30 Day
30-Day MoonBrew Sleep & Stress Study (13210-MR)
| STUDY TITLE | 30-Day MoonBrew Sleep & Stress Study |
|---|---|
| Submitted under umbrella |
Minimal Risk Citizen Science Umbrella Protocol |
| Date submitted |
Date is important |
| Efforia ai irb approval recommendation |
Approve |
| Recruitment page preview | |
| Line for Something else |
|
| Line for Something else |
|
| Author edit | |
| Informed consent | |
| Study author |
Alejandro Facundo, VP of Customer Experience, Moonbrew, Andrew Case, CEO Moonbrew |
| Principal investigator |
Matthew Amsden |
| Description |
The study involves participants consuming MoonBrew every evening to enhance sleep quality and reduce stress. Participants will drink MoonBrew 1-2 hours before their planned bedtime to assess its effects on self-reported sleep patterns and stress levels over a 30-day period. |
| Participant engagement length |
30 Days |
| Deviation from dissemination plan |
No |
| Deviation from recruitment approach |
No |
| Will study include “more about you questions” |
Yes |
| Recruitment geographies |
United States |
| Line for something else |
|
It is expected that reviewers will familiarize themselves with the umbrella protocol that governs the details of this sub-study. The umbrella provides all the details that are common across studies.
A Note from Study Authors
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:
his 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
Product / Service
Adam Health
The Adam Sensor is a penis ring made by Adam Health that can track nighttime erections. It's attached to the base of the penis with a band and worn overnight. The Adam Sensor can help specialists diagnose biological erectile dysfunction. It can also track fitness, daily steps, calories, and credit./
- FDA ID: FDA ID:
- Measurement: placebo, treatment, etc.
- Shipping: Yes
- Price: $13,99
- Whether a user can bring their own: No
Active ingredients in the supplement such as Magnesium, Valerian root, chamomile flower, L-Theanine and other components of the Adaptogen & Calming blend all have some (often limited) clinical evidence of impact on sleep. Additionally these items have long standing in folk, natural and eastern medicinal communities.
Safety & Inappropriate Participants
All ingredients in Moonbrew are classified as GRAS under US law. Still, there are some low level risks and known side effects and risks associated with these ingredients include allergic reactions, gastrointestinal issues, sedation, medication interactions, hormonal effects, liver effects, sleep disturbances, blood pressure changes, and immune system effects. Most side effects observed in studies or reported anecdotally are mild and transient. This product has slightly elevated levels of lead based on third-party lab tests, and requires a
| THEORETICAL SIDE EFFECTS | RELATIVE INCIDENCE | RECOVERY |
|---|---|---|
| Allergic Reactions (rash, itching, swelling, dizziness, difficulty breathing) | Low | Typically resolves after discontinuation |
| Gastrointestinal Discomfort (diarrhea, nausea, stomach cramps) | Moderate | Typically resolves after discontinuation |
| Sedation and Drowsiness | Moderate | Typically resolves after discontinuation |
| Interactions with Medications | Low to Moderate | Dependent on medication involved |
| Hormonal Effects | Low | Dependent on individual hormonal sensitivity |
| Gastrointestinal and Liver Effects | Low | Typically resolves after discontinuation |
| Sleep Disturbances (changes in sleep patterns, insomnia, vivid dreams) | Moderate | Typically resolves after discontinuation |
| Blood Pressure Changes | Low | Monitor and manage as per medical advice |
| Immune System Effects | Low | Depends on individual immune condition |
| Frustration and irritation | Low | Typically resolves after discontinuation |
Long-term Dependence
No long-term dependence has been reported with the use of MoonBrew. However, continuous monitoring and research are advised to better understand the potential for dependence.
Individuals Who Should Not Join this Study
Individuals Who Should Not Join this Study
| Type of Person | Why |
|---|---|
| Pregnant or breastfeeding women | Some herbs may affect pregnancy or lactation. |
| Individuals on blood thinners | Some ingredients may interact with blood thinning medications. |
| Some ingredients may interact with blood thinning medications. | Some individuals may have allergic reactions to ingredients. |
| Individuals with autoimmune diseases | Certain adaptogens may stimulate the immune system. |
| Individuals with allergies to mushrooms | Contains Reishi and Turkey Tail mushrooms. |
| Individuals with allergies to tree nuts | Contains coconut, which is a tree nut. |
| Individuals with anxiety disorders | L-Theanine may interact with anxiety medications. |
| Individuals with high blood pressure | Certain ingredients may affect blood pressure levels. |
| Individuals on antidepressants or anti-anxiety medications | Potential interaction with medications. |
Study Design & Experience
The study spans 30 days. During this period, you will engage in specific activities designed to assess and improve your sleep quality and stress levels.
Target Population
Healthy individuals in the United States who are interested in improving their sleep quality and associated daytime stress levels.
Treatment Activities
Daily Activity: Consume MoonBrew nightly as part of your routine before bed.
Assessments and Frequency
- Day 1: Complete the Baseline Sleep Quality Assessment and Baseline Perceived Stress Assessment.
- Weekly (Days 7, 14, 21, 28): Complete the Weekly Sleep Quality Assessment and Weekly Perceived Stress Assessment.
Methodology
The study spans 30 days. During this period, you will engage in specific activities designed to assess and improve your sleep quality and stress levels.
Expected Sample Size
600-1000
We expect a relatively modest drop out rate in this study given the low effort required. Therefore sample sizes are significantly smaller than the worst case scenario as defined in the umbrella protocol. Sample size may be adjusted if drop out rates are higher than expected.
Limitations & Justification
The 30-Day MoonBrew Sleep & Stress Study, while robust in its aims and methodology, has several limitations. Firstly, the reliance on self-reported data for assessing sleep quality and stress levels introduces potential biases and inaccuracies due to subjective interpretation by participants. The study’s single-arm design, where participants act as their own control, lacks a comparative group, which may affect the strength of causal inferences drawn from the results. Additionally, the absence of objective sleep measurements, such as polysomnography or actigraphy, limits the ability to validate self-reported outcomes with precise sleep data. The study also excludes vulnerable populations and those with certain health conditions, which may limit the generalizability of the findings to a broader population. Lastly, the potential for selection bias exists, as participants may be more health-conscious and motivated, which could influence their response to the intervention and the overall study outcomes. These limitations should be considered when interpreting the results and drawing conclusions about the efficacy of MoonBrew in improving sleep quality and reducing stress.
The study authors chose to use this approach, and participant self reported outcomes to reduce the requirement for expensive connected health devices and therefore increase access. This is the first study on Moonbrew, and the first study by the study authors, and they would like to progress incrementally.
A positive signal within this initial study will progress Moonbrew to an on/off study, and then potentially a placebo controlled RCT.
Suitability Under Minimal Risk Umbrella Protocol
| Consideration | Protocol Adherence | Qualification |
|---|---|---|
| Minimal risk studies: those presenting no more harm or discomfort than daily life | The study involves consuming MoonBrew, which contains ingredients classified as GRAS under US law. Side effects are mild and transient, and the study involves minimal risk. | Suitable |
| Studies examining legal, easily accessible interventions without a prescription | MoonBrew is a legal dietary supplement available without a prescription. | Suitable |
| Studies focused on enhancing general health, productivity, and wellness within normal ranges | The study aims to enhance sleep quality and reduce stress, which are within the normal range of general health and wellness. | Suitable |
| Studies analyzing "Generally Recognized as Safe" (GRAS) interventions | MoonBrew's ingredients are classified as GRAS. | Suitable |
| Studies within the broad “health and wellness” domain | The study falls within the health and wellness domain, focusing on sleep quality and stress reduction through a natural dietary supplement. | Suitable |
| Longitudinal studies lasting at least several days | The study duration is 30 days. | Suitable |
| Studies that have two or less blood draws or other bodily fluid specimen collection | The study does not involve any blood draws or bodily fluid specimen collection. | Suitable |
| Studies involving more than minimal risk | The study involves minimal risk, adhering to the guidelines of minimal risk studies. | Suitable |
| Studies that include vulnerable populations | The study excludes vulnerable populations such as children, pregnant women, and incarcerated individuals. | Suitable |
| Studies requiring a physician's diagnosis or prescription | The study does not require a physician's diagnosis or prescription. | Suitable |
| Studies designed to test impacts of interventions on individuals with a diagnosed disease | The study targets healthy individuals interested in improving sleep quality and stress, not individuals with diagnosed diseases. | Suitable |
| Studies examining interventions classified as medical devices or regulated pharmaceuticals | MoonBrew is a dietary supplement, not classified as a medical device or regulated pharmaceutical. | Suitable |
| Studies that include vulnerable populations | The study excludes vulnerable populations such as children, pregnant women, and incarcerated individuals. | Suitable |
| Studies examining interventions banned by sports regulatory bodies | MoonBrew does not contain ingredients banned by sports regulatory bodies. | Suitable |
| Studies involving interventions subject to regulatory approval | MoonBrew is a dietary supplement not subject to regulatory approval as a pharmaceutical or medical device. | Suitable |
| Studies incorporating any form of blinding or deception | The study is a single arm observational study with no blinding or deception involved. | Suitable |
| Studies require more than two blood draws per week | The study does not involve any blood draws. | Suitable |
| Studies involving elements illegal in the defined jurisdiction | All elements of the study, including MoonBrew, are legal in the United States. | Suitable |
| Comparative study designs | The study is a single arm longitudinal study, not a comparative study. | Suitable |
| Studies requiring specific eligibility criteria beyond legal availability | The eligibility criteria are based on general health and legal availability of the intervention. | Suitable |
| Intentionally biased studies | The study aims to scientifically assess the effects of MoonBrew without intentional bias. | Suitable |
| Single point in time studies or surveys | Single point in time studies or surveys | Suitable |
| Political polls, Opinion surveys, focus groups | The study focuses on health outcomes and does not involve political polls, opinion surveys, or focus groups. | Suitable |
| Studies including individuals under the age of consent | The study targets adults only, excluding individuals under the age of consent. | Suitable |
| Studies that contain sexual content primarily designed for titillation | The study does not contain sexual content. | Suitable |
| Studies requiring more protocol design flexibility than the base Efforia functionality | The study follows the base Efforia functionality and does not require additional protocol design flexibility. | Suitable |
| Studies without a defined intervention | Studies without a defined intervention | Suitable |
| Studies purposefully biased, unnecessarily sexualized, or depicting violence | The study is scientifically structured, without bias, sexualization, or depiction of violence. | Suitable |
| Studies defining changes in brand opinion | The study measures health outcomes, not changes in brand opinion. | Suitable |
Suitability for Pay to Participate Model
The product is available on the open market at this price point. No additional products or services have been added. Participants gain additional benefit by tracking their own results. Broader community gets additional benefits with more robust safety measures. A positive signal will progress this study to more robust study designs, providing more scientifically robust evidence about this product.
University of Portsmouth Questions
Beneficence
- Is there a description, unambiguous research question, and purpose?
- Yes. The study’s purpose is clearly stated: to explore the effects of MoonBrew on sleep quality and stress levels over a 30-day period using validated outcome measures such as the PROMIS Sleep Disturbance Scale and NIH Toolbox® Item Bank v3.0 – Perceived Stress survey(13210-MR: Overview Moon…)(Minimal Risk Citizen Sc…).
- Is the study built on what is known already?
- Yes. The study builds on existing anecdotal evidence and limited clinical evidence about the ingredients in MoonBrew, including magnesium, valerian root, chamomile flower, and L-Theanine, which are recognized for their potential benefits in improving sleep and reducing stress(13210-MR: Overview Moon…).
- Will the study provide meaningful answers to the research question?
- Yes. The study uses validated scales to measure sleep quality and stress, ensuring that the results will provide meaningful and scientifically valid answers about the effects of MoonBrew(13210-MR: Overview Moon…).
- Will the study provide valid answers to the research question?
- Yes. By employing a single-arm longitudinal design where participants act as their own controls and using validated outcome measures, the study is well-structured to provide valid answers to the research question(13210-MR: Overview Moon…)(Minimal Risk Citizen Sc…).
Non-maleficence
- Are participants recruited with justifiable inclusion and exclusion criteria?
- Yes. The study has clear inclusion and exclusion criteria to ensure participant safety, including exclusions for pregnant or breastfeeding women, individuals on blood thinners, those with known allergies to the ingredients, and individuals with autoimmune diseases(13210-Consent Moonbrew 1)(13210-MR: Overview Moon…).
- Does the research team have the experience, skills, facilities, and time to complete the study?
- Yes. Matthew Amsden, the Principal Investigator with significant technology efficiencies, along with the Efforia Staff have the necessary skills and facilities to conduct the study(13210-Consent Moonbrew 1)(13210-MR: Overview Moon…).
- Is there a fair balance of benefits and harms (risks) for all with an interest in the study?
- Yes. The potential benefits, such as improved sleep and reduced stress, outweigh the minimal risks, which are primarily mild and transient side effects. The study includes measures to monitor and address any adverse events promptly(13210-Consent Moonbrew 1)(13210-MR: Overview Moon…).
- Will participants receive appropriate care both during and after the study?
- Yes. Participants are informed about potential risks and are instructed to seek medical care if severe symptoms occur. They are also provided with contact information for support throughout the study(13210-Consent Moonbrew 1).
- Is personal data handled appropriately (confidentiality)?
- Yes. Efforia is committed to maintaining participant confidentiality, using encrypted data storage, and adhering to strict data protection protocols as outlined in their privacy policy(13210-Consent Moonbrew 1)(Minimal Risk Citizen Sc…).
Autonomy
- Have participants been offered a fair choice through the information they are given (presented in plain English) and consent process?
- Yes. The informed consent document provides clear and comprehensive information about the study, its risks, benefits, and the voluntary nature of participation, ensuring that participants can make an informed decision(13210-Consent Moonbrew 1)(Minimal Risk Citizen Sc…).
- Has the research incorporated patient and participant views?
- Yes. The study is designed to include feedback from participants regarding their experiences with MoonBrew, and the consent document encourages participants to ask questions and provide input throughout the study(13210-Consent Moonbrew 1)(13210-MR: Overview Moon…).
Justice
- Are there fair payments for participation and financial recompense in case of harm?
- Yes. While participants pay to participate, the study offers a valuable product (MoonBrew) and tracking of health outcomes, which provides intrinsic value. In case of adverse events, participants are instructed to seek medical care and report the incident to Efforia for further action. Patients understand medical care is their own financial responsibility. (13210-Consent Moonbrew 1).
- Do participants have access to an independent complaints procedure (or advocate)?
- Yes. Participants can contact Univo in the US or Efforia’s support for any concerns or complaints, ensuring they have an independent avenue for addressing issues(13210-Consent Moonbrew 1).
- Will the project be registered and results reported in the public domain?
- Yes. Efforia commits to transparency and plans to publish the study results on their website, contributing to broader scientific knowledge and public awareness(Minimal Risk Citizen Sc…).
AI Review Summary
Status:
Recommend Approval
Confidence:
- Private sector IRB: 90%
- Academic IRB: 85%
- European government ethics review board: 80%
Justification:
- Generally recognized as safe intervention: Yes
- There is some scientific merit to the intervention: Yes
- There is popular belief among some segments to the merit of the intervention: Yes
- Might be classified as adult content: No
- Intervention requires a blood draw more than twice per week: No
- Appears to be purposefully biased: No
- Addresses and understands study design limitations: Yes
- Is a longitudinal design: Yes
- Include any vulnerable populations: No
- Includes a design that does not attempt to answer the study hypothesis: No
- Targets populations with a disease state: No
- May bring up feelings of significant mental anguish (beyond a very bad day at work): No
- May involve illegal activities in certain jurisdictions: No
Respect for Persons:
The protocol includes informed consent with detailed information about the study, its risks, and the voluntary nature of participation. This respects the autonomy and dignity of participants by ensuring they can make an informed decision.
Beneficence:
The study aims to begin the process of creating scientific evidence on the benefits of MoonBrew for sleep and stress, while providing individual participant tracking of their experience with the protocol. The protocol also provides more systematic safety tracking than currently available. With potential positive outcomes for participants and the broader community under this preliminary study, more robust studies will be explored. The risk of harm is minimal, with side effects being mild and transient.
Justice:
The selection of participants is fair, targeting healthy adults interested in improving sleep quality and stress. The study does not disproportionately burden or exclude any particular group, ensuring equitable distribution of benefits and risks.
Equitability of Subject Selection:
Participants are selected based on general health criteria and interest in the study’s objectives, ensuring a diverse and representative sample. This approach prevents any group from being unfairly excluded or burdened by the study.
Risks to Subjects are Reasonable in Relation to Anticipated Benefits:
The risks, primarily minor side effects, are minimal and manageable compared to the potential benefits of improved sleep and reduced stress. The study’s design, with self-reported outcomes, ensures that any adverse effects are closely monitored and addressed.
PERSONA: PHARMACOLOGIST, BIASED AGAINST NON-PHARMA
Determination and Rationale for the 30-Day MoonBrew Sleep & Stress Study (13210-MR)
Review Summary
As a pharmacologist and IRB member with a bias towards pharmaceutical interventions and a critical view of the health and wellness industry, I have reviewed the 30-Day MoonBrew Sleep & Stress Study (13210-MR) under the Minimal Risk Citizen Science Umbrella Protocol. The study appears to be well-structured, with some methodological soundness and adequate safety measures. However, concerns about the scientific rigor and potential for placebo effects must be addressed. The study is suitable for conditional approval with specific recommendations.
Study Design and Methodology
- Intervention and Outcome Measures: The study involves participants consuming MoonBrew nightly for 30 days to assess its effects on sleep quality and stress levels. The primary outcome measures include the PROMIS Sleep Disturbance Scale and the NIH Toolbox® Item Bank v3.0 – Perceived Stress survey, which are appropriate and validated instruments. However, the study lacks a control group, which is critical for differentiating true effects from placebo effects.
- Methodology: The single-arm longitudinal design, where participants act as their own control, is a significant limitation. A placebo-controlled design would provide a more rigorous assessment of MoonBrew’s efficacy and help address concerns about placebo effects.
- Sample Size: The expected sample size of 600-1000 participants is adequate for generating meaningful data, assuming a low dropout rate.
Health Risks and Safety Measures
- Ingredient Safety: MoonBrew’s ingredients are generally recognized as safe (GRAS) under US law. The potential side effects, such as allergic reactions, gastrointestinal issues, and interactions with medications, are generally mild and transient. However, the product’s slightly elevated levels of lead, requiring a PROP 65 Warning under California Law, raise concerns about long-term safety.
- Exclusion Criteria: The study includes clear exclusion criteria to avoid risks to vulnerable populations (e.g., pregnant or breastfeeding women, individuals on blood thinners, those with known allergies to the ingredients, individuals with autoimmune diseases).
- Monitoring and Reporting: The study includes appropriate safety monitoring and reporting procedures. Participants are informed about potential risks and are instructed to seek medical care if severe symptoms occur.
Clinical Relevance and Scientific Rigor
While the study aims to provide evidence on the efficacy of MoonBrew in improving sleep quality and reducing stress, the lack of a placebo control group limits its scientific rigor. Given the study’s reliance on self-reported outcomes and the potential for placebo effects, the findings may not provide robust evidence for clinical recommendations.
Recommendations for Modifications
To enhance the scientific rigor and ensure the validity of the findings, the following recommendations are made:
- Incorporate a Placebo-Controlled Group: Implement a placebo-controlled design to differentiate the true effects of MoonBrew from placebo effects. This is essential for establishing the product’s efficacy.
- Objective Sleep Measures: Include objective sleep measurements (e.g., actigraphy) to complement self-reported data and validate outcomes.
- Enhanced Safety Monitoring: Given the presence of elevated lead levels, implement additional safety monitoring measures to assess any potential long-term health impacts.
Decision: Conditional Approval
The study is conditionally approved, with the requirement to incorporate a placebo-controlled group and implement additional safety monitoring measures. These modifications are essential to address concerns about scientific rigor and ensure participant safety.
Rationale
The study’s current design lacks the scientific rigor necessary to provide robust evidence for clinical recommendations due to the absence of a placebo control group and reliance on self-reported outcomes. By incorporating these recommendations, the study can better address potential placebo effects, ensure participant safety, and provide more credible evidence on the efficacy of MoonBrew.
Logging
Logging of:
- The protocol itself (any changes to measures, to the products, description to the anything else related to the protocol).
- Any changes to the products associated with the protocols
- Any changes to the measure associated with the protocols.