Important Information
Summary Information to Help you Decide Whether to Join this Study
| Study Title | The Methylene Blue for Cellular Health Study |
| Principal Investigator | Dr. Mike Belkowski, Founder BioLight with Support from Matthew Amsden and Dr. Viral Patel |
| Sponsor | This study is made possible by your payment to join. |
| Cost of Products, Services & Information to Participant | $599 (note: you may have already paid for some or all of this amount) |
| Included Products & Services | BioBlue Capsules | Methylene Blue Supplement – Support Brain Health & Mitochondrial Function | Red Light Therapy Synergist – USP Grade (60 capsules; 2 capsules twice daily for 60 days) GlycanAge Test Kit (2 finger-prick samples; baseline & day 60; at-home collection with lab analysis and report) |
| Outcome Measures | PROMIS Short Form v1.0 – Fatigue 8a (self-report) GlycanAge Biological Age Test (IgG glycan profiling) |
| Contact | help@efforia.com |
👍 The table above provides a summary. You may sign now and continue, or read more detail below.
Introduction & Summary
Welcome to this citizen science research study hosted on the Efforia platform. You are being invited to participate in The Methylene Blue for Cellular Health Study. This study evaluates whether BioBlue Methylene Blue Capsules (USP-grade methylene blue combined with taurine) may influence energy and fatigue and is designed to explore changes in biological age measured by GlycanAge. Your participation is voluntary. You may leave the study at any time without penalty or loss of benefits to which you are otherwise entitled. Please review all sections carefully, and ask any questions you have before deciding to proceed.
Efforia is a citizen science platform where studies are effectively sponsored by you, the participants. Unlike traditional research studies, you pay for all the supplies, services, information, and tools needed for participation in one transaction. This makes studies possible that might not be otherwise.
Although you could buy these products and services separately for a similar cost, Efforia bundles them into one purchase for convenience. Efforia organizes these items and provides instructions to create a comprehensive, data-driven research experience. This setup allows you to track and understand the impact on your own life via detailed outcome reports, making informed personal health decisions easier. It also advances broader research findings, benefiting others who might not afford such purchases without guaranteed results.
Efforia is committed to equitable inclusion. If the cost is too high for you, click the large Efforia logo at the top of the screen to explore other protocols. Efforia offers protocols on various topics at different price points, including free options, so you can find one that suits your goals and budget.
Purpose of the Study
This study aims to assess whether BioBlue Methylene Blue Capsules can influence self-reported fatigue (via PROMIS Short Form v1.0 – Fatigue 8a) and biological age (via the GlycanAge Biological Age Test). BioBlue combines USP-grade methylene blue (10 mg/day in two 2-capsule doses) and taurine (500 mg/day) in vegetarian capsules (HPMC). Methylene blue has historical medical uses and is being explored at low doses for mitochondrial and cognitive support. Taurine supports cellular osmoregulation and antioxidant activity. The GlycanAge test measures IgG glycosylation patterns linked to chronic inflammation and aging, providing a biomarker that may shift with lifestyle or intervention changes. Findings may help you make informed personal health decisions and contribute to broader knowledge on mitochondrial function and cellular aging.
What You Will Do as Part of this Study
While participating in this research study, you will need to:
- Be willing and able to follow the study directions and procedures
- Tell Efforia about any side effects or problems by communicating with help@efforia.com or online chat.
- Ask questions as you think of them, via help@efforia.com or online chat.
- Inform Efforia if you change your mind about staying in the study. You may leave the study at any time by communicating with help@efforia.com or chat.
After completing enrollment and payment, and providing your personal details, shipping details, and communication preferences, your study experience will include:
- Study length: 60 days.
- Intervention: Take two BioBlue capsules each morning and two in the late afternoon/evening (total four capsules daily) with water.
- Assessments: Complete a baseline fatigue survey on Day 1, weekly fatigue assessments with safety check-ins, and GlycanAge finger-prick blood collections at baseline and around Day 60.
- Methodology: Single-arm longitudinal design where you act as your own control; results are compared over time.
- Support: Report side effects or concerns via help@efforia.com or in-app chat; ask questions as needed.
The Risks, Discomforts & Benefits of Being in this Study
There are some unique risks, discomforts, and potential benefits you should understand before joining.
Possible Serious Adverse Events & Side Effects
| Risk name | Risk likelihood | Summary |
| Serotonin syndrome (with SSRIs/MAOIs) | Medium | Methylene blue may interact dangerously with SSRIs or MAOIs; participants on these drugs should not join. |
| Hemolytic anemia (G6PD deficiency) | Low | Methylene blue can trigger hemolysis in individuals with G6PD deficiency. |
| Mood changes / mood swings | Low | Potential exacerbation of existing mood disorders or induction of mood instability. |
| Cognitive changes | Low | Potential confusion, difficulty concentrating, or other cognitive effects. |
| Gastrointestinal upset | Low | Possible nausea, stomach discomfort, or vomiting. |
| Allergic reactions | Low | Hypersensitivity to ingredients may cause rash, itching, or other reactions; discontinue and seek care. |
| Urine discoloration | Very high | Blue/green urine is expected and harmless with methylene blue. |
Some People May be at Increased Risk
Some people may be at increased risk from this study and should not join before speaking with a medical or other professional who knows your specific circumstances. Without such approval, Efforia strongly encourages you not to join the study or use the associated product and services outside the study.
| Who | Why they should not join |
| Pregnant, thinking of becoming pregnant, or breastfeeding | Potential risks to the fetus or nursing infant are unknown and may be harmful. |
| Individuals on SSRIs or MAO inhibitors | Risk of serotonin syndrome with methylene blue. Participants on SSRIs should not join this study or use this product. |
| Individuals with G6PD deficiency | Risk of hemolytic anemia. |
| People with mood disorders | Potential exacerbation of mood instability or mood swings. |
| Individuals with cognitive impairment | Possible worsening of confusion or concentration difficulties. |
| Individuals with gastrointestinal sensitivities | Possible nausea, stomach discomfort, or vomiting. |
| Cancer patients or survivors | Theoretical risk related to cancer incidence (likelihood considered low but uncertain). |
| People with known allergies to listed ingredients | Risk of allergic reactions to supplement components. |
Consider your Own Risk–Benefit Comfort Level
We encourage you to weigh carefully the potential risks and benefits based on your personal health history, medications, and preferences. This study places more responsibility on you to make the right choice than a traditionally sponsored trial.
It is possible that not all risks and benefits are currently known. Participants have the responsibility to consult with their healthcare providers and conduct further research before enrolling in the study.
Privacy & Security Risks
We work hard to keep your data private and confidential, but there is no such thing as zero risk. Please review the Efforia Privacy Policy here: https://efforia.com/privacy-policy/
- We may contact local help if we have reason to believe you may be a harm to yourself or others.
- Regulators (e.g., FDA or similar), or Institutional Review Boards, may review identifiable records to ensure the study is done properly.
The Possible Benefits of Participating — Personal and Overall Findings
Efforia will provide you with both personal outcomes and aggregated findings. These may be made available at various data collection points or as they are discovered. Results may affect your interest in and willingness to remain in the study; participation is voluntary and you may exit at any time by emailing help@efforia.com.
There is a possibility that there will be no measurable benefit to you, other than seeing reports that the intervention had no measurable impact.
What to do if you have a study related injury
Seek local medical care first if necessary. Efforia cannot provide emergency medical care or diagnosis. After receiving any necessary treatment, please contact Efforia regarding any problems, side effects, or study-related injuries so that we can record the event and help inform others of potential risks (email help@efforia.com).
Study related injury care and compensation
Efforia will not offer financial compensation nor absorb the costs of medical treatment should you be injured as a result of participating in this research. Efforia makes no commitment to provide free medical care or payment for any study related injury as a result of participation in this study.
In the case of medical emergency
In the case of medical emergency, please dial 911 immediately. Do not attempt to contact Efforia until after the emergency has passed. Access local in-person medical assistance immediately.
If at any time you feel like you may be a danger to yourself or others, please dial 988 for the National Suicide & Crisis Lifeline. Help is available.
Alternatives to Participating in the Study
Because this is research, the primary alternative is that you may choose not to participate. If this study does not seem quite right, or is too expensive for your purposes, you can click the Efforia logo at the top of the page to browse other studies at various price points, including free options.
Your Rights as a Participant
Ethical Considerations: Efforia upholds high ethical standards in research, similar to those used in pharmaceutical and academic studies, even though Efforia hosts (and does not sponsor) these studies. Your participation is completely voluntary, and you are free to withdraw at any time without adverse consequences. You are not giving up any rights by signing this document.
Privacy and Confidentiality
You have a right to privacy and confidentiality in this research. Your personal information is protected through measures designed to ensure anonymity or confidentiality. All data processing is designed to safeguard personal data against unauthorized access and misuse.
Right to Your Own Results
You have the right to a complete explanation of the research once your involvement concludes, particularly if the study involves any form of deception such as placebos or controls. Where applicable, your personal results will be available within your Efforia account, and aggregate findings may be shared by the study team.
The Right to Leave a Study without Penalty at Any time
If you decide to withdraw, you can do so at any time by visiting your Profile → Your Protocols → Leave. You will be refunded for any consumable products that have not yet been shipped. For non-consumable products, a full refund will be issued upon their return in accordance with our return policy.
Participant Rights
Your participation in this research study is voluntary. Refusing to participate will not alter your usual health care or involve any penalty or loss of benefits to which you are entitled. If you decide to join the study, you may withdraw at any time and for any reason without penalty or loss of benefits.
New Information and study results
If information generated from this study is published or presented, your identity will not be revealed. In the event new information becomes available that may affect the risk or benefit associated with this study or your willingness to participate in it, you will be notified so that you can decide whether or not to continue participating.
Confidentiality & Privacy
The researchers will only use and share information that is needed for the study. The researchers will protect your information, as required by law. Absolute confidentiality cannot be guaranteed because persons outside the study team may need to look at your study records. The Efforia Institutional Review Board may review your study records, and other agencies, committees, and offices that review and monitor research studies. The purpose for using and sharing your information is to make sure the study is done properly.
By signing this consent form, you are giving permission for Efforia to use and share your health information. If you decide not to sign the form, you cannot be in the study.
Participant Rights (restated)
Your participation in this research study is voluntary. Refusing to participate will not alter your usual health care or involve any penalty or loss of benefits to which you are entitled. If you decide to join the study, you may withdraw at any time and for any reason without penalty or loss of benefits.
New Information and study results (restated)
If information generated from this study is published or presented, your identity will not be revealed. In the event new information becomes available that may affect the risk or benefit associated with this study or your willingness to participate in it, you will be notified so that you can decide whether or not to continue participating.
Confidentiality & Privacy (restated)
The researchers will only use and share information that is needed for the study. Researchers will protect your information, as required by law. Absolute confidentiality cannot be guaranteed because people outside the study team may need to look at your study records. Efforia Institutional Review Board may review your study records, and other agencies, committees, and offices that review and monitor research studies. The purpose of using and sharing your information is to make sure the study is done properly.
Signing this consent form, you are giving permission for Efforia to use and share your health information. If you decide not to sign the form, you cannot be in the study.
Conflict of Interest Statement
As part of our commitment to ethical conduct and transparency in this citizen science clinical trial, it is essential to disclose the unique structure of this study. This trial is hosted by Efforia, but it is uniquely sponsored by you, the participants. Efforia serves solely as the platform provider and does not sponsor or influence the study outcomes.
How Efforia Makes Money on this protocol: Efforia takes a transaction fee on the products and services included in this protocol. Otherwise, Efforia has no financial interest in, or conflict of interest with, the outcomes. To further reduce conflicts of interest, if you do not complete enrollment, you will be reminded once. We will not remarket to you nor otherwise push you to join.
How we Reduce Conflicts of Interest
Participants must not have any financial relationship with the intervention or measurement providers used in this trial. You should not be an employee, investor, stakeholder, or protocol author associated with these entities. Such conflicts could compromise the integrity and validity of the results.
Consequences of Conflict of Interest Non-Compliance
Failure to disclose such a conflict of interest, or discovery of such a breach, may result in immediate suspension from the platform, and payments may not be refunded.
By joining this trial, you affirm that you understand the above conflict of interest restrictions and agree to comply fully with them. Your participation is valued, and your adherence to these guidelines ensures the validity and reliability of our collective scientific efforts.
Data Protections
We collect study data that you submit (e.g., surveys, logs), device/lab data you connect (e.g., GlycanAge results), and basic account details necessary to operate the study. Data are used to show you your personal results and to generate aggregated findings. We apply technical and organizational safeguards to protect your data and comply with applicable data protection laws. Additional details are available in the Efforia Privacy Policy: https://efforia.com/privacy-policy/
What you can do to improve your privacy and security
As part of participating in this study, you will receive notifications via e-mail, SMS, or push notification when new study tasks like questionnaires and reminders are ready for you. You can adjust your communication preferences in the Efforia application at any time. If you do not want to receive notifications from this study, do not press the Accept button. You can decide not to join this study, and will not receive notifications. To ensure others don’t see these alerts, make sure your phone or desktop computer and e-mail accounts are protected by a password, PIN, or other access control. Do not share your accounts or passwords. Because this study is hosted in Efforia, it is governed by privacy and confidentiality standards that put you, as a participant, in control. Learn more here: https://efforia.com/privacy-policy/
Who will have access to your data?
Efforia will have access to your data for study operations, safety, and analysis. Select partners (e.g., labs processing your samples or connected health device providers) may also access relevant data to deliver their services.
What will we do with your data?
We will use your data to display your personal results and to combine it with other participants’ data to produce general outcomes. We will not use information connected with your name or other direct identifiers for public reporting without your permission.
California Experiential Research Subject’s Bill of Rights
If you are a California resident participating in research, you have specific rights recognized under California law, including the right to ask questions and to be informed of risks, benefits, and alternatives. For more about your privacy and related protections while using Efforia, visit the Efforia Privacy Policy: https://efforia.com/privacy-policy/. You may request additional information or a copy of the Research Subject’s Bill of Rights by contacting the IRB (see below).
Questions or Concerns
This study has been reviewed by the Efforia Institutional Review Board (IRB), a group of independent experts who help protect the rights, safety, and well-being of research participants.
If you have questions about your rights as a participant, or would like to speak with someone outside the research team, you can contact the IRB at ethics@efforia.com
ETHICS@EFFORIA.COM
Additional questions and closing
Efforia has approved the information in this consent form and have given approval to publish this study. This does not mean Efforia has approved or endorses you being in the study. You must consider the information in this consent form and do additional research based on your own situation for yourself and decide if you want to and are appropriate for this study.
If you have questions, please contact help@efforia.com. It is up to you to do additional research and talk to your physician before joining a study.
Additional Study-Specific Information
- Protocol category: Minimal Risk Citizen Science Umbrella Protocol (hosted on Efforia)
- Design: Single-arm longitudinal (participants act as their own control)
- Registration: The authors commit to listing and reporting findings on ClinicalTrials.gov where applicable.
- Dissemination plan: Basic (aggregate outcomes shared without personal identifiers)
- Language: English
- Participant engagement length: 60 days
- Prepared with the assistance of AI and reviewed by a human.