30 Day
30-Day MoonBrew Sleep and Stress Study
STUDY TITLE | 30-Day MoonBrew Sleep and Stress Study |
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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 |
This study evaluates the effects of daily consumption of MoonBrew on participants’ sleep quality and stress levels over a 30-day period. Participants will consume MoonBrew each night before bedtime, aiming to assess changes in sleep patterns and perceived stress. |
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 |
$48 |
Included products & services |
MoonBrew – 30 Servings: $48
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Outcome measures |
PROMIS Sleep Disturbance Scale NIH Toolbox® Item Bank v3.0 – Perceived Stress (Ages 18+) – Fixed Form 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:
Sleep disturbances and stress are prevalent issues affecting adults in the United States, impacting overall well-being and productivity. Academic research has shown that natural supplements can positively influence sleep quality and stress reduction. Social media and popular press often tout the benefits of various herbal blends, creating a buzz around products like MoonBrew. This challenge combines credible scientific measures with the excitement of a social media challenge to evaluate the real-world impact of MoonBrew. It’s important to run this study to bridge the gap between anecdotal claims and scientific evidence.
My Objective for You:
My objective is for you to experience measurable improvements in your sleep quality and stress levels by participating in the 30-Day MoonBrew Sleep and Stress Study. Together, we aim to validate the benefits of MoonBrew through credible, standardized assessments.
Aims & Objectives:
The aim is to assess the impact of daily MoonBrew consumption on participants' sleep quality and stress levels over 30 days. Objectives include quantifying changes using the PROMIS Sleep Disturbance Scale and NIH Toolbox® Perceived Stress Survey.
Significance & Impact:
This challenge could significantly impact how we approach natural solutions for sleep and stress. Expected outcomes include improved sleep patterns and reduced stress levels, validated through reliable metrics. Limitations include participant adherence and individual variability in response to the supplement.
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.
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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