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Independent Review Board Certified Study on Human Subjects

Clinical Study on Blushield Efficacy

As part of the study Blushield demonstrated statistically significant data regarding the voltage-gated calcium channel gene expression, as well as improvements in composite memory, cognitive flexibility, executive function, and processing speed. Heart rate variability, blood glucose, NK cells and deep sleep.

For the updated Published Peer Reviewed Study published in October 2024 Click here

Background and Interpretation

In September 2020 Blushield USA was contacted by Tom Blue, the owner of a research company and Executive Director of the American Academy of Private Physicians. He had recently discovered Blushield EMF protection devices, and noticed significant positive results from using the devices on himself, his wife and their son. The family regularly track various health markers using the Oura Ring device. They saw significant results in their sleep quality and heart rate variability.

He proposed studying the health effects of Blushield Devices on humans, on a larger scale than we have done previously. Tom and his partners, Helen Messier, MD, PhD and DeAunne Denmark, MD, PhD could work with independent labs to conduct the study. They also had clear guidelines about the structure and focus of the study, the health markers to track, and how to recruit participants from their doctors network.

Due to Covid there were delays and in March of 2022, test kits were made and sent to all the participants, as well as a Premium Ultra U2 home plug-in, a  Plugin / Premium Portable for the participants who worked away from home or traveled often. The goal was to ensure they were within the Blushield frequency field range as often as possible during the 12-week study duration.

This pilot study focus was to assess the feasibility and preliminary signs of efficacy of the devices on a small sample group within a fairly short time frame. This would then help determine if a full-scale research project would be worth planning for in the future.

About the Participants

All 25 participants worked in the health and wellness industry, some included general practitioners and physical therapists. At the beginning of the study, all participants were self-reported to be in relatively good health.

This was a single-arm study, in this case referring to a “before and after” type study, where all participants were tested before using Blushield, then again during and after 12 weeks in the influence of the Blushield device.

All participants reported 100% compliance with the Blushield device usage for the duration of the study, this meant they remained within the Blushield field. This  increases the validity of the results and the feasibility (ease and practicality) of using the devices. During the 12-week study, No adverse affects were reported.

Health Markers

Using Several Methods, an array of health markers were tested. These included laboratory panels assessing overall physiological health; a panel of blood markers related to inflammation, oxidative stress, DNA damage and cellular senescence; a genome-wide assessment of DNA methylation (including the voltage-gated calcium channel sites); a full neurocognitive assessment every 4 weeks of the study; the use of the wearable health tracker (the Oura Ring) to analyze changes in sleep quality, heart rate variability, and related health markers; and self-reported health questionnaires.

Currently Blushield USA cannot publish the actual manuscript of the study because it is under review by a prominent medical journal. They will post a link to the full study manuscript on their site once the journal has reviewed it.

Analysing and interpreting the results

Currently Blushield USA and in turn Blushield SA is allowed to share an interpretation of the results. Brandon and his team have written the below  – thank you all. Once you are able to read through the paper itself, you may be wondering what the terms mean, and want more explanation of the significance of each finding.

The study paper was written by Christopher D’Adamo, PhD, an epidemiologist who has served as Principal Investigator on a wide variety of observational and interventional studies of nutrition and other healthy lifestyle modalities, his findings have been published in several well-known peer-reviewed scientific and medical journals, and publicized through several popular media outlets.

The study co-authors include the researchers involved in compiling and interpreting the data: researchers from TruDiagnostic (the epigenetic data analysis company that provided the genome-wide DNA methylation assessment), doctors Helen Messier and DeAunne Denmark, who organized the study, and Tom Blue, who initiated the study.

In the study paper, it states: “Preliminary data from in vitro and agricultural animal studies suggest changes in biomarkers of health and functional status may be detectable after a period of continuous BluShield device usage.”

This refers to the prior Blushield studies from several years ago, the grassroots-style testing which initially found positive results on animals and humans, including live blood cell analysis, human urine analysis, as well as health improvements in chickens and cows.

Brandon and his team knew it was time for a more thorough study on a greater number of human health markers, using a newer, more powerful Blushield device, and are so excited that the study has been completed and the results affirm the testimonial feedback.

What improvements were found in this independent review board certified pilot study?

Cognitive function improvements

The CNS Vital Signs assessment serves as a comprehensive tool for evaluating neurocognitive function, offering valuable insights into memory, executive function, and processing speed. In our study, participants underwent this assessment prior to the introduction of the Blushield device and subsequently every four weeks throughout the 12-week duration, totaling four assessments. Encouragingly, our findings revealed statistically significant improvements in composite memory, cognitive flexibility, executive function, and processing speed following the introduction of the Blushield device. While some areas such as visual memory and simple and complex attention showed no significant changes, the noteworthy enhancements observed in other domains underscore the potential benefits of Blushield technology.

Moreover, this investigation aligns with existing literature associating electromagnetic field exposure with cognitive impairments. A notable mechanism proposed in prior research, as touched on in a Blushield USA article Memory, Learning & Attention Impairment From EMF Exposure, involves the overactivation of voltage-gated calcium channels. This mechanism underscores the importance of exploring innovative solutions like the Blushield device to mitigate potential cognitive risks associated with electromagnetic field exposure.

Voltage-gated calcium channel improvements

The positive outcomes observed in the study regarding cognitive function may indeed be linked to the activity of voltage-gated calcium channels (VGCCs), as suggested in the research paper. This hypothesis warrants further investigation. The study identified a key VGCC gene (CACNA1G) that exhibited hypermethylation in the genome-wide DNA methylation assessment. Hypermethylation typically indicates a reduction in gene expression, essentially quieting the overactive VGCCs that are continuously stimulated by modern levels of electromagnetic fields (EMFs).

The differential methylation analysis revealed 204 CpG sites, with 94% of them showing hypermethylation. Notably, many of these sites were associated with ATP-sensitive potassium channels, which are known to be influenced by EMFs. Apart from the prominently hypermethylated VGCC gene, four other VGCC-related genes were also found to be close to the threshold of significance.

CpG, short for Cytosine-phosphate-Guanine, represents the most common methylation pathway in DNA. DNA methylation plays a crucial role in epigenetics, the study of gene activation or silencing in response to environmental factors. This dynamic process helps explain why individuals with similar genetic backgrounds can experience different health outcomes due to various environmental influences throughout their lives.

Furthermore, DNA methylation serves to silence intragenomic parasites, such as transposons and endogenous retroviruses, which constitute a significant portion of the human genome. Optimal methylation keeps these parasites dormant. However, disruptions in methylation due to factors like toxic heavy metals and EMFs can activate these retroviruses, leading to adverse effects on overall health.

See article here from Blushield USA:
https://www.blushield-us.com/blogs/education/emfs-retroviruses-and-chronic-illness

Meaningful improvements in sleep quality and heart rate variability

All participants in the study were equipped with an Oura Ring device for the entire duration, spanning from the preliminary phase before Blushield introduction to the 12-week period of Blushield utilization. This wearable health tracker continually monitors a range of pertinent health indicators, facilitating real-time monitoring of lifestyle effects.

The device meticulously tracks the entirety of the sleep cycle, offering comprehensive insights into the duration of deep sleep, REM sleep, light sleep, and periods of wakefulness. Additionally, it captures heart rate variability (HRV) continuously, a pivotal metric associated with vigor, resilience, and adaptability. HRV reflects the heart’s capacity to promptly adjust to environmental demands by modulating its rhythm accordingly. The seamless modulation of heart rate in response to situational demands is closely intertwined with overall health and vitality.

 

You can learn more about the complex nuances of heart rate variability in this article Blushield USA wrote:

https://www.blushield-us.com/blogs/education/heart-rate-variability-hrv-as-an-advanced-biomarker-is-affected-by-emfs

The study revealed statistically significant improvements in heart rate variability, average and lowest resting heart rate, body temperature, and duration of deep sleep.Average deep sleep time increased by 9 minutes, from 90 minutes before to 99 minutes after. There was also an increased average awake time (by 5 minutes), which in some instances wouldn’t be desirable. It’s conceivable that this could be attributed to the assumption that with an additional 9 minutes of deep sleep per night, individuals may require slightly less overall sleep duration for adequate rest

Reduction in blood glucose

EMF exposure has been shown to be linked to elevated blood glucose, and in some cases, even prediabetes and diabetes. This is thought to be related to the voltage-gated calcium channels, which our previous article on blood glucose and insulin elaborates on:

Exposure to electromagnetic fields (EMFs) has been associated with higher blood glucose levels, and in some instances, it may even contribute to the development of prediabetes and diabetes. This correlation is believed to be connected to the activity of voltage-gated calcium channels, as discussed in an earlier article by Blushield USA focusing on blood glucose and insulin regulation see here: https://www.blushield-us.com/blogs/education/blood-glucose-and-insulin-negatively-affected-by-emfs

Interestingly, all participants initially had blood glucose levels within the healthy range at the start of the study. Despite this, we observed a statistically significant decrease in blood glucose levels throughout the study period. It’s worth noting that the impact could have been more pronounced if individuals with diabetes or prediabetes had also participated in the study, highlighting a potential avenue for future research.

Furthermore, glucose and insulin regulation are strongly influenced by ATP-sensitive potassium channels. Therefore, the observed positive effects on blood glucose levels might be associated with the hypermethylation of the ATP-sensitive potassium channel complex documented in our study, in addition to the activity of voltage-gated calcium channels.

 

Changes in immune markers & self-reported health improvements

The study also found an increase in monocytes and a decrease in natural killer cells (NK cells), both within a healthy range. Monocytes remain in their basic form in the bloodstream and organs when there are no active threats, but as soon as a threat is perceived, they differentiate into either macrophages or dendritic cells. However, NK cells remain in their original form while fighting infection. When monocytes differentiate into dendritic cells, this then alerts other cells (including NK cells) of the presence of an imminent threat.

There is a hypothesis that electromagnetic field exposure triggers the immune system, as our bodies perceive the foreign frequency patterns as invaders it needs to attack and defeat. Since there is nothing physically present to attack and destroy, this can result in a chronically elevated immune response, which will eventually deplete the immune system of its power and steal vital resources from other essential processes in the body. Our long-held theory, based on the results of our previous studies, is that being in the influence of a Blushield gives the body a healthy field to preferentially resonate with, calming and subduing the futile immune response against the perceived invasion of the harmful fields.

 

An increase in circulating monocytes could indicate that they are now “ready and waiting” in their natural form, and not currently in the process of fighting infection by differentiating into other forms. A decrease in natural killer cells could signify the immune system calming down from a previously chronically overactive state, as the monocytes are not actively signaling a threat that would tell the NK cells to get to work. More targeted and larger scale studies will be needed to confirm this hypothesis

Also, each participant was given a self-reported health questionnaire at various times throughout the study period, and there was a statistically significant improvement in the participants’ subjective experience of overall health and well-being.

 

The study also observed a rise in monocytes and a decline in natural killer (NK) cells, all remaining within healthy levels. Monocytes typically stay in their basic form in the bloodstream and organs until they sense a threat, upon which they transform into either macrophages or dendritic cells. Meanwhile, NK cells remain unchanged as they combat infections. When monocytes become dendritic cells, they signal other cells, including NK cells, of a looming threat.

There’s a notion that exposure to electromagnetic fields stimulates the immune system, perceiving the unfamiliar frequency patterns as invaders to combat. However, without a tangible threat, this can lead to a sustained immune response, eventually depleting its strength and diverting resources from essential bodily functions. Building on previous findings, our hypothesis suggests that being within the range of a Blushield Device creates a healthy field for the body to resonate with, soothing the immune response against perceived harmful fields.

The uptick in circulating monocytes may indicate readiness in their natural state, no longer actively combating infections by transforming into other cell types. Conversely, the decrease in NK cells suggests a calming of the immune system from its previously hyperactive state, as monocytes aren’t signaling an imminent threat to activate NK cells. Confirming this hypothesis will necessitate more extensive and targeted investigations.

Furthermore, participants completed self-reported health questionnaires at intervals during the study, revealing a statistically significant enhancement in their overall health and well-being perception.

Understanding P-values and confounding factors

When you have a chance to fully assess the actual study paper, grasping the concept of P-values is vital in the wellness field. These values play a crucial role in clinical studies, indicating whether a finding is statistically significant or merely a chance occurrence.

P-values, short for probability values, are closely tied to the “null hypothesis.” This hypothesis suggests that in any scientific inquiry, there’s a possibility that the treatment or intervention being examined has no discernible impact on the participants. Consequently, any observed outcomes could be due to random chance alone. In essence, achieving a low p-value is desirable for establishing the significance of positive results. The lower the p-value, the less likely the observed outcomes are attributable to chance. However, it’s essential to note that even with an extremely low p-value, there remains a minute chance of randomness, as this value can never reach absolute zero.

In clinical research, the significance threshold for the p-value is typically set at a predetermined level, often denoted as p<0.05. Here, 0.05 represents 5%, meaning that a p-value below this threshold indicates a less than 5% probability that the observed results occurred randomly. Results surpassing this threshold are deemed statistically significant.

For instance, if a study reports a p-value of p=0.01, it suggests a mere 1% chance of randomness in the results, indicating a strong likelihood that the intervention (such as the Blushield device in our case) directly influenced the outcomes, as observed in our study on resting heart rate. Some findings may exhibit even lower p-values, such as p=0.0007 for cognitive flexibility, indicating an exceedingly slim probability of randomness.

Furthermore, the study paper may delve into confounding factors, which are unmanageable variables inherent in the study design that could impact the results, particularly in studies lacking a control group. These factors encompass external influences encountered in daily life, like fluctuations in physical activity or dietary habits due to seasonal changes. Additionally, the homogeneity of the test subjects in terms of health status, education level, and race should be considered. Notably, our study comprised predominantly healthy individuals; however, including more participants with chronic illnesses could have provided further insights into potential improvements from baseline.

Accuracy score of our methylation results was close to perfect 

Understanding changes in DNA at the molecular level can be quite intricate, especially for those unfamiliar with the process. Researchers involved in these measurements undergo specialized training to ensure accuracy. They also develop models that consider various factors like age, gender, immune markers, and numerous other variables to produce precise results.

The aim is to establish a model that demonstrates a clear cause-and-effect relationship, where factors relevant to the study (known as covariates) are seamlessly integrated. In our case, this would mean accurately measuring how Blushield usage influences methylation of CpG sites while accounting for covariates’ influence.

While achieving a perfect fit is impossible, there are methods to evaluate the model’s accuracy. Ideally, a score of “1” indicates a perfect fit, implying minimal interference from covariates. Scores below 1 suggest excessive covariates, diminishing result significance, while scores above 1 indicate inadequate covariates, potentially inflating result significance.

In our study, our model’s score was 1.05, indicating near-perfect alignment. This is considered quite commendable, as such precision is challenging to attain. Consequently, the methylation results observed on the CpG sites, including those associated with voltage-gated calcium channel genes, were highly accurate and close to pure.

Final thoughts

The completion of this study has been a lengthy journey, requiring immense dedication and perseverance from the Blushield USA team. Daily at Blushield offices around the world we hear numerous firsthand accounts shared by our customers, both through direct communication and voluntary reviews on our website of the impact of Blushield Technology. Many have described the devices as transformative and life-changing.

These candid testimonials play a crucial role in guiding prospective customers, offering insights into the real-life impact of the technology. With the culmination of our first independent, review board-certified clinical study, individuals can now access even more comprehensive information about the potential benefits our products may offer in enhancing their wellbeing.

While our pilot study may have been modest in scale, it marks a significant step forward for us as the first EMF protection company to explore the impact of our devices on voltage-gated calcium channel genes, yielding promising results. Moving forward, we’re committed to conducting more extensive studies to further validate these findings.

The study’s findings suggest that Blushield devices are not only feasible and safe but also linked to notable enhancements in various aspects of wellbeing, including cognitive function, sleep quality, heart rate variability, gene normalization, blood glucose levels, immune response, and overall self-reported health among individuals with relatively good health. Additionally, the study underscores the potential of these devices as part of a comprehensive strategy to reduce RF exposure, aligning with our recommendation for their use.

If you know someone worried about the impacts of EMFs on their health and searching for trustworthy solutions backed by research, please pass along this valuable information.

 

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