30 Day
30-Day MoonBrew Sleep & Stress Study
| STUDY TITLE | 30-Day MoonBrew Sleep & Stress Study |
|---|---|
| Submitted under umbrella | |
| Date submitted |
Oct 8, 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 |
Andrew Case, andrew case, Matthew Amsden |
| Principal investigator |
Matthew Amsden |
| Sub-Investigator for Adverse Events |
Dr. Viral Patel |
| Description |
This study aims to assess how consuming MoonBrew each evening for 30 days impacts sleep quality and stress levels. Poor sleep and high stress often go hand-in-hand, worsening overall health. By using validated self-reported outcome measures, this study bridges the gap between anecdotal evidence and scientific proof (without requiring a connected health device), contributing valuable insights into natural solutions for better sleep. |
| 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
|
| 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” |
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 study:
Poor sleep and high stress levels are pervasive issues affecting millions globally, leading to significant health problems. Research has consistently shown that poor sleep quality can exacerbate stress, while high stress levels can further disrupt sleep patterns. We have some great anecdotal evidence that suggests Moonbrew really works. This study aims to bridge the gap between anecdotal evidence and scientific evidence.
My Objective for You:
My objective for you is to evaluate how consuming MoonBrew each evening for 30 days affects your sleep quality and stress levels. By participating, you will contribute valuable data that could help others seeking natural solutions for better sleep and stress relief.
Aims & Objectives:
The aim of this study is to scientifically assess the impact of MoonBrew on sleep quality and stress levels using the PROMIS Sleep Disturbance Scale and NIH Toolbox® Item Bank v3.0 – Perceived Stress survey. Our objective is to determine whether regular consumption of MoonBrew can significantly improve sleep patterns and reduce stress over a 30-day period.
Significance & Impact:
This study is significant as it seeks to provide scientific evidence on the efficacy of MoonBrew, a popular natural remedy, in enhancing sleep quality and reducing stress. Expected outcomes include improved sleep patterns and lower stress levels among participants. However, limitations include self-reported data and individual variations in response to MoonBrew. Nonetheless, the findings could pave the way for evidence-based recommendations and broader acceptance of natural sleep aids.
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.