, and general Corporate Workplace standards. Consult these entities if your participation in sports or employment is subject to specific substance use policies.
This assessment aims to provide thorough information on the risks associated with MoonBrew, but may not be complete. There may be unknown risks at this time. All participants are encouraged to monitor their health closely and report any concerns to their healthcare provider and Efforia.
Product Name: Apple Watch
Quantity included: 0
Price: $0.00
Product Description: Efforia can pull in data from your existing Apple Watch such as sleep and activity data. Please see other retailers to purchase a device if you do not have one.
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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