Past News Items - February 2012

Computer-tailored intervention (CTI) programs applying the Transtheoretical Model (TTM) of behavior change to exercise and stress management programs simultaneously reduced participants’ health risks while improving multiple areas of well-being. Areas of well-being that were particularly impacted included: physical health, emotional health, life evaluation and healthy behaviors, according to a new study presented today at the Population Health and Care Coordination Colloquium in Philadelphia.

Participants in a telephonic coaching program group, with exercise as the primary target behavior and stress management as a secondary target, improved healthy behaviors pertaining to exercise (57.3 percent) and stress management (74.9 percent). Those in a web-based program group, with stress management as the primary target behavior and exercise as a secondary target, also reported healthy behavior change pertaining to exercise (46.6 percent) and stress management (64.7 percent). Both of these groups were significantly more likely to achieve treatment success than the control group, which did not receive telephonic or online interventions for exercise or stress management.

"We know that well-being measures how we feel and experience our daily lives in addition to being predictive of future healthcare cost," said Dr. James Pope, vice president and chief science officer, Healthways, Inc. "This study adds to that knowledge by showing that cost-effective programs, conducted via telephone or online, adequately provide the support required to help populations improve health and well-being, resulting in lower healthcare costs across the board."

Although a variety of behaviors relate to well-being, such as physical health, happiness and quality of life, healthcare costs, exercise and effective stress management were chosen as the two health behaviors having the greatest potential for changing multiple domains of well-being. Exercise has been found to produce over 60 different benefits, including reduction of depression, decreased pain, increased self-esteem, greater energy and increased productivity. In addition, effective stress management has been found to decrease stress and depression, improve sleep, decrease pain and increase productivity.

Exercise and stress management interventions were chosen since these behaviors were anticipated to have effects on multiple aspects of well-being and would be important components of a well-being improvement system, if proven effective. Results from the trial demonstrated that multiple areas of well-being did show improvement. Those areas of well-being not showing significant change, such as an individual’s access to healthcare or work environment, were not expected to show changes.

About the Study

The study was conducted on 3,391 individuals by Pro-Change Behavior Systems and the Center for Health Research, Healthways, Inc. Both treatment groups included CTIs with tailoring based on an individual’s state of change for a given behavior. The secondary behaviors in each intervention received stage matched tailoring, which only tailors on stage of change by giving guidance on the one or two steps that could lead to the next stage. This type of protocol can simultaneously treat multiple behaviors while reducing the treatment demands on participants and providers.

The exercise coaching group received up to three proactive telephone sessions at 0, 3 and 6 months via outreach by a trained health coach. Coaches used the CTIs to guide all sessions with optimal TTM tailoring for exercise and stage-tailoring for stress management, the secondary target. The CTI led the coaches through a series of assessment questions and tailored feedback, based on stage of change and TTM variables, to guide their participants to the next stage of change. Each telephone session lasted about 20 minutes. The stress management online group received a self-directed Web-based intervention with full TTM tailoring for stress management and stage-based tailoring for exercise.

These two treatments were used, in part, because telephonic coaching and online CTIs represent the two most commonly applied modalities of scalable wellness interventions. This study was not designed, however, to compare whether telephonic coaching produces greater impact than online CTIs or whether exercise, as the primary behavior, is more effective than stress management.

About Participants

Participants were recruited via the Internet through a survey sampling company that has a national pool of about 1,500,000 potential participants. To be eligible, participants had to report risk in the areas of both exercise (not engaging in moderate or vigorous exercise to guidelines) and stress (reporting stress that was not being managed effectively) during the screening process.

For more information about Healthways, visit healthways.com.

Released: 02/27/12

Metagenics’ One-of-a-Kind PhytoMulti Supplement Now Available with Iron

Metagenics Inc., a nutrigenomics and lifestyle medicine company focused on improving health, today released PhytoMulti with Iron, an enhanced modification that adds iron to the original PhytoMulti supplement. PhytoMulti is known as the “Smart Multi” for its ability to target cellular health by nourishing cells, recharging cellular communication and defending against free radical damage. The PhytoMulti with Iron supplement supports Metagenics’ 2012 "Year of You” campaign providing simple, healthy resolutions and nutritional protocols to improve health.

“PhytoMulti with Iron delivers the same tested cellular support and health benefits found in the original PhytoMulti supplement with the addition of iron, a mineral necessary for proper blood cell function that helps protect against chronic diseases like anemia and fatigue,” said Joseph Lamb, MD, Director of Intramural Clinical Research for Metagenics. "Like PhytoMulti, PhytoMulti with Iron is the only professional brand daily supplement that undergoes an unparalleled, sophisticated level of scientific validation. Now, people who need the added benefits of supplemental iron can receive the recommended dose from PhytoMulti with Iron.”

PhytoMulti with Iron is particularly beneficial for women from 18 to peri-menopause who need to consume additional iron in their diet, as well as individuals that may not receive enough iron in their normal diets, such as vegetarians.

PhytoMulti and PhytoMulti with Iron are specifically designed to activate health potential with a science-based combination of phytonutrients, vitamins and minerals. An independent laboratory evaluated PhytoMulti’s proprietary blend and the entire combination of active ingredients with the new total functional oxygen radical absorbance capacity (ORAC) assay that measures against five major free radicals. Unlike a conventional ORAC, which tests against only one radical, this expanded in vitro assay provides a better sense of antioxidant protection against a variety of potentially damaging free radicals and other reactive oxygen species. An analysis of PhytoMulti's active ingredients (equivalent to the contents in one tablet) showed a total ORAC value of 12,600 trolox, demonstrating exceptional antioxidant capacity.

The potential of the phytonutrient blend to help maintain DNA stability was validated using the COMET assay, a complex in vitro test using human immune cells. This assay demonstrated a 52 percent increase in DNA stability when cells pretreated with the phytonutrient blend were compared to control cells introduced to the same oxidative medium (peroxides).

PhytoMulti with Iron contains a combination of plant extracts with complex phytonutrients and additional phytonutrients that were selected for their targeted support for cellular health and function, as well as for their positive influence in multiple pathways and health systems. In addition to iron and the phytonutrient blend, PhytoMulti with Iron also delivers a concentrated daily dose of:

Clinically effective levels of select plant bioactives—resveratrol, lutein, zeaxanthin and lycopene—to support health of the eyes, liver, heart, and more
An optimized blend of essential minerals and vitamins, including vitamin forms designed for greater bioavailability

In the “Year of You” program, PhytoMulti with Iron is an option to complement a variety of personalized protocols to promote wellness and vitality . The goal of this year-long program is to introduce patients to science-based products that support long-term health. Other featured components include the Identi-T™ stress management protocols and the Wellness Essentials line of daily packet products that provide a personalized combination of Metagenics formulas, including PhytoMulti and PhytoMulti with Iron.*

For additional information please visit metagenics.com or call 1.800.692.9400.

Released: 02/27/12

Metagenics Inc. Introduces New Wellness Essentials Personalized Daily Nutrition Packets

Seven Specialized Combination Formulas to Support Overall Health, Joint Health, Pregnancy, Healthy Blood Sugar Balance, and Healthy Aging in Women and Men

Metagenics Inc., a nutrigenomics and lifestyle medicine company focused on improving health, today announced seven Wellness Essentials products that feature once-daily packets of nutritional supplements backed by scientific research to support personalized daily nutrition. The Wellness Essentials product line offers seven specialized formula combinations that are convenient and easy to use. These formula combinations provide a foundation of essential vitamins and minerals, along with phyonutrients, concentrated omega-3s, and other targeted nutritional supplements to offer personalized health support.

“Our Wellness Essentials packets are developed through extensive research to meet the unique health needs of specific demographics,” said Deanna Minich, PhD, FACN, Vice President of Scientific Affairs at Metagenics. “These formula combinations incorporate advanced nutritional approaches, including science-based support for specialized applications—such as selective kinase response modulators (SKRMs) to impact healthy cellular communication—to deliver revolutionary foundation nutrition along with targeted health support. Doctors now have the option to choose a nutritional formula combination that will meet a patient's specific health needs.”

Every Wellness Essentials packet contains a minimum of 1000 mg of purity-tested omega-3 fatty acids, important for maintaining healthy blood lipids. The product line (excluding Wellness Essentials Pregnancy) also features the new PhytoMulti supplement that provides essential vitamins/minerals and a proprietary blend of 13 concentrated extracts and phytonutrients with scientifically tested biological activity to help protect cells and maintain DNA stability. Unlike common foundational nutrition packets, Wellness Essentials formulas are backed by a scientific review and quality standards to deliver nutrition that supports heart, brain, and immune health, as well as positive mood and vitality.

The Wellness Essentials product line:

Wellness Essentials supports immune and nervous system health
Wellness Essentials Men’s Vitality targets vitality and libido, as well as supports masculine functions and overall health
Wellness Essentials Women targets heart and bone health, as well as helps maintain vitality and overall health in women
Wellness Essentials Women’s Prime targets energy metabolism, heart and bone health, in addition to vitality and overall health in mature women
Wellness Essentials Pregnancy provides comprehensive nutritional support for preconception through nursing
Wellness Essentials Active targets healthy joint flexibility, mobility and comfort, as well as vitality and overall health
Wellness Essentials Healthy Balance supports healthy blood sugar and insulin levels that are already in the normal range, as well as overall health and well-being

The enhanced Wellness Essential formulas are part of Metagenics’ “Year of You” in-office program for healthcare practitioners—providing simple nutritional protocols and novel products to help patients make and keep resolutions to improve health. Other recent product introductions include the Identi-T Personalized Stress Relief Program and the “Smart Multi” formulas—PhytoMulti and PhytoMulti with Iron.

For additional information, please visit metagenics.com or call 1.800.692.9400.

Released: 02/27/12

Insight to Brain Connectivity in Chronic Low Back Pain Patients is Seen through a Novel Arterial Spin Labeling MRI Study

Researchers at Harvard Medical School used arterial spin labeling, a novel functional magnetic resonance imaging (fMRI) technique, to show for the first time that brain connectivity in patients with discogenic chronic low back pain (CLBP) changes in proportion to the severity of their pain. The study was presented today at the 28th Annual Meeting of the American Academy of Pain Medicine.

Marco Loggia, PhD, Postdoctoral Research Fellow at Harvard Medical School, Massachusetts General Hospital and Brigham & Women's Hospital, reported the results. The researchers used arterial spin labeling (ASL) to measure the cerebral blood flow to specific brain regions and assess the neural activity. In this particular study the authors performed sophisticated analyses on brain connectivity to determine how communication among areas is altered in CLBP patients.

After Institutional Review Board approval, 16 CLBP patients (average pain 4.8/10, average duration 6.2 years) and 16 matched healthy controls participated in two resting-state 6-minute ASL scans: one at baseline and one after the study subjects participated in clinical maneuvers (such as straight leg raising, or pelvic tilt) that were painful to the CLBP group, inducing a clinically significant increase in ongoing pain (>30 percent), but not to the healthy control group.

Through the ASL images, the researchers found that at baseline the CLBP patients had a stronger connectivity between a particular brain region, the medial prefrontal cortex (MPFC), and a network of brain areas, the "Default Mode Network" (DMN), than the healthy controls. The results also showed that the more the DMN was connected to the MPFC, the less the pain experienced. This suggests that MPFC-DMN connectivity might be a pain-protective mechanism.

The analysis also showed that the connectivity between the MPFC and the DMN was reduced after the maneuvers in patients (but not in the controls). "Since painful maneuvers disrupt these connectivity patterns, we believe that the higher connectivity strength observed at baseline might reflect some type of a coping or compensatory mechanism, as if the patients, while at rest, are bracing for the next pain increase," comments Dr. Loggia.

The authors also observed that the greater the pain, the more the DMN was connected to the insula, a region considered to be involved in pain processing. Furthermore, the greater the pain increased after the clinical maneuvers, the more the DMN-insula connectivity also increased. This was of particular interest to the researchers because a study published last year found similar results between the DMN-insula connectivity in fibromyalgia patients. The researchers also believe that such fine tracking of the pain perception suggests that the DMN-insula connectivity might actually encode the perceptual aspect of the clinical pain. This appears to be a general feature of chronic pain that may cross over multiple pain conditions.

"Today there are no objective tests to evaluate the amount of pain experienced by a patient. The only way to assess it is simply to ask the patient, but of course self-report is a far-from-perfect measure, and cannot be obtained for everybody (e.g., preverbal children, patients with severe dementia, etc). This study suggests that pain severity in a chronic pain population might be objectively measured by examining brain activity. One day, these methods may translate into clinical applications, and perhaps be used to improve the design of clinical trials," comments Dr. Loggia.

"ASL is a promising tool to investigate the neural processing of chronic pain and provides a step forward in the quest for objective biomarkers in the study of chronic pain. Future studies should focus on linking such brain connectivity to changes in pain over time," Dr. Loggia concludes.

For more information about the American Academy of Pain Madicine, visit painmed.org.

Released: 02/26/12

Metagenics Launches FirstLine Therapy Certification Programs for Healthcare Providers to Address Metabolic Syndrom

Certification programs designed to educate healthcare providers on how to successfully implement lifestyle medicine approaches to resolve issues associated with metabolic syndrome.

From March 1-4 in Boston, Massachusetts, Metagenics, Inc. will launch the first of eight FirstLine Therapy Certification programs to be held in 2012. These programs prepare physicians, osteopaths, naturopathic physicians, functional medicine providers and their staffs to practice lifestyle medicine with a complete practice management system from clinical tools and protocols to business office management. A particular focus for FirstLine Therapy is the treatment of metabolic syndrome, a condition that affects one in three US adults and increases the risk of heart disease and diabetes.

“Lifestyle medicine therapies are the recommended approach to treat many common health issues associated with metabolic syndrome,” said Jacob Kornberg MD, FACS, Director of Professional and Clinical Services for Metagenics. “However, healthcare practitioners are not trained in how to actually follow these recommendations in their practices. The FirstLine Therapy program gives them all the tools they need to comply with these recommendations, and to help their patients achieve better health by addressing the cause, not just the symptoms, of their condition.”

“The future of health in our country will become more focused on preventative medicine and nutrition that help to stop chronic illness before it begins,” said Ted Brooks, MD, senior partner at Derry Medical Center. “FirstLine Therapy is a restorative lifestyle program that puts patients back in control of their health. It is important that providers are educated about this treatment to better serve and care for their patients.”

Metabolic syndrome is defined as the presence of at least three of five symptoms: high blood pressure, elevated triglycerides, high blood sugar, abdominal obesity or low HDL cholesterol. Research has shown that people with metabolic syndrome are twice as likely to have heart disease and five times as likely to develop diabetes.

Metagenics’ FirstLine Therapy program offers an evidence-based, clinically effective system to achieve optimal patient and practice success. The certification programs will cover the most effective ways to prescribe and personalize the FirstLine Therapy program to patients, the key functional biomarkers and laboratory values for assessing these patients, and how to conduct and read bioelectrical impedance analysis (BIA) to monitor body composition for patient tracking and motivation—all in a case study and workshop based format.

This program also provides a structured system to teach patients behavior modification for a lifetime approach to healthy living, including recommendations for phytonutrient-rich eating, exercise and stress management. FirstLine Therapy also incorporates products such as Metagenics UltraMeal Plus 360? medical food, which was demonstrated in a recent multicenter clinical trial at the Universities of Florida, Connecticut and California, to resolve metabolic syndrome 40 percent faster in conjunction with the FirstLine Therapy food plans compared to diet alone.

To assist practitioners in making the change, Metagenics is now offering a complimentary post-certification support program via phone, online and email notifications to help them successfully implement the FirstLine Therapy program into their practice.

The certification programs are open to prescribing healthcare providers and designated Lifestyle Educators who help educate, motivate and monitor metabolic syndrome patients. The programs will be held in the following locations throughout 2012:

Boston, MA from March 1-4
San Diego, CA from April 19-22
Kansas City, MO from May 17-20
New York, NY from June 7-10
Toronto, ON from July 19-22
Atlanta, GA from September 20-23
San Francisco, CA from October 19-21
Vancouver, BC from November 8-11

The speaker team of experienced clinicians, FirstLine Therapy Program developers and implementation experts presenting this program include: Kristi Hughes, ND, the Associate Director of Medical Education at the Institute for Functional Medicine; Kenneth Browning, DO, a family medicine practitioner for over 25 years; Lyra Heller, MA, co-founder of Metagenics and co-architect in the development of the FirstLine Therapy curriculum; and Chris Katke, co-founder of Metagenics and FirstLine Therapy educator.

To learn more about the FirstLine Therapy Program or to register for a certification program, visit metagenics.com/flt.

Released: 02/23/12

CT Colonography Shown to be Comparable to Standard Colonoscopy for People Ages 65 and Over

A recent analysis of data collected in the National CT Colonography Trial conducted by the American College of Radiology Imaging Network (ACRIN) confirms the efficacy of the exam as a front line colorectal cancer screening tool for seniors.

Computerized tomographic (CT) colonography (CTC), also known as virtual colonoscopy, is comparable to standard colonoscopy in its ability to accurately detect cancer and precancerous polyps in people ages 65 and older, according to a paper published online today in Radiology.

This is consistent with results of the ACRIN National CT Colonography Trial, published in the New England Journal of Medicine in 2008, which demonstrated that CT colonography can serve as a primary colorectal cancer screening option for adults ages 50 and older, but did not specifically break out data for participants ages 65 and older included in the overall analysis. The Centers for Medicare and Medicaid Services have deferred coverage for CT colonography, primarily citing a lack of data on the exam’s performance in Medicare-eligible recipients ages 65 and older.

"Our goal in carrying out this secondary analysis was to determine if the accuracy of CT colonography to detect polyps of clinical concern in patients 65 and older is comparable to the test’s accuracy for the 50 and over population studied in the 2008 ACRIN trial. We found no significant difference in the screening exam’s performance between the two age groups," said C. Daniel Johnson, MD, of the Mayo Clinic in Scottsdale, AZ and principal investigator of the National CT Colonography Trial and the paper’s primary author.

"CT colonography is a perfectly viable colorectal cancer screening tool for the traditional Medicare age population. Wider availability made possible by Medicare coverage of CT colonography would attract more seniors to be screened for colorectal cancer—which is so successfully treated when detected early. Making CT colonography more available to seniors ultimately could save lives," summarizes Johnson.

The National CT Colonography Trial recruited 2,600 study participants ages 50 and over from 15 US medical centers to compare the accuracy of state-of-the-art CT colonography to the gold standard of conventional colonoscopy. Ninety percent of the polyps 1 centimeter or larger—the polyps most likely to become cancerous—were detected by CT colonography. Polyps as small as one-half centimeter were also detected by CT colonography with a high degree of accuracy.

In the secondary analysis of the 65 and over cohort, data were available for 477 study participants. The percentage of participants with large polyps was significantly greater among the older participant group (3.7 percent for aged < 65 vs. 6.9 percent for = 65); however, even if intermediate-sized polyps of 6mm or larger were targeted for removal with standard colonoscopy, the colonoscopy referral rate would not exceed 12.6 percent.

ACRIN Chair Mitchell J. Schnall, MD, PhD, Matthew J. Wilson Professor of Research Radiology at the University of Pennsylvania, comments, "These results demonstrate the wealth of data that are collected in ACRIN clinical trials that can be used to explore important cancer screening and other research questions. For example, ACRIN has undertaken another study leveraging the National CT Colonography Trial data investigating the prevalence and type of incidental findings reported as part of a CT colonography examination to better understand their impact and to develop guidelines for the reporting and management incidental findings.

CT colonography employs virtual reality technology to produce a three-dimensional visualization that permits a thorough and minimally invasive evaluation of the entire colon and rectum. The ACRIN trial is the largest multi-center study to compare the accuracy of state-of-the-art CT colonography to the gold standard of conventional colonoscopy in patients 50 and older. Colorectal cancer is the third most frequently diagnosed cancer and second leading cause of cancer death in men and women in the United States. Yet, despite the known benefits of screening, studies indicate that millions of Americans age 50 and older are not being screened for the disease.

For more information about ACRIN, visit acrin.org.

Released: 02/20/12

New, clinically validated, natural solution for occasional anxiety introduced to the United States

Lavela For the first time, an exclusive lavender (Lavandula angustifolia) essential oil indicated for occasional anxiety is being introduced to the United States. This clinically validated oil – Lavela WS 1265 is available through the practitioner exclusive brand - Integrative Therapeutics.

Indicated for occasional anxiety, Lavela WS 1265 (referred to as Silexan in published research), has been shown to promote relaxation and calm nervousness with safety and efficacy, as demonstrated in controlled trials published in peer-reviewed medical journals. Lavela WS 1265 offers relief without the side effects commonly seen in other options. Taken just once a day, this gentle, yet powerful, essential oil is non-habit-forming and well-tolerated. Clinical trials and a comparative analysis suggest that the effects of Lavela WS 1265 compare favorably to other options.

Integrative Therapeutics adds this product to a line-up of other clinically-validated natural products, including ViraClear EPs 7630.

To find out more about Integrative Therapeutics, LLC, please visit integrativeinc.com.

Released: 02/16/12

New National Study Shows Integrative Medicine Commonly Used to Treat Chronic Health Conditions

Seventy-five percent of integrative medicine centers included in a new study about integrative practice reported success treating chronic pain. More than half of centers reported successfully using integrative medicine to treat gastrointestinal conditions, depression/anxiety, cancer, and stress.

Integrative Medicine in America: How Integrative Medicine Is Being Practiced in Clinical Centers Across the United States, a new study from The Bravewell Collaborative, looked at the patient populations and health conditions most commonly treated with integrative medicine.

"With chronic health issues costing the economy more than $1 trillion a year, it's essential to find the best treatments and preventive practices," said Donald Abrams, MD, co-author of the report and professor of clinical medicine at the University of California San Francisco. "The broader use of integrative medicine could fundamentally change how patients are being served in this country."

Twenty-nine integrative medicine centers were surveyed, including programs at Cleveland Clinic, Duke, Mayo Clinic, Stanford and MD Anderson Cancer Center. All participating centers reported being affiliated with hospitals, health systems and/or medical and nursing schools, suggesting that integrative medicine has now become an established part of healthcare in the US.

All of the centers in the study served adult patients and many treated older people (97 percent), adolescents (86 percent), children (62 percent) and individuals at the end of life (66 percent).

Integrative medicine is an evidence-based approach to care that puts the patient at the center and addresses the physical, emotional, mental, social, spiritual and environmental influences on health. The center directors reported that their centers most frequently prescribe, often in tandem, food/nutrition therapies (65 percent), supplements (60 percent), yoga (55 percent), meditation (51 percent), traditional Chinese medicine/acupuncture (50 percent), massage (49 percent), and pharmaceutical interventions (46 percent).

Sixty-two percent of the centers have also incorporated lifestyle change programs that emphasize healthy behaviors and actions. As shown in many studies published over the past five years, attention to healthy diet, exercise and stress reduction can help prevent major health issues.

"There is great potential for integrative medicine to help prevent illness and foster lifelong health," explained Christy Mack, President of The Bravewell Collaborative. "This report suggests that integrative approaches offer promise for increasing the effectiveness of care." To view the full report, Integrative Medicine in America, online, visit bravewell.org.

Released: 02/16/12

New Study Shows a Free Plant Based Sterol/Stanol Dietary Supplement, CholestOff, Significantly Lowers “Bad” Cholesterol Levels by Almost 5 Percent

This cholesterol lowering occurred on top of the 5 percent reduction of LDL cholesterol with use of the NCEP’s TLC Diet.

A study published in the November 2011 International Journal of Food Sciences and Nutrition demonstrated nearly 5 percent reduction in “bad” low-density lipoprotein (LDL) cholesterol when CholestOff was added to the National Cholesterol Education Program (NCEP) therapeutic lifestyle changes (TLC) diet. CholestOff is a dietary supplement containing 1.8 grams of free (non-esterified) phytosterols.

“The results of this study are both statistically significant and clinically relevant,” said study co-author, Kevin C. Maki, PhD. “The study demonstrates that this supplement containing free (non-esterfied) phytosterols, when added to the NCEP’s TLC diet, significantly reduced the levels of both total and LDL (bad) cholesterol among the study participants, all of whom had elevated cholesterol initially. The FDA has concluded ‘[t]he scientific evidence establishes that including phytosterols in the diet helps to lower blood total and LDL cholesterol levels’ and this study demonstrates that this dietary supplement formulation of free (non-esterified) phytosterols perform this function.”

Most clinical trials examining the effects of phytosterols on cholesterol have used food forms including margarine-type spreads, orange juice, yogurt and yogurt-based drinks. In contrast, few have investigated the effects of phytosterols as supplements. The US Food and Drug Administration concluded in 2010 that the formulation of phytosterols in dietary supplements can play an important role in cholesterol reduction in addition to a healthy diet and exercise.

The study enrolled 32 men and women, aged 21 to 79 years, in good general health but with fasting levels of LDL cholesterol ranging from 131 to 220 mg/dl. The supplement, CholestOff, provided 1.8 grams daily of free plant sterols and stanols via four tablets daily (two tablets with each of two meals).

For this double-blinded crossover study, participants first followed the TLC diet and used a placebo for five weeks. Then investigators randomized the patients to six weeks of the TLC diet with either a free-phytosterols dietary supplement or the same number of matching placebo tablets followed by six weeks in which the participants switched to the opposite treatment while remaining on the TLC diet. The investigators measured the effects of the treatments by comparing the cholesterol levels at the study start to the average of the levels measured at the last two weeks of each treatment period.

This double-blind crossover study shows that consuming a supplement containing 1.8 grams daily of free plant sterols and stanols, a naturally occurring plant-based ingredient, while following the NCEP’s TLC diet significantly reduced the LDL-C levels of participants by 4.9 percent (P=0.002) after six weeks of treatment, compared to participants consuming the NCEP diet with a placebo. There were no statistically significant or clinically relevant changes in the patients’ vital signs, body weight or non-lipid clinical laboratory values.

“This study adds to the body of knowledge that supports the use of this dietary supplement of phytosterols in the appropriate daily dosages as an effective approach to lower LDL cholesterol in conjunction with a healthy diet and exercise program,” said Belinda H. Jenks, PhD, Director of Scientific Affairs & Nutrition Education at Pharmavite LLC., and coauthor of the study. “These study results could be useful to healthcare providers and their patients considering options to reduce bad cholesterol,” continued Jenks “especially as this free-phytosterols supplement, CholestOff, can easily be added to a cholesterol-lowering regimen without negatively impacting a person’s diet or caloric intake.”

Released: 02/16/12

Metagenics, Inc. Introduces New Wellness Essentials Personalized Daily Nutrition Packets

Metagenics, Inc., a nutrigenomics and lifestyle medicine company focused on improving health, today announced seven Wellness Essentials products that feature once-daily packets of nutritional supplements backed by scientific research to support personalized daily nutrition. The Wellness Essentials product line offers seven specialized formula combinations that are convenient and easy to use. These formula combinations provide a foundation of essential vitamins and minerals, along with phytonutrients, concentrated omega-3s, and other targeted nutritional supplements to offer personalized health support.*

The Wellness Essentials product line:

Wellness Essentials supports immune and nervous system health*
Wellness Essentials Men’s Vitality targets vitality and libido, as well as supports masculine functions and overall health*
Wellness Essentials Women targets heart and bone health, as well as helps maintain vitality and overall health in women*
Wellness Essentials Women’s Prime targets energy metabolism, heart and bone health, in addition to vitality and overall health in mature women*
Wellness Essentials Pregnancy provides comprehensive nutritional support for preconception through nursing*
Wellness Essentials Active targets healthy joint flexibility, mobility and comfort, as well as vitality and overall health*
Wellness Essentials Healthy Balance supports healthy blood sugar and insulin levels that are already in the normal range, as well as overall health and well-being*

For additional information, please visit metagenics.com.

*These statements have not been evaluated by the Food & Drug Administration. These products are not intended to diagnose, cure or prevent any disease.

Released: 02/15/12

Cleveland Clinic Joins 23andMe in the Search for Genetic Clues to Parkinson's Disease

In an effort to study the interactions between genomics and Parkinson's disease, Cleveland Clinic has joined the ongoing efforts of 23andMe, a leading personal genetics company, to recruit Parkinson's patients to participate in research by contributing their DNA to a research database and completing online surveys about their health.

Currently, little is known about how genes relate to Parkinson's disease, the effectiveness of treatments, or the natural course of the disease. The goal of this collaborative research effort—which also has support from the Michael J. Fox Foundation, the National Parkinson Foundation and the Parkinson's Institute—is to discover how genes and the environment influence Parkinson's disease.

"We are aware of the limitations of today's treatments, so we are always thinking about what we can do to advance the care of this incurable disease," said Andre Machado, MD, PhD, Director of Cleveland Clinic's Center for Neurological Restoration. "This collaboration will help us to learn more about the genomics of Parkinson's disease and how it may impact individualized care in the future."

The project is part of Cleveland Clinic's personalized healthcare initiative, which aims to drive discoveries that allow medical professionals to better predict risk for disease and response to therapies, with the ultimate goal to improve patient care.

"We are offering this opportunity to our patients because as part of our 'Patients First' mission, we feel it is an important collaboration that could lead to improvements in our ability to predict and treat Parkinson's disease," said Kathryn Teng, MD, Director of the Center for Personalized Healthcare at Cleveland Clinic. "Donating saliva, blood or tissue for research is a form of 'Patient Philanthropy.' It empowers our patients to participate in medical research and discoveries that can improve healthcare for themselves and others."

Patients who volunteer for the study will be asked to provide a saliva sample for DNA analysis and agree to participate in online surveys about their experience with Parkinson's. 23andMe hopes to enroll 10,000 participants total; Cleveland Clinic expects to enroll about 1,000 patients toward this goal.

"The quality of the research will depend heavily on sample size. Patient enrollment and participation is critical to the success of the project," said Ryan Walsh, MD, PhD, Director of the Parkinson's Disease and Movement Disorders Program at the Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas.

Patients who take part in the study will be enrolled in 23andMe's Parkinson's Disease Research Community, which will allow them to engage online with other Parkinson's patients and provides full access to 23andMe's Personal Genome Service.

23andMe first assembled its Parkinson's disease research initiative in June 2009. Within an 18-month period, 23andMe assembled and analyzed genetic data from more than 3,400 Parkinson's patients and successfully replicated the top 20 previously known genetic associations with Parkinson's disease in addition to determining new genetic associations for Parkinson's. Those findings were published in PLOS Genetics in June 2011. That study identified two novel loci, rs6812193 near SCARB2 and rs11868035 near SREBF1/RA11 and replicated those loci in an independent data cohort from the National Institute of Neurological Disease and Stroke (NINDS) database.

"We are very excited to be partnering with Cleveland Clinic and Dr. Machado. Integrating their clinical care with our online research model creates the opportunity for a new paradigm of medical research, that will ultimately benefit individuals with Parkinson's Disease," said Anne Wojcicki, CEO of 23andMe. "Participants enrolled through the Cleveland Clinic will join the more than 6,500 individuals with Parkinson's disease already in our research community – the largest cohort of Parkinson's patients in the world."

Participation is free and voluntary. Those who take part in the study will be identified by a unique code, not by their names, in order to protect their privacy. Participants can choose to receive a report summarizing the genes identified in their DNA, though these findings will not be placed in their medical record.

"Patients volunteering for the study are unlikely to benefit directly, but they can have a sizable role in improving care for future patients. That's what this partnership is all about for us," said Hubert Fernandez, MD, Section Head, Movement Disorders at Cleveland Clinic's Center for Neurological Restoration.

To facilitate participation in the registry, Cleveland Clinic has detailed information and dedicated computer portals set up at locations where Parkinson's patients are most likely to be visiting, including main campus in Cleveland and the Lou Ruvo Center for Brain Health in Las Vegas. Two additional locations, Cleveland Clinic's Lakewood Hospital (Lakewood, Ohio) and Cleveland Clinic Florida (Weston, Fla.), will be enrolling patients as well.

For more information about the research study, visit https://www.23andme.com/pd/.

Released: 02/15/12

Valkee and University of Oulu Publish the First Clinical Trial on Bright Light Therapy Channeled via ear Canals in Seasonal Depression

Valkee, the inventor of the bright light headset, and scientists from the University of Oulu published the first results of the clinical and neurobiological research program conducted since 2007, on human brain's light sensitiveness. The clinical trial, published in Medical Hypothesis, studied therapeutic effects of bright light channeled into the human brain via the ear canal.

"There is no conclusive evidence that light therapy is only transmitted through the eyes. On the contrary, in mammals, a significant amount of light penetrates the skull and reaches the brain. The brain has photoreceptive proteins such as encephalopsin, and physiological influences have been measured by extra ocular light exposure. Therefore, we challenged the existing paradigm by showing that the brain-targeted bright light therapy via the ear canal is an effective mechanism to relieve seasonal depression," comments Juuso Nissilä, Valkee's co-founder and chief scientist.

In the published trial, patients received 8-12 minutes of 6.0-8.5 lumen bright light daily into both ear canals for four weeks with a medical Class II(a) device manufactured by Valkee Ltd, called bright light headset. The daily administration time was personalized at the study clinic.

"The results are strong and promising. 92 % of the patients with severe seasonal affective disorder achieved full remission measured by the self-rated BDI-21 questionnaire. With the psychiatrist-rated HAMD-17 questionnaire, 77 % of the patients achieved full remission," comments Professor Markku Timonen, MD, PhD, and the lead investigator for the published trial at the University of Oulu. The full remission criteria was BDI-21 and HAMD-17 sum score ≤ 7.

Valkee introduced its bright-light headset in August 2010 and has today broad user base. Being based on cross-functional science in neurology, biology, psychiatry and physiology in University of Oulu, Finland, Valkee is a CE-certified Class II (a) medical device under the EU regulations.

For more information about Valkee, visit valkee.com.

Released: 02/14/12

Metagenics’ Chief Science Officer, Dr. Jeffrey Bland, Is Awarded Nutrition Business Journal’s 2011 Education Award

Jeffrey Bland, PhD, chief science officer for Metagenics, Inc., a nutrigenomics and lifestyle medicine company dedicated to reducing chronic illness and improving health, has been awarded the 2011 Nutrition Business Journal’s (NBJ) Education award for his expertise and contributions to international nutritional medicine education. The NBJ awards give recognition to the industry’s influential leaders who have made a significant impact in the fields of health, wellness and nutrition.

“I am honored to receive the Nutrition Business Journal’s Education award,” said Dr. Bland. “Educating healthcare practitioners in the science of nutrigenomics is the key to reversing the tide of chronic illness that is currently overwhelming our healthcare system worldwide. As more and more practitioners and patients discover the power of lifestyle medicine to achieve life-long health, we are at the tipping point of shifting our focus from treating disease to creating health.”

For more than 25 years, Dr. Bland has been an internationally recognized leader in the nutritional medicine field. A nutritional biochemist, he is a prominent researcher and educator for the science of nutrigenomics, the study of how nutritive substances and phytochemicals affect genetic expression within human cells.

Dr. Bland currently serves as the chief science officer for Metagenics and is the president of Metagenics’ wholly owned subsidiary, MetaProteomics Nutrigenomics Research Center. His scientific team has published more than 80 peer-reviewed articles and been awarded more than 50 international or domestic patents. Their research is the foundation for Metagenics’ industry-leading products and programs that reduce chronic illness and improve health.

In addition to lecturing and teaching on nutrigenomics around the world, Dr. Bland leads and shapes hundreds of educational programs offered through Metagenics University, including the certification programs for First Line Therapy (FLT), a personalized lifestyle program centered on therapeutic lifestyle change.

Dr. Bland’s leadership in nutrigenomics education also includes achievements such as:

Professor of biochemistry at the University of Puget Sound.
Director of nutritional research at the Linus Pauling Institute of Science and Medicine.
First member of the board of trustees of Bastyr University, the first federally accredited university in the United States offering graduate and undergraduate degrees in natural medicine. Dr. Bland contributed significantly to its founding and accreditation.
Establishment of the Institute of Functional Medicine to educate clinicians about functional medicine.
President at the Northwest Academy of Preventive Medicine
Author of the textbook, The Medical Applications of Clinical Nutrition, that has been used in numerous medical and graduate school curriculums.

Dr. Bland will be publicly honored for his outstanding achievements in nutrition medicine education at the 15th annual NBJ Summit in Dana Point, California, on July 24-27.

For more information about Metagenics, Inc., visit metagenics.com.

Released: 02/10/12

Largest-Ever Gene Study of Type 2 Diabetes Finds Variants across Many Ethnic Groups

The largest genetics study to date of type 2 diabetes (T2D) has identified new gene variants associated with risk for the common metabolic disease. An international scientific consortium, studying multiethnic populations, uncovered genes that may point to biological targets for developing more effective drugs for T2D.

Multiple genes and environmental factors interact with T2D, which affects nearly 300 million people worldwide. The majority of the gene variants remain undiscovered.

"Scientists have identified only about 10 percent of the genetic variants contributing to T2D, and most previous studies have been based on people of European ancestry," said senior co-author Brendan J. Keating, PhD, of the Center for Applied Genomics at The Children's Hospital of Philadelphia. This international study found that many gene variants associated with T2D overlap across multiple ethnic groups." The current study included subjects with African-American, Hispanic, Asian and European ancestry.

The study appears online today in the American Journal of Human Genetics. The study's other senior co-author was Richa Saxena, PhD, from Massachusetts General Hospital and Harvard Medical School.

The research consortium performed a meta-analysis of 39 existing studies of multiethnic populations, comprising over 17,000 cases of individuals with T2D, compared to 70,000 control subjects. This large-scale genetic screening used a customized gene analysis tool to examine 50,000 genetic variants across 2,100 genes known to be associated with cardiovascular and metabolic functions.

The researchers identified variants in four previously unknown genes associated with T2D, discovered six new independent genetic signals in known T2D genes, and verified 16 previously reported T2D-linked variants. A total of nearly 40 gene variants have now been found to raise or lower the risk of T2D. Keating says the current study's genome-wide screening approach in large multi-ethnic samples should be effective in discovering additional diabetes gene variants relevant to multiple ethnic populations.

Type 2 diabetes, previously called non-insulin dependent diabetes or adult-onset diabetes, accounts for 90 to 95 percent of all diabetes. It is a chronic metabolic disease in which the body produces insufficient insulin or becomes unable to properly process insulin it does produce. While the risk of T2D generally rises with age, the disorder has been significantly increasing among children and adolescents.

"As we continue to identify more genes associated with type 2 diabetes, we expect that further investigation of their specific biological functions will guide researchers toward new therapies for preventing and treating this disease," said Keating.

The two main groups funding this study were the National Heart, Lung and Blood Institute of the National Institutes of Health through the Candidate Gene Association Resource (CARe) study and the British Heart Foundation. Many other funding sources supported the 39 studies contributing data to this meta-analysis. Among other senior investigators from The Children's Hospital of Philadelphia were Hakon Hakonarson, MD, PhD, director of the Center for Applied Genomics, and Struan F.A. Grant, PhD, associate director of that center.

"Large-Scale Gene-Centric Meta-Analysis across 39 Studies Identifies Type 2 Diabetes Loci," American Journal of Human Genetics, published online Feb. 9, 2012, to appear in print, March 9, 2012. doi: 10.1016/j.ajhg.2011.12.022

For more information about The Children’s Hospital of Philadelphia, visit chop.edu.

Released: 02/10/12

Healthy Nurses Self-Medicate

Nurses have long witnessed how a cheerful attitude makes a positive impact on a patient's health and healing. Most would agree laughter is the best medicine. This spring hundreds of nurses will test that theory on themselves during the 25th Annual Association for Applied and Therapeutic Humor (AATH) Conference April 19-22 at the Westin O'Hare.

"It's time nurses took a dose of their own medicine," says conference co-chair Deb Hart, RN, who makes humor and laughter central to her work as a mental health nurse and Certified Laughter Leader in St. Joseph, IL. "Nurses are so busy lifting the spirits of those they care for, they often forget to replenish themselves. Prioritizing themselves and having fun are critical."

During the AATH conference, healthcare workers will experience hours of much needed laughter while exploring the science behind it. They will learn first hand how colleagues from around the globe apply therapeutic humor, and how a workforce of happy nurses improves patient safety and workplace satisfaction.

Karyn Buxman RN, MSN, CSP, CPAE, an icon in the therapeutic humor movement who has worked with both Norman Cousins and Patch Adams and co-founded The World Laughter Tour, will facilitate a special track of healthcare programming on Friday, April 20. Topics include the latest research and applications in the areas of humor and health, aging, grief, education, and professional practice. For deeper study, AATH offers the Humor Academy, a multi-option curriculum through which participants earn a certificate and/or graduate level credit.

"Stressed-out healthcare workers can turn to unhealthy behaviors and substances in order to cope," says Buxman. "If you are tempted to self medicate, laughter and humor are healthier alternatives. Laughter is free of charge, readily available, and contagious - in a good way. Side effects include better health, improved decision making, and happier living."

Author of the book What's So Funny About Diabetes? Buxman emphasizes the importance of using appropriate humor at the appropriate time, something AATH members take seriously.

Nurses can choose from 26 hours of continuing education credit and will earn 15 credits during the general conference and another 3 for enrolling in the Humor Academy. For more information or to register visit www.aath.org.

Released: 02/10/12

Release of FDA Guidance for Biosimilars Pathway Marks Important Step Forward, Says BIO

Patient Safety Must Remain Top Priority

Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood issued the following statement regarding the newly released US Food and Drug Administration (FDA) guidance for the review and approval of biosimilars:

“Today the FDA announced specific guidance for the review and approval of biosimilars, medicines that are similar to, but not exact replicas of, innovator biologics. Biologic therapies save, extend and improve the quality of life for patients living with debilitating diseases including cancer, HIV/AIDS, multiple sclerosis, and a host of rare and orphan diseases.

“We are pleased that the FDA has developed these important guidances, marking another important step forward on the pathway to biosimilars. We look forward to reviewing the drafts in detail to ensure that they comply with our key principles, particularly ensuring patient safety, recognizing scientific differences between drugs and biologics, maintaining the physician-patient relationship and preserving incentives for innovation.

“In addition, BIO believes that careful post-market monitoring of the safety of a biologic, whether an innovator or biosimilar, is critical and should be funded by user fees. BIO supports timely authorization of the biosimilars user fee agreement, which will provide FDA with the resources and capacity to evaluate biosimilars products and support biosimilar post-market safety activities, while continuing to prioritize the review of innovative new medicines for unmet medical needs.

“BIO encourages the FDA not t