70 Day
MyVitalC: Sleep & Everyday Headache Management
| STUDY TITLE | MyVitalC: Sleep & Everyday Headache Management |
|---|---|
| Submitted under umbrella |
|
| Date submitted |
May 25, 2026 |
| 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 | |
| Informed consent | |
| Study author |
Chris Burres, Darci Gross, Matthew Amsden |
| Principal investigator |
Matthew Amsden |
| Sub-Investigator for Adverse Events |
Dr. Viral Patel |
| Description |
Test the potential benefits of MyVitalC ESS60 in Olive Oil on sleep quality and frequent headache management over six weeks for yourself. Participants will take a daily dose of MyVitalC's ESS60 in Olive Oil, aimed at improving sleep quality and reducing everyday headache frequency and severity. The protocol will allow participants to share their personalized experiences and data on social media (optional). |
| Participant engagement length |
70 Days |
| Sponsor |
This study is made possible by your payment to cover all supplies and expenses required to participate. |
| Cost to participant |
$218 |
| Included products & services |
2 Bottles – ESS60 in Organic Extra Virgin Olive Oil Efforia: $218
MyVitalC Gift Card: $218
|
| Outcome measures |
PROMIS Sleep Disturbance Scale PROMIS Bank v1.1 – Pain Interference Weekly Headache Check-In (Past 7 Days) |
| 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 |
| Commitment 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 we created this Real Life Trial
Sleep and headaches can quietly wreck your mood, energy, and productivity. You may have heard claims in wellness circles that MyVitalC (ESS60 in extra virgin olive oil) supports better sleep and fewer headaches. Instead of relying on hype—or dismissing it—we’re giving you a simple way to test it in your real life and see what actually changes for you.
We’ll use the PROMIS Sleep Disturbance Scale plus short, consistent weekly headache check-ins to turn your experience into clear before/after insights.
Our objective for you
This is about your outcome—not an average across a crowd.
By the end, you’ll have a personal results summary that helps you answer questions like:
- Did your sleep disturbance improve, worsen, or stay the same?
- Did your headaches become less frequent or less severe?
- Are any changes big enough to matter in day-to-day life?
You’re not just “enrolled”—you’re running a structured experiment on yourself, with an easy tracking system that turns your daily routine into evidence.
Aims & what you’ll get back
This study has an innovative design. We're going to be collecting four weeks of baseline data. Then you'll start using MyVitalC, and continue for another 6 weeks with weekly assessments.
What we’re measuring:
- Headache frequency (how many you had each week) as compared to an average of our four week baseline.
- Headache severity (how bad the worst one was, using your weekly rating scale) as compared to an average of our four week baseline.
- Sleep quality (via PROMIS Sleep Disturbance) as compared to an average of our four week baseline.
What you receive:
- A clear baseline vs. during-use comparison
- A simple readout of your trend over time
- A practical takeaway: whether MyVitalC seems worth continuing based on your own data
Why this matters
Even if results vary from person to person, your data won’t be vague. You’ll walk away with something most wellness purchases never provide: evidence that reflects your body, your lifestyle, and your results.
This Real Life Trial is designed to help you make a confident decision—based on what happened for you—not what anyone claims should happen.
The Intervention
Included Products & Services
Product Name: 2 Bottles – ESS60 in Organic Extra Virgin Olive Oil Efforia
Quantity included: 48
Price: $218.00
Product Description: 2-bottle package for Real World TrialMyVitalC ESS60 in Organic Extra Virgin Olive Oil, 120ml MyVitalC ESS60 in Organic Extra Virgin Olive Oil, 1 bottle contains 120ml ~.8 mg/ml of ESS60 in Organic Extra Virgin Olive Oil. THE SECRET IS OUT AND THOUSANDS ARE ENJOYING THE BENEFITS: Our proprietary manufacturing processes are bringing to market what many have called the miracle molecule, ESS60. The scientist who discovered this miracle molecule won the Nobel Prize in 1996 and now you have access to the molecule with properties of an Antioxidant 172Xs more powerful than VITAMIN C combined with the anti-inflammatory oil associated with the LIFE EXTENDING Mediterranean Diet. SLEEP: According to the New York Times bestselling book “Why we Sleep: The New Science of Sleep and Dreams” by bestselling author Matthew Walker: With $2 billion sleep aid industry most “sleep aids” you take right before you sleep and they “knock you out” but don’t allow you to get the REM and NREM sleep that is so important to your mental, physical and emotional health. Our product is so revolutionary our customers actually take it in the morning for optimal benefits. STUDY FOCUS / NOOTROPIC: You are studying, working a mentally challenging job or just need more study focus; remember that without proper sleep there is a demonstrable impact on your cognitive function. Mental acuity and enhanced focus are your goal when taking a studying supplement. The testimonials we get from our customers are AMAZING. Have you ever heard of a NOOTROPIC that you take in the morning and it gives you mental focus and energy during the day and allows you to sleep better that night? PAIN & INFLAMMATION: Inflammation is a necessary part of the body’s immune response. Chronic inflammation is associated with a number of health issues. An estimated 1 in 4 adults report severe joint pain. Chronic inflammation affects 43 million people in the United States. MyVitalC is a known anti-inflammatory. Management of inflammation is important for all healthy men and women. FEEL THE BENEFITS OF THIS REVOLUTIONARY PRODUCT - BUY WITH CONFIDENCE: We are a US company and the largest manufacturer and distributor of ESS60 on the planet. Buy with confidence from the company who has been selling raw ingredients to research institutions around the world since 1991. The company whose material was used in the original peer-reviewed published a study that reported a 90% increase in lifespan of test subjects. Those same test subjects also died healthier than the control group.
Product Image:
Ingredients:
There are only two ingredients
- High quality organic extra virgin olive oil
- The naturally occurring ESS60 molecule
Product Safety:
This study product contains extra virgin olive oil and ESS60/C60 fullerene, a carbon-based molecule being studied for possible effects on human health. The olive oil itself is a common food oil, but the C60-containing study product is investigational. That means it has not been proven safe or effective for the purpose being studied.
Animal studies of C60 dissolved in olive oil have reported no clear short-term oral toxicity under controlled testing conditions, including a 14-day rat study of C60 in extra virgin olive oil at doses up to 3.8 mg/kg/day. However, human safety data are still limited, especially for long-term use, pregnancy, fertility, cancer risk, drug interactions, and use in people with medical conditions.
Because FDA informed consent rules require participants to be told about reasonably foreseeable risks and, when appropriate, risks that are not yet known, this safety profile should be honest that some risks may be unforeseeable at this stage of development.
Plain-English participant risk statement
Suggested consent language:
The study product contains extra virgin olive oil with ESS60/C60 fullerene. Extra virgin olive oil is commonly consumed as food, but ESS60/C60 in olive oil is investigational. This means it is still being studied and has not been proven safe or effective for the purpose of this study.
Short-term animal studies of C60 in olive oil have not shown clear signs of toxicity under controlled conditions. However, there is limited human safety information, especially with repeated or long-term use. Some risks may not be known yet.
The most likely side effects are mild stomach or digestive symptoms, such as nausea, reflux, loose stools, oily stools, bloating, cramping, or diarrhea. Other possible symptoms include headache, fatigue, rash, itching, or allergic-type reactions. Less common or unknown risks may include effects on the liver, kidneys, blood counts, immune system, or reproductive health.
The study product must be stored and handled exactly as instructed. C60-in-oil products may be sensitive to light. One animal study found that light exposure could create toxic changes in C60-in-oil preparations. For this reason, participants should keep the product in its original container, protect it from light, and not transfer it to another bottle or container.
Expected or reasonably foreseeable risks
Risk area What participants may experience Safety approach
Digestive symptoms Nausea, reflux, oily stools, diarrhea, bloating, abdominal discomfort Take only as directed; report persistent or moderate symptoms
Allergy or sensitivity Rash, itching, swelling, wheezing, throat tightness, hives Stop product and contact study team; urgent care for breathing symptoms
Liver effects Often no symptoms; possible fatigue, nausea, dark urine, yellowing eyes/skin Blood tests for liver markers
Kidney effects Often no symptoms; possible swelling, reduced urination, abnormal labs Blood and urine tests
Blood or immune changes Usually detected by lab tests; possible unusual bruising, infection, fatigue CBC with differential
Light-degraded product risk Unknown; animal evidence suggests possible toxicity if exposed to light Opaque/light-protected packaging; strict storage instructions
Pregnancy/fetal risk Unknown risk to embryo, fetus, or nursing infant Exclude pregnancy/lactation; pregnancy testing where applicable
Drug/supplement interactions Unknown Medication/supplement review; exclude high-risk medication regimens
Unknown or less-characterized risks
Suggested consent language:
Because this is an investigational product, there may be risks that are currently unknown. Researchers do not yet fully know whether repeated use of ESS60/C60 in olive oil could affect long-term health, fertility, pregnancy, cancer risk, immune function, liver function, kidney function, or interactions with medications and supplements.
This is important because prior regulatory reviews of fullerene materials have emphasized uncertainties around impurities, systemic distribution, genotoxicity, phototoxicity, and product-specific differences. A more recent 2025 in vivo micronucleus study of a C60/C70 fullerene mixture in olive oil reported no genotoxic activity under the tested conditions, but that does not eliminate the need to evaluate the exact study product and exposure regimen.
Product Name: MyVitalC Gift Card
Quantity included: 1
Price: $218.00
Product Description: This exclusive $218 MyVitalC Digital Gift Card is awarded to participants who successfully complete the “Sleep & Everyday Headache Management” scientific study. It recognizes your dedication to advancing personal wellness while contributing to meaningful, science-backed research. Designed for use across the MyVitalC store, this digital gift card can be applied toward premium supplements, wellness solutions, and longevity-focused products trusted by thousands worldwide. Why You’ll Love It $218 Value to spend on MyVitalC products Awarded Upon Study Completion as a recognition of your participation Science-Backed Wellness supported by real research Digital Delivery — easy to use and redeem Expires 30 days from being awarded Your participation helps move wellness science forward—and this gift card is our way of saying thank you. Invest in your health. Live beyond the norms.
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 is a table identifying the kinds of people who should avoid being part of this trial:
| Category of Individual | Contraindications | Reason |
|---|---|---|
| Individuals with Allergies | History of allergic reactions to olive oil or related products | Risk of allergic skin reactions such as rashes or hives |
| Individuals with GI Issues | History of severe gastrointestinal problems | Potential for mild nausea or digestive discomfort, particularly on an empty stomach |
| Individuals with Chronic Diseases | Existing chronic health conditions that could be exacerbated | Low likelihood of exacerbation of chronic disease |
| Individuals who are Pregnant or Nursing | Pregnancy or breastfeeding | Limited research and unknown long-term effects on maternal and fetal health |
| Individuals with Severe Headaches | History of severe or chronic headaches | Initial use may trigger mild headaches |
| Individuals Prone to Mood Disorders | History of mood disorders | Potential for mood changes and sleep disturbances |
| Individuals with Dizziness or Fatigue Issues | Prone to dizziness or fatigue | Early stages of treatment may induce feelings of fatigue or dizziness |
| Individuals with Cancer Concerns | High concern for cancer risk | Theoretical very low likelihood of cancer incidence |
| Individuals with Legal or Compliance Restrictions | Subject to organizational or legal restrictions on supplement use | Need to ensure compliance with specific organizations or governing bodies' requirements |
| Individuals with Dependency Concerns | Concern about psychological comfort from routine use | Potential for psychological comfort leading to perceived dependence despite no physical dependence evidence |
Study Design & Experience
Take 1 teaspoon (5 mL) of MyVitalC by mouth every morning, with or without food. Log the treatment daily.
Assesments and frequency:- Weekly: Complete the Weekly Headache Check-In and the PROMIS Sleep Disturbance Scale.
- Baseline and Follow-Up: Complete the PROMIS Pain Interference Scale.
The study titled "MyVitalC: Sleep & Everyday Headache Management" is designed to assess the potential benefits of MyVitalC ESS60 in Olive Oil on enhancing sleep quality and managing everyday headaches over a six-week period. This single-arm observational trial employs a "Signal Phase" approach, where participants serve as their own control. During the initial four weeks, participants establish a baseline by not taking the supplement, allowing for the collection of data on their normal sleep patterns and headache occurrences. Afterward, they begin a daily regimen of MyVitalC, which aims to improve sleep quality and reduce both the frequency and severity of headaches. Participants have the option to document and share their experiences on social media, although this is not mandatory.
The study experience emphasizes the importance of accurate data collection and participant engagement. Initially, participants go through a four-week baseline period without the intervention to capture their usual sleep and headache data, which is crucial for creating a "digital twin." This digital twin will serve as a personalized projection of what might have occurred in the absence of MyVitalC, providing a comparative framework to evaluate the intervention's effects. Participants are tasked with completing regular sleep surveys and headache check-ins, and they are encouraged to be honest and consistent in their responses. Missing data can compromise the study's findings, so adherence to the protocol is vital for obtaining a clear and interpretable outcome.
If the trial indicates a positive signal, meaning there is evidence suggesting MyVitalC effectively enhances sleep quality and reduces headache symptoms, further studies with more robust designs will be considered. These could include randomized controlled trials to validate and expand upon the initial findings. The "Signal Phase" study is expected to yield preliminary safety data, which is currently limited, thereby informing future research endeavors. Participants are advised to contact Efforia for support if they encounter any issues, ensuring that safety remains a priority throughout the study. For comprehensive details on the study protocol, the "Minimal Risk Umbrella protocol" provides an in-depth resource.
Statistical Analysis Plan
However, also in this study, we are going to try a digital twin analysis approach using the extended baseline. In clinical research, a digital twin is a detailed virtual model of an individual patient or biological process that uses real clinical and health data to simulate how that patient might respond to treatments, helping predict outcomes and optimize study design. In this study, the digital twin will serve as a synthetic control or counterfactual in trials, potentially reducing the number of actual participants needed and accelerating drug development.
Limitations & Justification
In conducting this single-arm observational trial under the Minimal Risk Citizen Science Umbrella Protocol, we acknowledge the inherent limitations, particularly the absence of a control group, which can introduce bias and affect the reliability of our findings. However, given the study's objective to provide personalized insights rather than generalized conclusions, participants serve as their own control through a structured baseline comparison. This method allows us to directly assess individual changes in sleep disturbances and headache frequency/severity, despite the lack of a separate control group. To further mitigate bias, an expectations questionnaire is employed to quantify any potential influence of participant expectations on the outcomes, ensuring a clearer interpretation of the results.
Recognizing the potential for bias in single-arm trials, we have meticulously designed our sample size and statistical methodology to enhance the study's robustness. Stratification by participant demographics will be considered, which can help address variability and improve the precision of our data analysis. This approach not only strengthens the validity of our findings but also underscores our commitment to tailoring clinical research to the individual, a key goal of Efforia and the Minimal Risk Umbrella Protocol. By supporting research questions that may otherwise be overlooked, we aim to democratize clinical research, offering a platform for exploring the nuanced effects of interventions like MyVitalC on personal health metrics.
Finally, this study is conceptualized as a signal detection trial, with the primary aim of identifying potential benefits of MyVitalC on sleep quality and headache management. Should our findings indicate a positive signal, they will serve as a foundation for more comprehensive, controlled studies to validate and expand upon the initial insights gained here. This progressive research model ensures that any potential benefits identified are rigorously tested, aligning with our objective to empower participants with evidence-based decisions about their wellness while contributing to the broader scientific understanding of MyVitalC's efficacy. For more information, individuals are encouraged to refer to the Minimal Risk Umbrella Protocol.
Human Subjects Ethics
Suitability Under Minimal Risk Umbrella Protocol
The protocol titled "MyVitalC: Sleep & Everyday Headache Management" appears to be suitable for inclusion under the minimal risk umbrella protocol. The study focuses on analyzing interventions that are "Generally Recognized as Safe" (GRAS) and falls within the health and wellness domain by exploring non-regulated dietary supplements. The interventions do not require a physician's diagnosis or prescription, and the study's aim is to enhance general health, productivity, and wellness within normal ranges. Moreover, the study does not involve more than minimal risk, as it examines legal, easily accessible interventions without a prescription or physician diagnosis in the research jurisdiction. Additionally, it does not include vulnerable populations, as defined by the Common Rule, and does not involve elements illegal in the defined jurisdiction.
Furthermore, the protocol meets the other criteria for eligibility under the umbrella protocol. The study is longitudinal, lasting several days, and involves two or fewer blood draws or other bodily fluid specimen collections, adhering to the protocol's stipulation for the US. It avoids any form of blinding, deception, or comparative study design and does not require specific eligibility criteria beyond the availability of the intervention or measurement. There are no elements of intentional bias, unnecessary sexual content, or violence, and the study has a defined intervention rather than merely collecting data. Therefore, the protocol aligns well with the guidelines and is suitable for inclusion under the minimal risk umbrella protocol.
Suitability for Pay to Participate Model
The MyVitalC: Sleep & Everyday Headache Management study involves participants paying for MyVitalC ESS60 in Olive Oil Extra Virgin Organic, a product that is legally available on the open market in the United States. This product is generally sought after by consumers interested in enhancing sleep quality and managing everyday headaches, indicating a willingness to pay for its purported benefits. The price of $218 for 120ml of MyVitalC ESS60 in Olive Oil is consistent with or competitive compared to similar products in the health and wellness market, suggesting that the cost is not disproportionately high. Furthermore, the study provides additional value by offering participants a structured protocol to evaluate the effects of the product on their well-being, accompanied by the opportunity to share personal experiences and data for broader scientific and community insight. This enhances the perceived value beyond just purchasing information or convenience.
Considering the typical target market for these products, many consumers likely have the financial capacity to cover the costs without experiencing serious financial hardship. The study is designed to appeal to health-conscious individuals who prioritize personal wellness and are accustomed to investing in health-related products. Additionally, the voluntary nature of the study, coupled with the option to share experiences on social media, empowers participants to make informed decisions without undue pressure. This mitigates the risk of significant buyer's remorse, as participants are aware of the product's market availability and its financial requirements before committing to the study. By ensuring transparency and maintaining ethical standards, the study respects participant autonomy and supports informed, autonomous decision-making.
Human Subjects Protection Questionnaire
Beneficence
Is there a description, unambiguous research question, and purpose?
Yes, the study has a clear research question and purpose, focused on evaluating the specific product or service that participants have purchased. The study aims to generate valuable insights into the efficacy and safety of the product, providing both generalizable results and specific insights for the participants.Is the study built on what is known already?
Yes, the study builds upon existing knowledge by leveraging current understanding and previous research on the product or service being evaluated. This approach ensures that the research is grounded in established science while seeking to contribute new insights.Will the study provide meaningful answers to the research question?
Yes, the study is designed to provide meaningful answers that are both generalizable and pertinent to the individual participants. By engaging those who have already purchased the product, the research is directly relevant to their experiences and needs.Will the study provide valid answers to the research question?
Yes, the study is structured to provide valid answers by employing robust methodologies and leveraging the decentralized nature of Efforia's platform. This ensures the collection of reliable data that can address the research question with integrity.
Non-maleficence
Are participants recruited with justifiable inclusion and exclusion criteria?
Yes, any individual who has already purchased the product is eligible to participate, emphasizing participant responsibility for identifying if the protocol is suitable for them. Clear risks and considerations are provided in the informed consent to guide participants' decisions.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 experience and infrastructure, including the extensive support of the Efforia platform. The Principal Investigator, Matthew Amsden, brings significant expertise in decentralized trial innovation and management, ensuring the study is conducted effectively.Is there a fair balance of benefits and harms (risks) for all with an interest in the study?
Yes, the study's approach offers added value to participants at no additional cost, and the minimal risk nature of the interventions ensures a favorable balance of benefits and risks.Will participants receive appropriate care both during and after the study?
Yes, participants are advised to seek their own medical care in the case of an adverse event, with the study providing additional monitoring and support beyond what is typically available for such interventions.Is personal data handled appropriately (confidentiality)?
Yes, personal data is managed according to the protocols outlined in the Minimal Risk Umbrella protocol, ensuring confidentiality and appropriate handling.
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, ensuring participants can make an informed decision about their involvement.Has the research incorporated patient and participant views?
Yes, Efforia's platform inherently incorporates participant views, and this study specifically includes feedback mechanisms to gather participant input and enhance the research process.
Justice
Are there fair payments for participation and financial recompense in case of harm?
Yes, while participants pay to participate, the study provides valuable product insights and health tracking. Participants are aware that medical care costs are their responsibility, but incidents are reported to Efforia for further action.Do participants have access to an independent complaints procedure (or advocate)?
Yes, participants can contact Efforia's support for concerns, and independent ethics review board contacts are included in the informed consent for additional support.Will the project be registered and results reported in the public domain?
Yes, Efforia commits to transparency, making results available to participants and contributing generalizable findings to the public domain.