In the News
VitaK-CAC Study Results Presented at Linus Pauling Institute Conference
Biomarker could detect Alzheimer's years before symptoms appear, study finds
Frequent Cannabis Users Show No Driving Impairment After Two-Day Break
Thorne Shines Spotlight On Creatine With New Campaign Featuring Grammy Award Winning Musical Artist Ciara
Restorative Formulations Honored with 2025 NDNR Physicians Choice Award in Supplements & Nutraceuticals
New Study from Lindus Health Finds Nearly Half of Consumers Will Abandon Health Products Lacking Clear Scientific Evidence
New Study Boosts Trial Precision in Measuring Pain, Mood, and Fatigue
VitaK-CAC Study Results Presented at Linus Pauling Institute Conference
Professor Leon Schurgers, PhD, internationally recognized vitamin K expert, Chair of the Department of Biochemistry at CARIM, Maastricht University (NL), presented compelling initial results from the VitaK-CAC Trial at the prestigious Linus Pauling Institute (LPI) “Diet and Optimum Health Conference.” The event was held in Corvali, OR, in September and was sponsored by Gnosis by Lesaffre, maker of MenaQ7® vitamin K2, the source material for the trial.
Coronary Artery Calcification (CAC) is a significant risk factor for cardiovascular disease, serving as an early marker of atherosclerosis. CAC occurs when calcium deposits accumulate in the artery walls, hardening them and increasing the risk of heart attacks, heart failure, and stroke.
In his presentation, “The Role of Vitamin K in Aging: From Development to Senescence,” Prof. Schurgers expounded on the evidence of vitamin K2 as MK-7 supplementation in slowing the progression of CAC through its ability to carboxylate Matrix Gla Protein (MGP), a protein responsible for protecting against vascular calcium deposition.
Novel Cardiovascular Support
His presentation covered a new randomized, double-blind, placebo-controlled clinical trial that sought to determine the protective effect of 2 years of supplementation with MK-7 (as MenaQ7®) on slowing the progression of CAC in men and women. MK-7 levels rose significantly in the supplement group but not in the placebo. And while inactive Matrix Gla Protein (dp-ucMGP) levels rose in both groups, the MK-7 group had significantly less. Further, while progression of calcification continued in both groups, MK-7 was able to significantly slow the rate of progression.1
The new study was initiated based on the 2015 breakthrough 3-year study with MK-7 demonstrating improvements in arterial flexibility through reduced calcification in healthy post-menopausal women. 2
Prof. Schurgers, who chairs the Gnosis Vitamin K2 Scientific Advisory Committee, commented: “This trial breaks new ground by showing, for the ?rst time, that a vitamin can slow CAC progression, help postpone the development of coronary calcium buildup in individuals with coronary artery disease. This is a major step forward in translating MK-7 science into clinical cardiology. MenaQ7® continues to prove its exceptional value in proactive cardiovascular care.”
Significance of Presenting at LPI
The Linus Pauling Institute (LPI) is one of the most credible, visible research groups in the US. Its mission is to promote optimal health through cutting-edge research and trusted public outreach.
“This is the first study to achieve statistical significance in its primary outcomes, a result the clinical community has eagerly awaited for a long time,” stated Prof Schurgers. “What better opportunity to share the preliminary findings than at such a revered event?”
Gnosis has long recognized the value of working with non-commercial organizations around the world, such as the Council for Responsible Nutrition and ILSI Europe, as well as the weight it carries when these organizations acknowledge the impact vitamin K can have on improved global health.
“Prof. Schurgers’ presentation is the latest in Gnosis’s continually expanding scientific educational outreach program, and it certainly won’t be the last,” added Lacey Hall, Gnosis Director of Medical Affairs. “MenaQ7 has a robust and growing portfolio of evidence showing that it is one of the most powerfully authentic ‘anti-aging’ supplements available for healthy consumers as well as for populations requiring cardiovascular support.”
Photo caption: Prof. Leon Schurgers with LPI Director Emily Wong
References:
1 Vossen et al. “Menaquinone-7 Slows Down Progression of Coronary Artery Calcification: A Randomized, Placebo-Controlled Trial” J Hypertension 2025 May 43(Suppl 1):p e18.
2 Knapen et al. “Menaquinone-7 supplementation improves arterial stiffness in healthy postmenopausal women. A double-blind randomized clinical trial.” Thomb Haemost. 2015 May;113(5):1135-44.
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About Gnosis by Lesaffre
Gnosis by Lesaffre harnesses the power of microorganisms and biotransformation processes like fermentation to cultivate nutritional actives, probiotics, and nutritional and functional yeasts that benefit human health and well-being. The team draws on its focused research and application capabilities to collaborate with nutraceutical and pharmaceutical brands to develop game-changing products for their customers.
Gnosis by Lesaffre – Exploring Life to Improve Living. http://www.GnosisByLesaffre.com
About Lesaffre
A key global player in fermentation for more than a century, Lesaffre, with a 3 billion euro turnover, and established on all continents, counts 11,000 employees and more than 90 nationalities. On the strength of this experience and diversity, we work with customers, partners, and researchers to find ever more relevant answers to the needs of food, health, naturalness, and respect for our environment. Thus, every day, we explore and reveal the infinite potential of microorganisms.
To nourish 9 billion people, in a healthy way, in 2050 by making the most of our planet’s resources is a major and unprecedented issue. We believe that fermentation is one of the most promising answers to this challenge.
Lesaffre – Working together to better nourish and protect the planet. http://www.Lesaffre.com
Biomarker could detect Alzheimer's years before symptoms appear, study finds
TSPO, a key biomarker of brain inflammation, could help detect Alzheimer's disease years before memory loss and other symptoms set in – potentially leading to advances in how the disease is diagnosed and treated, according to a study published in Acta Neuropathologica.
"This is the first study to really examine how early this biomarker increases and where it begins rising in the brain," said Tomás R. Guilarte, lead researcher and dean of FIU's Robert Stempel College of Public Health & Social Work. "If we can use this information to help delay Alzheimer's progression by even five years, it can drastically improve patients' lives and reduce disease prevalence."
Guilarte, an internationally established expert on TSPO (or translocator protein 18 kDa) has studied the protein for more than three decades. His work helped establish it as a reliable imaging biomarker used in diagnosing neuroinflammation in various neurodegenerative, neurological and psychiatric disorders.
For this study, Guilarte and his team used advanced imaging software to track TSPO levels in genetically engineered mouse models of familial Alzheimer's and confirmed their findings using human brain tissue donated by members of the world's largest group of individuals with early-onset familial Alzheimer's, located in Antioquia, Colombia.
These families carry the "paisa" mutation, identified by the late Dr. Francisco Lopera, one of the authors of the study, who remained dedicated to finding ways to prevent Alzheimer's disease. For carriers of this mutation, symptoms typically begin in their 30s to 40s; they die in their 50s.
In the mouse model, researchers detected elevated TSPO levels in the subiculum – a critical part of the hippocampus – as early as six weeks of age, roughly equivalent to age 18–20 in humans. Microglia, the brain's main immune cells, specifically those clustered around amyloid plaques, had the highest levels of TSPO. Notably, female mice had higher TSPO levels, mirroring real-world statistics: two-thirds of Alzheimer's patients are women.
The brain tissue samples from the Colombian patients with the paisa mutation showed the same pattern. Even in late-stage Alzheimer's, TSPO remained high in microglia near plaques. These results raise new questions about TSPO's function – whether it contributes to damage or protects the brain – and whether blocking or enhancing it could halt disease progression.
The team is now working with a specially developed Alzheimer's mouse model lacking TSPO to explore these questions further. They're also expanding the study to include sporadic, late-onset Alzheimer's cases, the form that accounts for over 90% of all diagnoses.
"The more we understand these processes," said Daniel Martínez Pérez, first author and Ph.D. candidate in Guilarte's lab, "the closer we get to tailoring treatments that can truly help – before it's too late."
Multimedia assets, including photos for media use, are available here.
For more information about this study, please visit https://go.fiu.edu/alzheimers. -FIU-
About FIU:
Florida International University is a Top 50, preeminent public research university with 55,000 students from all 50 states and more than 140 countries, as well as an alumni network of more than 340,000. Located in the global city of Miami, the university offers more than 200 degree programs at the undergraduate, graduate and professional levels, including medicine and law. FIU faculty are leaders in their fields and include National Academy members, Fulbright Scholars, and MacArthur Genius Fellows. A Carnegie R1 institution, FIU drives impactful research in environmental resilience, health, and technology and innovation. Home to the Wall of Wind and Institute of Environment, FIU stands at the forefront of discovery and innovation. With a focus on student success, economic mobility and community engagement, FIU is redefining what it means to be a public research university.
Frequent Cannabis Users Show No Driving Impairment After Two-Day Break
Scientists from the Center for Medicinal Cannabis Research (CMCR) at the University of California San Diego School of Medicine found that, in the largest such study to date, frequent cannabis users did not display impairments in driving performance after at least 48 hours of abstinence. The new findings have implications for public health as well as the enforcement of laws related to cannabis and driving.
Approximately three-quarters of Americans live in a state where cannabis is legally available, and about 15% of Americans currently use cannabis. As cannabis usage becomes more widespread, understanding its effects on daily activities like driving is crucial to maintaining public safety and appropriate legislation around cannabis use.
While acute cannabis intoxication can impair driving, it can be challenging to enforce cannabis and driving laws because, unlike alcohol, there is no biological test (e.g., blood concentrations) that directly relates to cannabis intoxication. Tetrahydrocannabinol (THC), the psychoactive compound in cannabis, can be detected in blood for several days to weeks after use, and in urine for weeks or even months.
One unanswered question around cannabis and driving is whether frequent cannabis users, who may or may not still have THC detectable in their blood, experience reduced driving abilities when not actively high. To answer this question, researchers analyzed data from two studies. The first, a randomized clinical trial, assessed driving performance in a sample of 191 cannabis users, all of whom had abstained for at least 48 hours. The second study compared a subset of the most frequent users from the first study with a smaller comparison group of people who don’t use cannabis. A driving simulator was used to assess driving performance and potential impairment.
The researchers found no indications of reduced driving ability in cannabis users who had abstained for at least two days. First-author Kyle Mastropietro, a graduate student in the San Diego State University/UC San Diego Joint Doctoral Program in Clinical Psychology, commented, “We did not find any relationship between driving performance, and cannabis use history or time of abstinence, nor blood THC concentrations. Of note, the most intensive users from the group, who mostly used cannabis daily and smoked an average of four joints per day, did no worse during this period of abstinence than a healthy, non-using comparison group.”
Thomas Marcotte, Ph.D., professor of psychiatry at UC San Diego School of Medicine and the study’s senior author, added, “The findings add to the growing body of evidence that relying on blood THC concentrations in regular cannabis users as possible indicators of impairment is not justified, given that THC may be detectable many days (or longer) after use.” Marcotte, who is also the co-director of the CMCR, added that “the findings reinforce the challenges in relating findings from cognitive testing in very frequent users who are abstinent to how they might function during real-world, overlearned behaviors like driving.”
The authors note that this study was done in a controlled lab environment, did not address all possible driving scenarios, and the nonuser comparison group was small. That said, the findings do provide new insights into the potential risks and consequences of chronic cannabis use.
The study was published in Psychopharmacology on September 6, 2025. It was funded, in part, by the State of California award to the CMCR via Assembly Bill 266 (Bonta/Cooley/Jones-Sawyer/Lackey: Agreement #907). The authors declare no conflicts of interest.
Thorne Shines Spotlight On Creatine With New Campaign Featuring Grammy Award Winning Musical Artist Ciara
Thorne, the leader in science-backed health and wellness solutions for personal performance, unveiled today its Creatine Campaign spotlighting the supplement’s wide-ranging benefits including performance, endurance and cognition. Featuring musical icon, entrepreneur philanthropist and mother, Ciara, the campaign challenges the long-held notion that creatine is just for bodybuilders and athletes, redefining it as a tool for those seeking the wide range of benefits creatine offers. With her newly released album CiCi and busy schedule on and off the stage, the spot highlights the impressive mental and physical excellence that goes into Ciara’s everyday performance.
“I know it all looks easy, but being and staying at peak performance is a lot more than just hours of rehearsal in the studio,” said Ciara. “My focus and top priority is always finding ways to better myself holistically – which starts with what goes into my body each and every day. I’ve been a long-time fan of Thorne and love that I can trust their science-backed supplements – notably, Creatine – to support not just my overall physical well-being, but to help me stay sharp and maintain endurance.”
Creatine is a naturally produced amino acid found primarily in the muscles and in the brain and the most extensively studied supplement on the market. Thorne’s Creatine features a micronized creatine monohydrate for superior dissolvability and absorption. It is also NSF Certified for Sport®, meaning each batch of Thorne’s Creatine is tested for compliance with label claims to ensure the absence of nearly 300 substances banned by major athletic organizations.
“Creatine isn’t new by any means, but it does offer so much more than the main buzzwords we so often hear when it comes to the product,” said Mary Beech, Chief Growth Officer at Thorne. “The campaign taps further into Thorne’s broader Thorne For platform and shines light on the fact that creatine is for everyone with a broad range of science-backed benefits across performance, endurance and cognitive focus.”
The Creatine Campaign, created by international creative studio, Frosty and directed by Grammy Award winner Jack Begert, will launch with a comprehensive set of video and still assets to be used across digital out-of-home (DOOH), connected TV, display, paid search, YouTube, social media and influencer marketing. The campaign will run September 8 – November 1 nationwide with DOOH active in 4 markets including Atlanta, Los Angeles, Miami and New York.
Thorne’s Creatine product suite includes:
Creatine – 180 servings, MSRP $82
Creatine – 90 servings, MSRP $43
Creatine – 30 servings, MSRP $35
Coming Soon – Flavored Creatine (Strawberry and Pineapple Orange) – 60 servings, MSRP $48
Thorne will continue to enhance its creatine offerings, launching additional creatine products over the next several months. For more information about Thorne’s Creatine and its premium suite of product solutions, Ciara’s favorite products, and the campaign, visit https://www.thorne.com/featured/creatine.
About Thorne:
Thorne is the leader in science-backed health and wellness solutions committed to helping individuals live healthier longer. As the top recommended clinical brand by healthcare practitioners, Thorne offers a comprehensive range of products including nutritional supplements and health tests designed to meet the unique needs of individuals at every stage of life. Founded in 1984, Thorne products are formulated with the highest-quality ingredients, supported by clinical research, and rigorously tested to ensure purity, potency, and efficacy. Thorne is trusted by 47,000+ health-care professionals, thousands of professional athletes, more than 100 professional sports teams, multiple U.S. National Teams, and more than seven million consumers. For more information, visit Thorne.com.
Restorative Formulations Honored with 2025 NDNR Physicians Choice Award in Supplements & Nutraceuticals
Restorative Formulations has been named the 2025 Physicians Choice Award winner in the Supplements & Nutraceuticals category at Naturopathic Doctor News & Review (NDNR)’s 20th Anniversary Physicians Choice Summit & Expo, produced by NDNR, the award-winning publisher of Applied Naturopathic Medicine.
“We are so honored to win this award! We have had a loyal naturopathic base for over 20 years because of our clinically therapeutic formulas, created by our founder, Dr. Michael Friedman.” said Jen Palmer, ND, VP Restorative Formulations.
“This recognition shows how Restorative Formulations has earned the trust of practitioners by delivering consistent, effective results,” said Kareem Kandil, MD, ND, Medical Director at NDNR.
About Restorative Formulations
Founded in 2000, Restorative Formulations is a physician-owned nutraceutical company based in Vermont. It provides high-potency, organic formulations to support hormone balance, cardiovascular health, and immune function, trusted by clinicians worldwide.
Celebrating 20 years of advancing integrative healthcare through case reports and education.
New Study from Lindus Health Finds Nearly Half of Consumers Will Abandon Health Products Lacking Clear Scientific Evidence
Transparency about side effects and long-term safety top the list of factors Americans consider when buying health products, with price also remaining a key consideration. This gap between what consumers want and the information provided by physicians and manufacturers was highlighted in a new survey by Lindus Health.
The survey, conducted by Lindus Health, the anti-CRO running radically faster, more reliable clinical trials, asked 175 participants about their health-based purchasing behaviors. It explored how closely people follow the advice of their primary care physicians and what information they feel is missing when evaluating health products. The findings show less than 14% of respondents follow their physician's recommendations on health products, and in open-ended responses, more than half of participants said they wished information on side effects, product usage, and product safety were easier to find.
When asked what clinical evidence would most influence their purchase, 29% of respondents cited long-term safety data, 22% wanted before/after clinical data, like lab results, and 20% valued self-reported symptom improvement. Yet the strongest signal from the research was a clear consumer struggle to access straightforward information on side effects and product use, highlighting transparency in these areas as one of the most pressing unmet needs in consumer health.
"People want to know that the health products they purchase will work as intended and not come with negative side effects," said Malcolm Fogarty, Strategic Advisor for Partnerships and Growth at Lindus Health. "These findings underscore a growing need for clear, readily available, evidence-backed communication in consumer health, especially as new products and technologies emerge."
The availability of clinical evidence, or a lack thereof, plays a major role in consumer purchase decisions. Around 46% of respondents indicated they either have decided against a purchase or stopped using a product due to a lack of clear information or evidence. This points to a major gap in consumer confidence that would be solved by access to additional information and education.
Additionally, consumer skepticism around new digital health tools could be impacted by these same concerns. Only 29% reported the use of use digital health technologies, while the majority continue to rely on old standbys— like vitamins and supplements (84%) and OTC medications (59%)— that often have years of research data and widespread confidence behind them, leaving a divide between the "tried and true" solutions and new options.
Lindus Health is poised to address this "trust gap" by delivering high-quality clinical trials, real-world evidence (RWE) studies, and health claims research for consumer health products backed by robust data, so consumers can make more informed purchasing decisions.
"The best way to bridge this divide is through high-quality evidence generation—and that's where Lindus comes in," said Meri Beckwith, Co-CEO of Lindus Health. "By executing research with consumers' needs top-of-mind, we're capturing the data we need so consumers can trust the health products they regularly buy are both safe and effective without sacrificing affordability."
The results of the survey reinforce the vital need for patient-centric clinical research and are being used to strengthen and refine trial designs that build consumer trust and support the adoption of safe, effective health products and digital tools — ultimately elevating the standards for more accessible healthcare.
About Lindus Health
Lindus Health is the anti-CRO running radically faster, more reliable clinical trials for life science pioneers—bringing ground-breaking treatments to patients more quickly. Through a performance-based pricing model, a world-class clinical operations team, a proprietary software platform, and access to over 40 million Electronic Health Records, Lindus Health delivers clinical trials with unmatched speed, reliability, and impact.
The company removes the biggest bottleneck in healthcare—clinical trials—through end-to-end study execution powered by technology and forward-thinking approaches to clinical operations. Lindus Health works with leading biotech, medical device, diagnostics, and consumer health companies to accelerate the development of innovative therapies and products. Its impact has been recognized with prestigious accolades, including the Fierce CRO Awards for Outstanding Patient Recruitment and Retention and inclusion in the PM360 Elite 100.
To date, Lindus Health has delivered trials across the US, UK, and Europe in conditions ranging from diabetes and asthma to major depressive disorder, hypertension, and chronic fatigue syndrome. The company has raised over $80M from investors including Balderton Capital, Peter Thiel, Creandum, Firstminute Capital, and Seedcamp.
New Study Boosts Trial Precision in Measuring Pain, Mood, and Fatigue
Pain, mood, and fatigue are among the hardest outcomes to measure in clinical research, largely due to their highly subjective nature. A newly published study in *The Journal of Pain * offers a simple method to efficiently perform a covariate adjustment that significantly improves how these "high-variability" endpoints are analyzed.
In the peer-reviewed study, the authors provide guidance on how to use composite baseline covariates to comply with FDA guidance and to optimize data analysis. In one real-world Phase III acute lumbar pain case study, selecting and building prognostic covariates, based on patient factors, increased trial precision. Additionally, when researchers applied composite psychological predictors from Cognivia's Placebell platform, results improved even further up to 23.4%. Placebell automates the creation of these predictors, making this approach scalable and repeatable across studies, giving it broad implications beyond pain trials.
"Trials too often fail, not because therapies are ineffective, but because the signals get lost in noise," said Dominique Demolle, PhD, CEO and Co-Founder of Cognivia. "This study shows a clear, validated path for tackling that noise, without additional patients, delays or cost."
Covariate adjustment is a regulator-supported method that accounts for differences between patients, such as psychological or baseline traits, to reduce noise in outcomes like pain, mood, or fatigue. Though backed by FDA guidance, covariate adjustment remains underused. Cognivia is the first life sciences technology company to offer a practical roadmap for implementing covariate adjustment in real-world trials, with guidance that is easy to apply and proven effective across three separate studies. While demonstrated in a pain trial, the approach applies broadly to any study with subjective or high-variability endpoints, including not only studies around the central nervous system, fatigue, or conditions involving emotional or mental health symptoms but also in many other therapeutic areas and indications.
"This approach is a game changer for trials with subjective endpoints displaying a high variability," said Samuel Branders, Cognivia's Director of Data Science and co-author of the study. "It helps produce clear, more trustworthy results and makes better use of patient resources by increasing precision without inflating sample size."
The study titled, From theory to practice: Simple rules for improving clinical trial confidence with covariate adjustment, was published in the September 2025 edition of the Journal of Pain. Additional authors include Arthur Ooghe, Alvaro Pereira, Luana Colloca, Elizabeth Standard, Chris Ambrose, and Dmitri Lissin.
Media Contact: cognivia@knbcomm.com
About Cognivia
Cognivia is the first and only company to combine quantification of patient psychology with artificial intelligence / machine learning (ML) to improve measurement of therapeutic efficacy in clinical trials and beyond. Cognivia technologies predict patient behavior and treatment response in clinical trials using predictive ML powered algorithms based on quantitative understanding of patient psychological traits, expectations and beliefs collected via our own and specific questionnaires developed toward that objective. Cognivia aims at harnessing "the power of the mind" and quantifying this unique phenomenon to improve clinical trial success rates, de-risk drug development and ultimately improve healthcare.
SOURCE Cognivia