50 Day
The effects on sleep quality of 1:4 Reishi liquid extract
| STUDY TITLE | The effects on sleep quality of 1:4 Reishi liquid extract |
|---|---|
| Submitted under umbrella | |
| Date submitted |
Sep 3, 2025 |
| 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 |
Darci Gross, Emma Roberts, Matthew Amsden |
| Principal investigator |
Matthew Amsden |
| Sub-Investigator for Adverse Events |
Dr. Viral Patel |
| Description |
Examining the effects of 1ml of Reishi mushroom extract (1:4 extraction ratio, two hot water extractions and an alcohol extraction), taken daily, 30 mins before bed on perceived sleep quality and stress levels. Sleep quality includes: duration, sleep onset latency, nighttime wakings, and perceived restfulness. And consequently, the potential for increased daytime energy levels and a reduction in perceived stress levels. |
| Participant engagement length |
50 Days |
| Sponsor |
This study is made possible by your payment to cover all supplies and expenses required to participate. |
| Cost to participant |
$35 |
| Included products & services |
Organic Reishi Tincture: $35
|
| Outcome measures |
PROMIS Sleep Disturbance Scale Neuro-QOL Item Bank v1.0 –Fatigue – Short Form Neuro-QOL Item Bank v1.0 –Fatigue – Short Form Perceived Stress Scale (Past Week Version) |
| 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:
The buzz around Reishi mushroom's mythical sleep-enhancing properties is hard to ignore. Social media teems with glowing anecdotes while scholarly research hints at Reishi's potential in modulating stress and sleep. Yet, hard evidence remains elusive. This study aims to explore the effects of a 1:4 Reishi liquid extract on sleep quality metrics and stress levels. With sleep disorders and stress rampant, it's crucial to assess if this ancient remedy holds the key to better slumber and serenity.
My Objective for You:
By participating, you'll unlock personalized insights into how Reishi tincture impacts your sleep and stress. Our goal is to see if this natural extract can enhance your sleep duration, reduce nighttime interruptions, and improve your overall restfulness, while simultaneously lowering stress. You'll gain data-driven results that empower you to make informed decisions about your sleep health and lifestyle choices moving forward.
Aims & Objectives:
This study aims to scientifically evaluate the impact of Reishi extract on participants' sleep quality and stress levels. Participants will receive personalized insights into how the tincture affects their unique sleep patterns and stress, helping them make informed decisions about incorporating such natural supplements into their wellness routine.
Significance & Impact:
This study could redefine how we perceive and utilize natural sleep aids, with the potential to substantiate Reishi's role in improving sleep quality and reducing stress. While results may vary and limitations exist, participants stand to gain valuable, personalized data that could revolutionize their approach to achieving restful sleep and managing stress, contributing to enhanced daytime energy and overall well-being.
The Intervention
Included Products & Services
Product Name: Organic Reishi Tincture
Quantity included: 30
Price: $35.00
Product Description: UK-grown organic Reishi tincture, cloned in our lab and extracted in the tincture kitchen on our mushroom farm in Somerset. We are the only organic certified UK-native functional mushroom producer currently in the UK. What makes Bristol Fungarium's Reishi tincture unique? 100% Organic Certified The only UK-grown organic certified Reishi Mushroom Tincture. All our mushrooms are grown on an organic mushroom farm in the green county of Somerset UK, and are certified by the Soil Association. Our organic functional mushroom tinctures are triple extracted with distilled water and organic UK ethanol. Grown in Somerset, UK Our Reishi is grown on our organic mushroom farm, where we crop almost half a ton per month. We also prepare the tinctures and pack the orders in-house - meaning origin can be traced back to one location in the clean green pastures of Somerset with absolutely no tampering by third parties. Triple Extracted, 1: 4 Ratio (Super Strength) We carry out two hot water extractions and a final organic ethanol extraction to gain access to all the bioactive compounds responsible for Reishi’s beneficial properties. Many capsules and supplements are shipped across the world in powder form as it is a more commercially viable way of transporting extracted products. However, our tinctures are prepared on-site at a 1:4 ratio (1g of mushrooms to every 4ml of water). Tinctures have a longer shelf life than capsules, provide a faster absorption rate, enable flexible dosage, and are easy to prepare by simply taking one squeeze of mushroom tincture twice per day either directly under the tongue or into a short glass of water. Fully Transparent & Short Supply Chain Each bottle of our organic Reishi tincture contains 128g of Reishi fruiting body*. Because our supply chain is so much shorter, and we prepare our tincture in comparatively small batches, you can be sure that the extracts you buy from us haven't lost bio-active compounds due to sitting around for a long time or being shipped halfway across the world. *fresh value Bottle size: 50ml We recommend speaking with a qualified medical practitioner if you are on any medication and unsure of how it may interact.
Product Image:
Ingredients:
Product Safety:
Study Design & Methodology
Inappropriate Participants & Inclusion/Exclusion
Under the Efforia minimal risk protocol, within which this study is reviewed for safety and human subjects ethics, all individuals over the age of consent are eligible, however, it is the responsibility of participants to determine if their unique circumstances make participation inappropriate.
Here's a table identifying individuals who should avoid or seriously consider whether the study is right for them:
| Category of Individual | Contraindications | Reason |
|---|---|---|
| Individuals with Allergies | Known allergy to mushrooms or similar fungi | Risk of allergic reactions, which could be severe and include symptoms like rash, swelling, or anaphylaxis. |
| Pregnant or Nursing Women | Pregnancy or breastfeeding | Limited data on safety in pregnancy or lactation, potential risk to the infant or fetus. |
| Individuals on Anticoagulants | Use of blood-thinning medication | Reishi mushroom may interact with anticoagulants, increasing the risk of bleeding. |
| Immunocompromised Individuals | Compromised immune system | Potential for adverse effects due to modulation of immune pathways, which may affect health. |
| Individuals with Liver Disease | Existing liver conditions | Potential liver interactions, as some mushrooms can affect liver enzymes and function. |
| Children and Adolescents | Underage participants | Insufficient data on safety and efficacy in developing bodies, requiring more caution. |
| Individuals with Chronic Illnesses | Chronic health conditions | Underlying conditions may be exacerbated by supplement interactions or stress modulation. |
| Those with Mental Health Disorders | Diagnosed mental health issues | Potential impact on neurotransmitters and stress pathways, which may affect mental health stability. |
Participants should carefully evaluate these factors and consult with a healthcare provider to determine if participation is suitable for their situation.
Study Design & Experience
Daily Activity: Incorporate 1ml of Bristol Fungarium's Organic Reishi Tincture into your bedtime routine, consumed directly under the tongue or mixed into a small glass of water, about 30 minutes before bedtime.
Assesments and frequency:- Baseline: Complete the Baseline PROMIS Sleep Disturbance Scale, Baseline Neuro-QOL Fatigue Short Form, and Baseline Perceived Stress Scale.
- Follow-Up: Complete the Follow-Up PROMIS Sleep Disturbance Scale, Follow-Up Neuro-QOL Fatigue Short Form, and Follow-Up Perceived Stress Scale.
The study titled "The effects on sleep quality of 1:4 Reishi liquid extract" aims to investigate the influence of a daily regimen of Reishi mushroom extract on various facets of sleep quality and stress levels. Specifically, this observational trial will assess how 1ml of Reishi extract, taken 30 minutes before bedtime, affects parameters such as sleep duration, sleep onset latency, nighttime awakenings, and perceived restfulness. Additionally, the study will explore potential improvements in daytime energy levels and reductions in perceived stress. Conducted as a single-arm trial where participants serve as their own control, this "Signal Phase" study at Efforia seeks to provide a preliminary directional indication of positive results concerning the Reishi extract's efficacy on enhancing sleep quality and reducing stress.
The methodology of this study involves participants incorporating 1ml of Reishi extract into their nightly routine over a 40-day period, allowing researchers to collect data on its effects. This trial format is designed to capture any positive signals in the observed outcomes, which could warrant further investigation through more robust study designs. Participants will be closely monitored for changes in sleep and stress-related outcomes using validated scales such as the PROMIS Sleep Disturbance Scale, Neuro-QOL Fatigue Short Form, and the Perceived Stress Scale, both at baseline and follow-up. This trial is particularly valuable as it promises to generate initial safety data on the Reishi extract that is currently not well-documented, thereby contributing to its safety profile.
Participants in this study will be guided through a structured experience, beginning with an introduction to the trial's objectives and practical instructions for integrating the Reishi tincture into their bedtime regimen. They are advised to maintain consistency in their supplement intake, avoid additional supplements, and report any changes or adverse effects to the study team. The study emphasizes participant safety and data integrity, ensuring that personal health takes priority and that any side effects are promptly addressed. Overall, this trial represents a collaborative effort between Efforia and Bristol Fungarium to explore the historical claims of Reishi's benefits in a contemporary scientific context, potentially paving the way for more comprehensive future research. For more detailed information, please refer to the Minimal Risk Umbrella protocol.
Expected sample size: See page 92 of the Minimal Risk Citizen Science Protocol. There will be no change to the statistical analysis plan for this study.Dear IRB Reviewers,
We are submitting our protocol titled "The effects on sleep quality of 1:4 Reishi liquid extract" for your review. This study examines the impact of a daily dose of Reishi mushroom extract on perceived sleep quality, stress levels, daytime energy, and fatigue. The measures deployed include the Perceived Stress Scale, the Neuro-QOL Item Bank for Fatigue, and the PROMIS Sleep Disturbance Scale, all assessing outcomes before and after the intervention.
Our statistical plan aligns with the Minimal Risk Umbrella protocol, under which this study is categorized. This ensures that all statistical methodologies, including data analysis plans and sample size considerations, adhere to the established guidelines to minimize risk and uphold participant safety. If there is a need for further scrutiny of our statistical plan, we encourage reviewers to examine these elements within the context of the Minimal Risk Umbrella protocol, where detailed explanations and justifications are provided.
We appreciate your attention to this submission and look forward to your feedback.
Statistical Analysis Plan
Limitations & Justification
The study titled "Exploring the Effects of Reishi Mushroom Extract on Sleep Quality and Stress Levels" is designed under the Minimal Risk Citizen Science Umbrella Protocol as a single-arm observational trial, which inherently carries certain limitations. The absence of a control group in this design increases the risk of bias, as it is challenging to differentiate the effects of the Reishi mushroom extract from placebo effects or other external factors. To address this, we incorporate an expectations questionnaire to quantify participants' biases and expectations regarding the extract's effects, thus allowing us to contextualize the results more accurately. By understanding the influence of participant expectations, we can better assess the true impact of the Reishi extract on sleep and stress.
Further, the study carefully considers sample size and statistical methodologies, including potential stratification by participant demographics, to enhance the robustness of our findings. Stratification helps ensure that our sample reflects a diverse population, thus allowing for more generalizable results despite the limitations of a single-arm trial. Importantly, this study serves as a signal detection effort, where initial positive findings could justify more rigorous follow-up studies with robust designs, such as randomized controlled trials, to validate and expand upon these initial insights. This pragmatic approach ensures that any promising effects of Reishi extract observed in this exploratory study can be rigorously tested in subsequent research.
In alignment with Efforia's goal of democratizing clinical research, this study aims to address research questions and support researchers who might otherwise be overlooked. By providing personalized insights into how Reishi extract affects individual sleep patterns and stress levels, participants gain valuable data that empower them to make informed decisions about their health. This approach not only contributes to the body of knowledge regarding natural sleep aids but also democratizes the research process by involving participants in meaningful ways. For more information on our methods and rationale, individuals are encouraged to consult the Minimal Risk Umbrella Protocol.
Human Subjects Ethics
Suitability Under Minimal Risk Umbrella Protocol
The protocol examining the effects on sleep quality of a 1:4 Reishi liquid extract appears to be suitable for inclusion under the minimal risk umbrella protocol. The study focuses on a non-regulated dietary supplement, Reishi, which is considered "Generally Recognized as Safe" (GRAS) in many jurisdictions. This aligns with the umbrella protocol's qualification for studies within the "health and wellness" domain. The intervention does not require a prescription or physician diagnosis and is designed to enhance general health and wellness, specifically targeting sleep quality, which is a common wellness concern. As the study involves a legal, easily accessible intervention, it satisfies the requirement for examining interventions without a prescription in the research jurisdiction.
Additionally, as the protocol does not involve vulnerable populations, medical devices, pharmaceuticals, or interventions requiring regulatory approval, it adheres to the restrictions set by the umbrella protocol. The study is unlikely to involve blinding, deception, or more than two blood draws, as it focuses on a dietary supplement's impact on sleep. Assuming the study is longitudinal in nature, lasting several days, and does not incorporate any elements listed as unsuitable—such as targeting vulnerable populations or involving regulated interventions—it fits within the minimal risk criteria outlined. Therefore, this protocol is suitable for the Efforia platform, assuming all other necessary ethical and scientific standards are met.
Suitability for Pay to Participate Model
In reviewing the study "The effects on sleep quality of 1:4 Reishi liquid extract," it is appropriate to allow participants to pay for the Organic Reishi Tincture at the price of $35. The Reishi mushroom extract, as described, is a specialized product that is legally available on the open market in the UK. Consumers are generally willing to pay for health supplements like Reishi due to their purported benefits in enhancing sleep quality and reducing stress. The price of $35 is competitive when compared to similar Reishi extracts available in the market, some of which may be priced similarly or even higher, depending on their extraction process and concentration.
Moreover, the inclusion of the Organic Reishi Tincture in this research study provides additional value beyond mere purchase convenience. Participants are not only obtaining a product that can be used independently but are also gaining access to expert tracking and analysis of its effects on sleep and stress, which enhances the overall value proposition. The typical target market for such supplements, generally health-conscious consumers, can cover the cost without incurring serious financial hardship. Furthermore, there are no severe and acute participant vulnerabilities identified in the study that would likely lead to significant buyer's remorse. The study's structure ensures that participants are informed and empowered to make decisions based on comprehensive information, supporting their autonomy and minimizing the risk of exploitation.
Human Subjects Protection Questionnaire
Beneficence
Is there a description, unambiguous research question, and purpose? Yes, the study has a clear research question and purpose that focus on evaluating the effectiveness of a product or service that participants have already purchased. The study is designed to gather data on the outcomes and impacts of the product or service, providing valuable insights for both participants and researchers.
Is the study built on what is known already? Yes, the study leverages existing knowledge and research regarding the product or service being evaluated. It aims to add to the current body of evidence by collecting real-world data from participants who have firsthand experience with the product or service.
Will the study provide meaningful answers to the research question? Yes, the study will provide meaningful answers by collecting data directly from participants who are already using the product or service. This approach ensures that the results are not only generalizable but also directly relevant to the experiences of the participants involved.
Will the study provide valid answers to the research question? Yes, the study's design, which includes direct feedback from participants, ensures the validity of answers to the research question. By using real-life data from actual users of the product, the study is well-positioned to produce credible and reliable outcomes.
Non-maleficence
Are participants recruited with justifiable inclusion and exclusion criteria? Yes, any individual who has already purchased the product is eligible to participate. Efforia emphasizes participant responsibility in identifying if the protocol is not right for them through clear risk disclosures and considerations outlined in the informed consent document.
Does the research team have the experience, skills, facilities, and time to complete the study? Yes, the research team is well-equipped with the necessary skills and infrastructure, as the studies are decentralized and involve minimal patient interaction. Efforia's platform supports these efforts with oversight from experienced professionals, including Principal Investigator Matthew Amsden and Dr. Viral Patel, who can address adverse events if they occur.
Is there a fair balance of benefits and harms (risks) for all with an interest in the study? Yes, the study's unique approach, as outlined in the minimal risk protocol, provides additional value to participants who have purchased the product or service at no extra cost. The minimal risk nature of the study ensures that the potential benefits outweigh any risks.
Will participants receive appropriate care both during and after the study? Yes, participants are advised to seek their own medical care in the event of an adverse event, as per the informed consent. However, the research study offers enhanced care through adverse event monitoring, which is often lacking for these open-market interventions.
Is personal data handled appropriately (confidentiality)? Yes, personal data is managed according to the guidelines set forth in the Minimal Risk Umbrella protocol, ensuring participant confidentiality and data protection.
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 comprehensive and clear information about the study, its risks, benefits, and voluntary nature, allowing participants to make informed decisions.
Has the research incorporated patient and participant views? Yes, Efforia's platform is participant-driven, ensuring that the study incorporates feedback from participants regarding their experiences. The consent document encourages ongoing communication, allowing participants to ask questions and provide input throughout the study.
Justice
Are there fair payments for participation and financial recompense in case of harm?
Yes, while participants pay to participate, they receive a valuable product and health outcome tracking, which provides intrinsic value. Participants are informed to seek medical care at their own expense in case of adverse events and report incidents to Efforia for further action.Do participants have access to an independent complaints procedure (or advocate)?
Yes, participants have access to Efforia's support for addressing concerns or complaints. Additionally, the informed consent includes contact information for independent ethics review boards, offering an alternative avenue for addressing issues.Will the project be registered and results reported in the public domain? Yes, Efforia commits to transparency by making personal results immediately available to participants and aims to publish generalizable results to build credibility, ensuring the study's findings are accessible to the public.