Take two BioBlue Capsules each morning and two each late afternoon or evening with water for 60 days.

Day 1: Baseline Fatigue Assessment. Weekly: Fatigue Assessment and Safety Check-in. Mitochondria Efficiency Test: Collect baseline specimen at the start and follow up during the study as instructed.

The Methylene Blue for Mitochondrial Function Study is designed as a single-arm observational trial where participants serve as their own control. This study, termed a "Signal Phase" study at Efforia, aims to investigate the effects of BioBlue Methylene Blue Supplements, which combine Methylene Blue and taurine, on mitochondrial function. The primary focus is to explore the potential of these capsules to enhance energy levels and mental clarity from a cellular perspective. By conducting this initial phase, the study seeks to gather preliminary indications of positive results and generate critical safety data, which is currently limited.

Participants in this trial will engage in a 60-day regimen, taking two BioBlue capsules each morning and two each late afternoon or evening. The study methodology emphasizes personalized outcomes by monitoring changes in the participants' energy and mental clarity. This approach allows for a nuanced understanding of how the intervention influences daily life, moving beyond generic assessments. The study's design includes baseline and follow-up evaluations using the mescreen™ Mitochondria Efficiency Test, which requires a small blood sample collected with a Tasso device. This non-invasive method ensures participant comfort while providing valuable data on mitochondrial efficiency.

Should the trial yield a positive signal, indicating the effectiveness of the intervention, more rigorous study designs will be considered for subsequent phases. This initial phase will help determine the feasibility of larger-scale studies and refine safety profiles for wider application. For more comprehensive details on this study, including specific methodologies and participant instructions, please refer to the "Minimal Risk Umbrella protocol."

Thank you for considering our submission for IRB review. The statistical plan for "The Methylene Blue for Mitochondrial Function Study" is aligned with the Minimal Risk Umbrella protocol. This ensures that all statistical methodologies and analyses adhere to predetermined guidelines designed to minimize risk while achieving robust scientific outcomes.

Our study involves the assessment of mitochondrial function and energy levels among adult participants using BioBlue Methylene Blue Supplements. We aim to evaluate changes in mitochondrial efficiency and fatigue levels using the mescreen™ Mitochondria Efficiency Test and the PROMIS Short Form v1.0 – Fatigue 8a.

For reviewers who wish to delve deeper into the specifics of our statistical plan, we encourage a review within the context of the Minimal Risk Umbrella protocol. This protocol provides comprehensive coverage of statistical considerations, including sample size calculations, data analysis techniques, and safety monitoring procedures, ensuring consistency and adherence to ethical standards.

We appreciate your attention to our study and look forward to your feedback. Should you have any questions or require further clarification, please do not hesitate to reach out.

The "Methylene Blue for Mitochondrial Function Study" is a single-arm observational trial aimed at exploring the efficacy of BioBlue Methylene Blue supplements on mitochondrial function and fatigue. While this design offers valuable initial insights, it inherently lacks a control group, which is a significant limitation as it may introduce bias and affect the validity of the outcomes. To mitigate this, the study incorporates an expectations questionnaire to assess and quantify participant bias, allowing researchers to consider how personal expectations might influence perceived changes in energy levels and mental clarity. This methodological adaptation is crucial in ensuring that the study's findings are as objective as possible within the confines of its design, setting a solid groundwork for more definitive research in the future.

Recognizing the limitations of the study's sample size and potential bias, the research design includes stratification by participant demographics to improve the robustness of data interpretation. By employing this statistical methodology, the study aims to control for confounding variables and accurately reflect the supplement's impact across diverse population subsets. This approach not only enhances the reliability of the findings but also supports the Minimal Risk Umbrella Protocol's mission to democratize clinical research by addressing diverse research questions often overlooked in traditional studies. The stratification strategy ensures that even within a single-arm trial, the heterogeneity of the sample is accounted for, allowing for more nuanced insights into the supplement's effects.

The study's primary goal is to act as a signal detection study, identifying potential benefits of BioBlue Methylene Blue on energy and mental clarity. If promising results are observed, these findings will pave the way for subsequent, more rigorous studies that include control groups and larger sample sizes to validate initial outcomes. This iterative research process aligns with Efforia's overarching objective of transforming curiosity into actionable insights, empowering participants to make informed decisions about their health and well-being. By adhering to the Minimal Risk Umbrella Protocol, the study not only contributes to the scientific discourse on mitochondrial function and supplements but also propels the democratization of research, ensuring that a broader spectrum of health inquiries is explored. For more detailed information on the study's framework and ethical considerations, individuals are encouraged to refer to the Minimal Risk Umbrella Protocol.