In the News

IFM Governing Board Welcomes New Members

Scientists Bioengineer Human Liver Disease in the Lab to Find New Treatments

New Research Examines Blueberries' Effect On Cardiometabolic Health In Adults With Metabolic Syndrome

Published Study Demonstrates Feasibility of a Blood Test to Predict Disease Progression and Metastasis in Localized Prostate Cancer

Proton Therapy Shown to Reduce Side Effects for Multiple Cancers

OmegaQuant Wins Award for Its 'Prenatal DHA Initiative'

P. Michael Stone, MD, MS, Receives the Linus Pauling Award in Functional Medicine

IFM Governing Board Welcomes New Members

The Institute for Functional Medicine has named two new members to its governing board of directors. During what has been a period of rapid growth and burgeoning interest in Functional Medicine, IFM continues to respond to these growing needs by engaging wider areas of expertise and spheres of influence to support the organization at every level.

The governing board is expanding its membership to include expertise and representation from diverse sectors including health systems and healthcare policy, strategic partnerships, patient advocacy, asset and intellectual property management, international collaborations, communications, business development, public affairs, and strategic planning. During the board of directors’ recent meeting, held in conjunction with IFM’s Annual International Conference, two new members were elected and join current directors Jeffrey Bland, PhD, Laurie Hofmann, MPH, Mark Hyman, MD, David Jones, MD, Joseph Pizzorno, ND, and Juliet Rogers, PhD, MPH.

New governing board member Terry Cook brings decades of expertise in the areas of financial asset and risk management as well as business development, strategic planning, and high-level problem solving. He is founder of The Cascade Group of UBS Private Wealth Management and leads a team of professionals who guide successful business owners through life-changing liquidity events. An established financial services professional of more than 25 years, Terry has been named the number one wealth advisor in the state of Washington for the last three years by Forbes.

Also joining IFM’s governing board is Kara Dowdall, MS, a highly respected executive and leader in the fields of health care and clinical operations management. Kara is vice president of operations for reliance Surgeons, one of the largest surgical practices in the country. Additionally, she is one of the first national board certified health and wellness coaches and serves as a Functional Medicine health educator. She is also the founder of Intellect Health, LLC, a healthcare and practice management consulting firm. Kara’s record of success spans more than 30 years.

IFM chairwoman Laurie Hofmann states, “Terry and Kara are valuable additions to our governing board. As IFM continues to execute an ambitious strategic plan, the need to identify and engage individuals who represent wider fields of expertise is vital. We are excited to have Terry and Kara join us as we further our mission to advance the widespread adoption of Functional Medicine.”
IFM extends a warm welcome to them both.

About The Institute for Functional Medicine (IFM): IFM is the global leader in Functional Medicine. The mission of IFM is to serve the highest expression of individual health through the widespread adoption of Functional Medicine. For more information about IFM, please visit IFM.org.

For more information:
Melanie De Bond
Associate Director of Communications
[email protected]
253.661.3016

Scientists Bioengineer Human Liver Disease in the Lab to Find New Treatments

Scientists successfully bioengineered human liver organoids that faithfully mimic key features of fatal liver disease in the laboratory. This allowed them to uncover underlying disease biology in the organoids and test a potential therapy that in preclinical lab tests reversed an often-fatal childhood condition called Wolman disease.

In findings published online by the journal Cell Metabolism, researchers at Cincinnati Children's Hospital Medical Center say their study overcomes major hurdles to unraveling the molecular mysteries of liver diseases and finding desperately needed new therapies. It also leads to personalized methods to study inflammation and fibrosis in liver disease that match the unique genetics and biology of individual patients, according to study authors.

"Although current human organoid systems can recreate organ architecture in living lab organisms like mice, they fail to capture the complex pathologies of inflammation and fibrosis in liver diseases," said Takanori Takebe, MD, lead study investigator and a physician at the Cincinnati Children's Center for Stem Cell and Organoid Medicine (CuSTOM). 

"We developed a reproducible method to bioengineer complex, multicellular human liver organoids using pluripotent stem cells derived from healthy human donors and those with liver disease," he said. "These organoids generate different types of liver cells like hepatocytes, stellate and Kupffer-like cells, and they accurately recreate in the lab inflammation, fibrosis and other features of liver disease.''

That is significant because years of attempted drug development for conditions like fatty liver disease (NASH, NAFLD, etc.) and Wolman have been hindered by a lack of human disease models that accurately mimic the diseases, Takebe said. And although certain animal models like mice are available, they aren't always reliable for studying human disease.

The study is a collaboration of scientists at Cincinnati Children's, the Institute of Research at Tokyo Medical and Dental University (TMDU) in Japan (where Takebe is also a member of the medical staff), and researchers at four other institutions in Japan and the United States.   

Often Silent Killers

One challenge of battling liver disease is it can be a silent killer, producing few initial symptoms that might prompt early, proactive medical treatment.

Wolman disease is a genetic disorder that results in deficiency of an enzyme called lysosomal acid lipase (LAL), which breaks down fats in the body, according to the National Institutes of Health. Without the enzyme, fats over-accumulate in liver tissues and cause bloating, swelling of the stomach, vomiting and an enlarged liver or spleen, leading to life-threatening complications.

In nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH), fat accumulation, inflammation and fibrosis cause serious harm to the liver, an organ that helps the body digest food and filter out toxic substances. The causes of NAFLD and NASH remain under investigation, although research points to certain health conditions that make fatty liver disease more likely, such as obesity or insulin resistance. Research also points to exposure to certain medications, toxins or diseases as potential but less common causes.  

Finding Possible Solutions

In this study, Takebe and colleagues used 11 different lines of healthy and diseased pluripotent stem cells to generate complex multi-cellular human liver organoids. The diseased pluripotent cells included those grown from donors with a deficiency in the LAL protein.

The researchers treated the organoids with free fatty acids—byproducts of fat metabolism in fatty tissue. This helped drive liver fat accumulation, inflammation and fibrosis. The organoids were able to recreate liver disease in the lab in a step-by-step, successive manner similar to Wolman disease in children.

As liver disease developed in the organoids, researchers used an extremely high-resolution imaging technology called atomic force microscopy. This allowed them to demonstrate and observe progressive levels of organ stiffening that they said confirms the increasing severity of accumulating liver fibrosis.

After concluding that Wolman disease in the human organoids was caused by LAL deficiency, the researchers were able to reverse that deficiency by exposing the organoids to a recombinant LAL protein. Next, study authors leveraged earlier research that shows LAL deficiency causes over activation of a protein called mammalian target of rapamycin (mTOR), which is linked to liver fibrosis.

Previous research also shows that mTOR can be suppressed by a receptor protein called farnesoid X receptor (FXR), which functions in the nucleus of intestinal and liver cells. FXR upregulates and down-regulates genes that control fat metabolism and bile acid processes in the liver. Takebe and his colleagues decided to treat the human liver organoids with Wolman disease with an FXR agonist called obeticholic acid. FXR is an acid that synthesizes a protein called fibroblast growth factor 19 (FGF19) in the ileum of the small intestine.

FXR treatment suppressed fat accumulation in the human liver organoids and prolonged their survival. This opens the possibility of further preclinical testing to see whether or not FXR treatment might be an appropriate strategy for treating Wolman disease, according to study investigators. Because the study's findings are preclinical and involve laboratory models, additional research is needed to show whether the findings will apply to clinical treatment in patients.

Funding support came from the Cincinnati Children's Research Foundation, a grant from JST PRESTO (Japan Science and Technology Agency) and the Mirai Program (JPMJMI18CB), a Public Health Service grant (P30DK078392), the Takeda Science Foundation, the Japan Agency for Medical Research and Development (JP18fk0210037h0001, JP18bm0704025h0001, JP18H02800) and the National Institutes of Health (UG3DK119982). Takebe is a New York Stem Cell Foundation-Robertson Investigator.

SOURCE Cincinnati Children's Hospital Medical Center

New Research Examines Blueberries' Effect On Cardiometabolic Health In Adults With Metabolic Syndrome

A new research study published in the American Journal of Clinical Nutrition found that participants with metabolic syndrome who consumed the equivalent of one cup of fresh blueberries, given as 26g of freeze-dried blueberries, showed clinically relevant changes in measures of heart health. The study, "Blueberries improve biomarkers of cardiometabolic function in participants with metabolic syndrome – results from a 6-month, double blind, randomized controlled trial," was conducted at the University of East Anglia in the United Kingdom in collaboration with Harvard T.H. Chan School of Public Health and other UK institutions.

The study found that intake of the equivalent of one US cup per day of blueberries (given as 26g freeze-dried blueberries) resulted in clinically significant improvements in heart health measures, particularly markers of vascular function (blood flow and elasticity of the blood vessels by measuring endothelial function and arterial stiffness). Improved endothelial function and reduced arterial stiffness are associated with a reduced risk of cardiovascular events such as heart attack and stroke.ⁱ Importantly, the observed increases in nitric oxide bioactivity in the blood provided a potential mechanism for the endothelial function benefits observed.

Intake of one cup of blueberries per day also resulted in significantly increased HDL-C levels, also known as "good cholesterol," compared to the placebo. Additional lipid biomarkers researched in the study support these findings, such as significant increases in HDL particle number and APO-A1 levels, which are other predictors of heart disease risk.

Insulin resistance, pulse wave velocity, blood pressure, and other lipid levels (including total cholesterol) were unaffected by any of the interventions. There were also no observed clinical benefits from the intake of one-half cup of blueberries in this at-risk participant group.

Over a six-month period, 115 participants (78 men and 37 women) between the ages of 50 and 75 with metabolic syndrome, were randomly assigned to receive one of three daily treatments: 26g freeze-dried blueberries (the equivalent of one US cup/d); 13g freeze-dried blueberries (the equivalent of one-half US cup/d); or a placebo powder matched for color, taste and consistency. All study subjects were instructed to limit intake of other anthocyanin (the main natural flavonoid constituent present in blueberries) containing foods to one portion per week and other foods known to modify vascular function. Participants also refrained from blueberry intake beyond the assigned daily treatments.

Metabolic syndrome is a group of risk factors which includes low levels of HDL-C, or "good cholesterol," high blood pressure, increased abdominal obesity, high triglyceride levels, high blood pressure and high fasting glucose levels that raises risk for heart disease and other health problems, such as type 2 diabetes and stroke.ⁱⁱ It represents a health challenge that impacts more than one-third of the U.S. population. According to the Centers for Disease Control and Prevention, the percentage of Americans living with metabolic syndrome substantially increased from 25 percent between 1999 and 2006 to 34.2 percent between 2007-2012.ⁱⁱⁱ

"The results of this study provide the first evidence from a long-term study examining the impact of blueberry intake on clinically relevant measures of cardiometabolic health," said Aedin Cassidy, Ph.D., Head of Nutrition & Preventive Medicine Department and Chair of Nutritional Biochemistry at Norwich Medical School, University of East Anglia and the study's lead investigator. "While the conclusions drawn are from a single study that cannot be generalized to all populations, the data add weight to the evidence that a dietary intervention with a realistic serving of blueberries may be an effective strategy to decrease important risk factors for heart disease."

The research was funded by the U.S. Highbush Blueberry Council (USHBC). The USHBC had no role in study design, data collection, data analysis, data interpretation, or writing of the study. For more information on blueberry nutrition research visit blueberrycouncil.org/health-professionals/health-research/.

Published Study Demonstrates Feasibility of a Blood Test to Predict Disease Progression and Metastasis in Localized Prostate Cancer

Epic Sciences, Inc. announced today the publication of a six-year study demonstrating the clinical applicability of circulating tumor cells (CTCs) to predict prostate cancer progression and metastasis. The study, conducted in collaboration with the University of Michigan utilizing Epic's CTC technology platform, is published here in the Journal of Clinical Oncology Precision Oncology.

CTC-based assays are used to guide treatment decisions for patients with metastatic castration-resistant prostate cancer. This study sought to verify CTCs can be detected earlier in disease staging and whether associations relative to outcomes could be established. The study evaluated the associations between CTCs in the blood of 45 men diagnosed with high-risk, localized prostate cancer and prostate-specific antigen (PSA) recurrence and risk of metastasis. Study results found CTCs can be identified in most patients in this population at diagnosis and prior to surgery. The presence of CTC biomarkers was associated with patient biochemical recurrence and development of metastasis, supporting the evaluation of CTCs as a first step toward accurate risk stratification in this group of patients.

"Identifying which patients with prostate cancer are at risk of recurrence and metastasis is critical to making informed treatment decisions," said Todd Morgan, M.D., associate professor and chief of urologic oncology at Michigan Medicine and a member of the University of Michigan Rogel Cancer Center. "The potential to use a blood test to better predict patient outcomes is a tremendous opportunity for us to personalize patient care over the current standard-of-care."

Men with high-risk, clinically localized disease may harbor micro-metastasis that are not identified on imaging, often leading to undertreatment, which elevates the risk of prostate cancer-specific death in this patient population. This patient population is eligible for multi-modal therapy including surgery, radiation and systemic androgen deprivation therapy. Current risk stratification strategies evaluate pathology and clinical features to identify and predict which patients' disease is most likely to advance and determine who requires multimodal therapy. Recently, tissue-based gene expression tests have also demonstrated some prognostic value.

"The applicability of a blood test to identify failure of localized therapy could add significant value and advantages over tissue-based tests," said Rick Wenstrup, M.D., chief medical officer at Epic Sciences. "The ability of the Epic Sciences CTC platform to inform clinical questions in newly diagnosed, localized cancer patients represent an expansion of the clinical value of non-invasive CTC applications."

Proton Therapy Shown to Reduce Side Effects for Multiple Cancers

Proton therapy results in fewer side effects than traditional X-ray radiation therapy for many cancer patients, according to a new study led by Washington University School of Medicine in St. Louis and the Perelman School of Medicine at University of Pennsylvania.

The study included almost 1,500 patients receiving combined chemotherapy and radiation therapy for lung, brain, head and neck, gastrointestinal and gynecologic cancers that had not yet spread to other parts of the body. Such patients receive both radiation and chemotherapy, a treatment regimen that often cures nonmetastatic cancer, but can result in severe side effects leading to hospitalization.

"On a large-scale level across a variety of tumors, this study reinforces the general principle of radiation therapy treatment: less exposure to healthy tissue as achieved with proton therapy results in less damage," said Dr. Mark Storey, Medical Director, Clinical Operations, at the Oklahoma Proton Center.

After controlling for differences between the groups, such as age and additional medical problems, the researchers found that patients receiving proton therapy experienced a two-thirds reduction in the relative risk of severe side effects within 90 days of treatment, compared with patients receiving X-ray radiation therapy. Forty-five of 391 patients receiving proton therapy experienced a severe side effect in the 90-day time frame (11.5 percent). In the X-ray radiation therapy group, 301 of 1,092 patients experienced a severe side effect in the same period (27.6 percent).

n the release from Washington University, Dr. Brian Baumann, an assistant professor of radiation oncology at Washington University and an adjunct assistant professor of radiation oncology at Penn, commented: "The opportunity to reduce the risk of severe side effects for patients and thereby improve their quality of life is very exciting to me. While there have been other studies suggesting that proton therapy may have fewer side effects, we were somewhat surprised by the large magnitude of the benefit."

The researchers also found no differences between the two groups in survival, suggesting that proton therapy was just as effective in treating the cancer even as it caused fewer side effects. Overall survival at one year for the proton therapy group was 83 percent of patients versus 81 percent for the X-ray radiation therapy group.

"This is a tremendous study that reinforces the benefits of proton therapy and aligns with our mission - a cure is not enough; the quality of the life saved is just as important," said Dr. John Chang, Medical Director, Clinical Research and Education at the Oklahoma Proton Center.

This study is the first large review of data across several cancer types to show a reduced side-effect profile for proton therapy compared with X-ray radiation therapy for patients receiving combined chemotherapy and radiation.

Patients in the proton group had fewer side effects despite the fact that they were older — with an average age of 66 — than patients in the X-ray radiation therapy group — with an average age of 61.

About proton therapy:
Proton Therapy is the most precise form of radiation treatment for cancer available in the U.S. today. Unlike other forms of radiation used in cancer care such as X-Rays, protons stop inside tumors thus reducing the healthy tissue exposed to radiation during treatment. More than 175,000 patients have been treated with proton therapy worldwide and there are 31 proton centers currently in operation in the U.S. Proton Therapy is routinely used to treat solid tumors including prostate, breast, brain, head and neck, lung, esophageal, soft tissue and pediatric tumors.

About Oklahoma Proton Center
Oklahoma Proton Center ("OPC") is a state-of-the-art proton therapy center in Oklahoma City, OK. The 60,000 square foot facility opened in August of 2009 and has four treatment rooms that utilize the precision of proton particles to treat a variety of cancers. The center is attached to the INTEGRIS Cancer Institute. The combined comprehensive outpatient cancer facility is the largest community cancer center in the region offering proton therapy in conjunction with other advanced therapies for cancer. OPC is dedicated to excellent patient care and advancing proton therapy through innovation and clinical research.

OmegaQuant Wins Award for Its 'Prenatal DHA Initiative'

OmegaQuant is honored to have won the Nutraingredients-USA Award for its “Prenatal DHA Initiative,” which was presented June 3rd in conjunction with the IFT Show in New Orleans, LA. OmegaQuant was one of three finalists in the “Personalized Nutrition” category.

The Prenatal DHA Initiative was formed to bring more awareness to the importance of DHA intake, as well as knowing DHA status, among pregnant women and women who want to become pregnant. It was launched in February alongside the Prenatal DHA Test, which was invented by OmegaQuant and is currently patent-pending.

The Prenatal DHA Initiative involves a series of partnerships with health practitioners, brands, and organizations that can help educate the public and clinical community about the benefits of DHA in the diet, and specifically its ability to reduce the risk of preterm birth.
 
According to NutraIngredients-USA, the judges were impressed by the application of omega-3 testing to an especially sensitive population, to not only shine a light on the technology but also on the critical issue of omega-3 DHA intake during pregnancy and how to increase those levels.
 
Stephen Daniells, PhD, Editor-in-Chief of NutraIngredients-USA, commented: “Omega-3 status during pregnancy is a hugely important issue that has significant implications for mother and child, and our judges were impressed by the technology and the potential public health benefits of this initiative. This was a very competitive category, with three very strong finalists, so congratulations to the OmegaQuant team on the Prenatal DHA Initiative.”
 
“Most American women don't get enough DHA before or during pregnancy, so the Prenatal DHA Test can help personalize the issue and motivate women to get more DHA in their diet,” said Kristina Harris Jackson, PhD, RD, who invented the Prenatal DHA Test, alongside longtime omega-3 researcher Dr. William S. Harris, PhD.
 
Late last year, Drs. Jackson and Harris published a paper in the December edition of Nutrients that, for the first time, proposed an omega-3 DHA target blood level of 5% or higher for pregnant women, primarily based on research showing higher blood DHA levels and intakes reduces risk for early preterm birth. In this paper they also discuss the ramifications of low DHA levels among pregnant women and why they need to strive for a DHA level of 5% or above.
 
According to Drs. Jackson and Harris, ~70% of women of childbearing age in the US are likely below the DHA cut-point of 5%, and dietary intake data suggest that this group, including pregnant women, consumes just ~60 mg of DHA per day. Most experts recommend a minimum of 200 mg of DHA from fatty fish like salmon or an omega-3 supplement that contains DHA.
 
“Our ultimate goal is to help make pregnancy safer for women and their babies, which is why we want to bring more awareness to the importance of getting more DHA in the diet and using a Prenatal DHA Test to guide appropriate intake,” Dr. Jackson said.
 

Media Inquiries:
 
Becky Wright
Marketing & Communications Director, OmegaQuant
201-675-0197
[email protected]
 
 
About OmegaQuant: OmegaQuant is an independent, CLIA-certified lab that offers Omega-3 Index testing to researchers, clinicians and the public and sets the standard for fatty acid testing. OmegaQuant performs fatty acid analysis in Sioux Falls, SD for commercial and academic research collaborators, and for consumers interested in monitoring their nutritional status in both blood and breast milk. Its goal is to offer the highest quality fatty acid analytical services to researchers and to provide simple tests of nutritional status to consumers, with the ultimate purpose of advancing the science and use of omega-3 fatty acids to improve health. Most recently, it opened an additional lab in Brisbane, Australia. It also recently received approval in the EU market and opened a lab in Scotland, officially making the Omega-3 Index an internationally accessible test.
 
About the Nutralngredients-USA Awards: Focusing on true innovation, long-term market success and cutting-edge research, the Nutralngredients-USA Awards honor the best and brightest in ingredients, finished products, companies, people, and initiatives in the nutrition and dietary supplements industry. The Nutralngredients-USA Awards are organized by Nutralngredients-USA.com, the key news source for the functional food & beverage and dietary supplement industries. Covering scientific, regulatory and industry issues, the website offers a reference for all stakeholders in supplements and nutrition. Thanks to its blend of text, video and podcast content, the news can not only be read but also heard directly from the lips of the people making the headlines. For more information, please visit: www.nutraingredientsusa-awards.com

P. Michael Stone, MD, MS, Receives the Linus Pauling Award in Functional Medicine

The Institute for Functional Medicine (IFM) is proud to announce P. Michael Stone, MD, MS, as the 2019 recipient of the Linus Pauling Award in Functional Medicine. The Linus Pauling Award recognizes a visionary clinician or researcher who has made a significant contribution to the development of the Functional Medicine model or to the reach of Functional Medicine, nationally or internationally. Dr. Stone received this award for his work as a physician, researcher, innovator, and teacher.

From the beginning, Dr. Stone has been one of Functional Medicine’s unsung heroes and a cornerstone in Functional Medicine education. He attended the inaugural Applying Functional Medicine in Clinical  practice (AFMCP) program in 1998. It was there that he proposed, on the proverbial back of a napkin, the original idea that grew into what we now call the Functional Medicine Matrix Model. Dr. Stone has been one of IFM’s most valued educators, not only at AFMCP but also at the Cardiometabolic, Immune, and Hormone Advanced Practice Modules. He has spoken widely on Functional Medicine topics, including in China, Great Britain, South Africa, Hong Kong, and the Philippines.

Amy R. Mack, IFM’s chief executive officer, states, “Dr. Stone has been instrumental in the genesis of the Functional Medicine model and the concept of Functional Nutrition. He has worked tirelessly to develop practical applications for Functional Medicine, as he is first and foremost the consummate teacher and family physician. Michael embodies in heart and intellect what a functionally trained physician should aspire to be and is an inspiration to the Functional Medicine movement and community as a whole.”

Dr. Stone was central in promoting the importance of nutrition as a central concept in Functional Medicine, which began as a series of seminars that highlighted and foreshadowed the concepts of the ABCDs (Anthropometrics, Biomarkers, Clinical Indicators, and Diet and Lifestyle Journal) that later came to be called Functional Nutrition. Dr. Stone championed the idea of advanced training that expanded physical exam skills in order to detect nutritional imbalances. This initiative, after many years, came to fruition with the NutritionOriented Physical Exam video series, which is now a free clinical  resource IFM offers that includes clinical exam demonstration videos, an image library, quick reference and companion guides, and an extensive collection of relevant citations.

“Functional Medicine is changing our world—one life, one pregnancy, one child, and one family member at a time. It is transforming the way we approach health and disease in our clinics and hospitals. It helps infuse hope for finding an answer and decreases the despair of illness as healing occurs. This approach looks for and addresses the pillars of health and the imbalances of illness,” states Dr. Stone. “We use this Functional Medicine model to help parents, our children, and the next generation of clinicians to better pursue health and function from the earliest days of life. Functional Medicine changes the world perspective in families, communities, and now nations across the globe. Functional Medicine is improving the health of this and future generations. It encourages the best of medicine and life. I am humbled and honored to receive the Linus Pauling Award.”

The Linus Pauling Award in Functional Medicine has recognized a visionary clinician or researcher who has made a significant contribution to the development of the Functional Medicine model or to the extension of the reach of Functional Medicine, nationally or internationally, since 1996. For more information, visit IFM.org/LinusPauling.

About The Institute for Functional Medicine (IFM): IFM is the global leader in Functional Medicine. The
mission of IFM is to serve the highest expression of individual health through the widespread adoption of
Functional Medicine. For more information about IFM, please visit IFM.org.

For more information:
Tabitha Barth
IFM PR Coordinator
[email protected]
253.661.3013