60 Day

Alejandro’s Moonbrew Evening and Morning Routine

STUDY TITLE Alejandro’s Moonbrew Evening and Morning Routine
Submitted under umbrella

Minimal Risk Citizen Science Umbrella Protocol

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

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Study author

Alejandro Facundo, andrew case

Principal investigator

Matthew Amsden

Sub-Investigator for Adverse Events

Dr. Viral Patel

Description

You already know how great MoonBrew is. Let's level up. Follow Noonbrew's own Alejandro Facundo's routine in this simple morning and evening routine. Mix MoonBrew with your favorite vanilla protein powder and drink it within 90 minutes of bedtime. In the morning, expose your face to 5 minutes of daylight right after waking up. And, let's see if it improves your life: track your sleep with your Apple Watch and an NIH validated sleep assessment.

Participant engagement length

60 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
Apple Watch: $0
Outcome measures

PROMIS Sleep Disturbance Scale

Apple Watch Sleep Tracking

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:

I've been following this morning and night routine for almost a year. I love it. You already know how great MoonBrew is for a restful night of sleep. Beyond that, scholarly research supports the benefits of protein before bed and natural light to regulate circadian rhythms, impacting sleep quality. Social media and popular press often tout sleep routines with a bunch of anecdotal. This study aims to scientifically validate my routine through a structured protocol, providing concrete evidence of its effectiveness.

My Objective for You:

I'd like you to adjust your current MooonBrew routine to include mixing with your choice of vanilla protein powder and waking up to a quick 5 minutes of daylight on your face. This associated study is designed to rigorously assess how the combination of a nightly protein-enriched MoonBrew and morning sunlight exposure can systematically improve your sleep quality using validated tools.

Aims & Objectives:

The primary aim is to evaluate changes in sleep quality from baseline to day 60 using the PROMIS Sleep Disturbance Scale and Apple Watch Sleep Tracking. Secondly, we aim to establish a correlation between the routine and changes in these validated sleep measures.

Significance & Impact:

This routine and associated study could significantly impact our understanding of simple, non-pharmacological methods to enhance sleep quality. Expected outcomes include improved sleep scores and insights into daily routines’ effectiveness on sleep health. The findings could potentially shift everyday health practices and influence future sleep-related recommendations, bearing in mind the limitations of individual variability in response to interventions.

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

Date Event Message Name
Oct 08, 2024 12:55:19 modified Modified the value of the entry Shipping
MoonBrew – 30 Servings.
12650
associate_product
published
Previous entry value: 0
New entry value: 1
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alejandro
Oct 08, 2024 12:55:19 modified Modified the value of the entry Shipping
MoonBrew – 30 Servings.
12650
associate_product
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alejandro
Oct 08, 2024 12:55:19 modified Added tag(s) to the post MoonBrew – 30 Servings.
12650
associate_product
published
Added tag(s): deep sleep, nighttime ritual, REM Sleep, sleep, sleep quality
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alejandro
Oct 08, 2024 12:55:10 modified Modified the value of the entry Safety Side Effects
MoonBrew – 30 Servings.
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New entry value: MoonBrew is designed to support sleep quality and …
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Oct 08, 2024 12:55:10 modified Modified the value of the entry Description And Ingredients
MoonBrew – 30 Servings.
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New entry value: Bai Zi Ren extract<br /> Juan Fu Ling extract<br /…
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alejandro
Oct 08, 2024 12:55:10 modified Modified the value of the entry Shipping
MoonBrew – 30 Servings.
12650
associate_product
published
Previous entry value: 0
New entry value: 1
View the post in editor
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alejandro
Oct 08, 2024 12:55:10 modified Modified the value of the entry Shipping
MoonBrew – 30 Servings.
12650
associate_product
published
Previous entry value: 1
New entry value: 0
View the post in editor
Exclude entry from the monitoring
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alejandro
Oct 08, 2024 12:55:10 modified Added tag(s) to the post MoonBrew – 30 Servings.
12650
associate_product
published
Added tag(s): deep sleep, nighttime ritual, REM Sleep, sleep, sleep quality
View the post in editor
alejandro
Oct 08, 2024 12:52:13 modified Modified the value of the entry Shipping
MoonBrew – 30 Servings.
12650
associate_product
published
Previous entry value: 0
New entry value: 1
View the post in editor
Exclude entry from the monitoring
URL
alejandro
Oct 08, 2024 12:52:13 modified Modified the value of the entry Shipping
MoonBrew – 30 Servings.
12650
associate_product
published
Previous entry value: 1
New entry value: 0
View the post in editor
Exclude entry from the monitoring
URL
alejandro
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