Revolutionary Nutraceutical Addresses an Unfilled Gap in Postmenopausal Bone Health

Ostera™: Revolutionary Nutraceutical Addresses an Unfilled Gap in Postmenopausal Bone Health

San Clemente, CA (March 9, 2009) — Metagenics, Inc. said today that it has launched a new nutraceutical called Ostera. This unique nutritional supplement supports the special needs of postmenopausal women, whose bone health may be affected by declining estrogen levels.*

Ostera is formulated to target bone remodeling, the normal lifelong process whereby old or damaged bone tissue is replaced by new bone tissue.

Conventional approaches to postmenopausal bone health may have adverse affects or not be well-tolerated. By contrast, Ostera is a gentle, all-natural formula without reported serious adverse effects.

Ostera is intended to complement natural bone mineralization support products, such as calcium and other minerals.* Its active ingredients are:
· Extracts from berberine and rho iso-alpha acids from hops — key botanical compounds shown to beneficially influence key markers of bone remodeling. In postmenopausal women, a decline in estrogen levels can contribute to changes in bone remodeling, where the rate of bone breakdown outpaces the rate of new bone formation.*
· Vitamin K – necessary for the metabolism of bone proteins crucial to bone integrity.*
· Vitamin D – associated with healthy bone formation and bone mineralization.*

Ostera was developed using Metagenics’ proprietary nutraceutical development model called the ExpresSyn® process. This exclusive model combines cellular research, safety evaluations, human ex vivo research, and clinical research. Through the ExpresSyn Process, Metagenics researchers have discovered a new generation of natural ingredients, such as acacia and hops, which function at the cellular level as selective kinase response modulators (SKRMs).*

Clinical research included a randomized, single-blinded, placebo-controlled study in which 77 postmenopausal women with low estrogen were placed on a lifestyle change program that included a Mediterranean-style, low-glycemic-load diet and 150 minutes of moderate exercise per week. The participants in the “Ostera arm” received the supplement twice daily for twelve weeks following a two-week run-in phase. The participants in the “control arm” received a placebo.

According to Joseph J. Lamb, MD, Metagenics Director of Intramural Clinical Research, “The Ostera arm reported no serious adverse affects and showed greater improvement in key biomarkers of bone remodeling.”* These biomarkers included:
· Osteocalcin (OC), an indicator of the rate of bone remodeling. A lower level of serum OC, moving towards reference range, is associated with a slower rate of bone breakdown in postmenopausal women. The Ostera arm displayed a statistically significant reduction in serum OC, while the control arm displayed an increase.*
· Insulin-like growth factor-1 (IGF-1), a recognized marker of bone formation and important in the maintenance of a healthy skeleton. IGF-1 declines after menopause. Both arms displayed a statistically significant increase in serum IGF-1; however the Ostera arm showed a greater average increase.*
· Vitamin D, which influences bone formation and is critical for calcium absorption to facilitate mineralization. The Ostera arm displayed a statistically significant increase in vitamin D status. The control arm displayed a decrease.*
· OC/Urinary N-telopeptide of type 1 procollagen (NTx), a marker of bone resorption. Ostera arm participants with high baseline NTx levels displayed a statistically significant reduction in serum OC. Control arm participants with high baseline NTx levels displayed an increase in serum OC.*

“Early on, we identified a need for a clinically tested, all-natural formula to support healthy bone remodeling,” said Lamb. “We believe Ostera fills that gap, thereby providing a further degree of support to postmenopausal women for whom bone mineralization support products, such as calcium and other minerals, may not be enough.” As with all Metagenics nutritional formulas, Ostera is only available through licensed health care practitioners.

Individuals interested obtaining Ostera should contact their health care professionals.

About Metagenics, Inc. Metagenics, headquartered in San Clemente, CA, is a global life sciences company focused on reversing chronic illness and improving health. Founded in 1983, the company serves tens of thousands of health care professionals and more than a million patients throughout the world and holds more than 40 propriety formula patents for use in nutraceucials, medical foods, and pharmaceuticals. Today, Metagenics continues its leadership role by successfully merging the disciplines of nutritional genomics, functional medicine, and therapeutic lifestyle change programs to find solutions to society’s most pressing health concerns.

*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. ####

Measuring the Pollution in People

A number of striking studies (i) have shown that the man-made chemicals in our environment and in consumer products—including cosmetics—make their way into our bodies. Many of the chemicals found in cosmetics are absorbed by the skin into the body, and can be detected in blood or urine.

The length of time chemicals remain in the body varies from chemical to chemical and ranges from hours to decades. For chemicals that are excreted quickly, the fact that we can so consistently measure them indicates continual exposures that may have long-term effects on health.

Body Burden and Biomonitoring
Body burden refers to the levels of man-made chemicals in an individual’s body, generally measured through blood or urine. Large-scale biomonitoring programs that assess the levels of chemicals in a population or subset of a population would greatly support the ability of researchers to explore the links between exposures and disease. A gap in determining the long-term effects of chemical exposures upon disease has long been a lack of knowledge about chemical exposures and the intake of environmental toxins into the body. Ongoing biomonitoring programs would fill this vital data gap.

The Pollution in People
The largest U.S. body burden study to date measured the levels of 148 chemicals in approximately 3,000 people of varying ages, ethnicities and geographical locations (ii). This study, by the U.S. Centers for Disease Control, detected a common sunscreen ingredient, benzophenone-3 (BP-3) in 96.8 percent of individuals (iii), and triclosan, an antibacterial agent often used in antibacterial soaps, in 74.6 percent of individuals (iv). A CDC study found residues of four different phthalates in more than 75 percent of subjects (v). Phthalates are found in numerous cosmetics, often as a constituent ingredient of fragrances. A 2008 study of teen girls by the Environmental Working Group revealed 16 hormone-altering cosmetics chemicals in their young test subjects (vi).

The CDC tests of 148 chemicals represents a very small percentage of the over 80,000 chemicals manufactured and the approximately 10,000 chemicals used in cosmetic products. The next edition of the CDC report, anticipated in 2009, will include measurements of 250 chemicals, an increase that still doesn't approach the total number of chemicals in commerce. Nevertheless, this and other studies illustrate that chemicals we use in an array of consumer products make their way into our bodies (vii). This knowledge also furthers our understanding of the links between the chemicals we use, the absorption of these chemicals into our bodies, and the known and probable health effects of these chemicals.

i.Commonweal Biomonitoring Resource Center (2005). Taking It All In: Documenting Chemical Pollution in Californians through Biomonitoring. Available online at http://www.commonweal.org/programs/download/TIAI_1205.pdf. Accessed August 19, 2008.

Environmental Working Group (2006). Across Generations: Industrial Chemicals in Mothers and Daughters: The pollution we share and inherit. Available online at http://www.ewg.org/reports/generations/. Accessed August 19, 2008.

Environmental Working Group (2005). Body Burden: The Pollution in Newborns. Available online at: http://www.ewg.org/node/17686. Accessed August 19, 2008.

Environmental Working Group (2003). Body Burden: The Pollution in People. Available online at: http://archive.ewg.org/reports/bodyburden1/. Accessed August 19, 2008.

ii Centers for Disease Control and Prevention (CDC) (2005). Third National Report on Human Exposure to Environmental Chemicals. Available online at http://www.cdc.gov/exposurereport/. Accessed December 23, 2008.

iii Calafat AM, Wong LY, Ye X, Reidy JA, Needham LL. Concentrations of the Sunscreen Agent, Benzophenone-3, in Residents of the United States: National Health and Nutrition Examination Survey 2003-2004. Environ Health Perspect 116:893–897 (2008).

iv Calafat AM, Ye X, Wong LY, Reidy JA, Needham LL. Urinary Concentrations of Triclosan in the U.S. Population: 2003–2004. Environmental Health Perspectives, 116:303–307 (2008).

v Silva MJ, Barr DB, Reidy JA, Malek NA, Hodge CC, Caudill SP, Brock JW, Needham LL, Calafat AM. “Urinary Levels of Seven Phthalate Metabolites in the U.S. Population from the National Health and Nutrition Examination Survey (NHANES) 1999-2000,” Environmental Health Perspectives, 112(3): 331-338 (2004).

vi Sutton, R (2008). Teen Girls' Body Burden of Hormone-Altering Cosmetics Chemicals. Available online at http://www.ewg.org/reports/teens. Accessed October 10, 2008.

vii Commonweal and Breast Cancer Fund (2005). Taking It All In: Documenting Chemical Pollution in Californians through Biomonitoring. Available online at http://www.commonweal.org/programs/download/TIAI_1205.pdf. Accessed August 19, 2008.

Environmental Working Group (2006). Across Generations: Industrial Chemicals in Mothers and Daughters: The pollution we share and inherit. Available online at http://www.ewg.org/reports/generations/. Accessed August 19, 2008.

Environmental Working Group (2005). Body Burden: The Pollution in Newborns. Available online at: http://www.ewg.org/node/17686. Accessed August 19, 2008.

Environmental Working Group (2003). Body Burden: The Pollution in People. Available online at: http://archive.ewg.org/reports/bodyburden1/. Accessed August 19, 2008.

Rising Star of Brain Found to Regulate Circadian Rhythms

Apr 14 2011

BOSTON (April 14, 2011, noon ET) — The circadian system that controls normal sleep patterns is regulated by a group of glial brain cells called astrocytes, according to a study published online on April 14th in Current Biology, a Cell Press publication. Neuroscientists from Tufts University School of Medicine found that disruption of astrocyte function in fruit flies (Drosophila) led to altered daily rhythms, an indication that these star-shaped glial cells contribute to the control of circadian behavior. These results provide, for the first time, a tractable genetic model to study the role of astrocytes in circadian rhythms and sleep disorders.

According to the National Institute of Neurological Disorders and Stroke, more than 40 million Americans suffer from sleep disorders. Some sleep disorders arise from changes to the internal clock that is modulated by environmental signals, including light. Biologically, the internal clock is known to be composed of a network of neurons that controls rhythmic behaviors. Rob Jackson and his team previously had found that normal circadian rhythms require a glial-specific protein. In the new study, the team demonstrates that glia, and particularly astrocytes, are active cellular elements of the neural circuit that controls circadian rhythms in the adult brain.

“This is significant because glia have been traditionally viewed as support cells rather than independent elements that can regulate neurons and behavior. Neurons have had center stage for some time but current research is establishing the role of glial cells in brain function,” said Rob Jackson, PhD, professor of neuroscience at Tufts University School of Medicine (TUSM) and member of the genetics and neuroscience program faculties at the Sackler School of Graduate Biomedical Sciences at Tufts. Jackson is also the director of the Center for Neuroscience Research (CNR) at TUSM.

“We used cellular and molecular genetic techniques to manipulate glial cells in the adult brain of fruit flies and found that such cells regulate neurons of the circadian network and behavior,” said first author Fanny Ng, PhD, a postdoctoral associate in the Jackson lab. Ng added, “this is the first study to show that glia can modulate the release of a neuronal factor that is essential for normal circadian behavior.”

Jackson’s team observed altered rhythms in locomotor activity with glial manipulations, an indication the circadian clock had been disrupted, which in humans can contribute to jet lag or serious sleep disorders.

“In order to develop treatments for these disorders, we need to understand their cellular and molecular bases. Our work suggests that Drosophila can serve as a model system for genetic and molecular approaches to understand astrocyte function and astrocyte-neuron interactions. This undoubtedly will contribute to a better understanding of sleep and other neurological disorders that result from circadian dysfunction,” said Jackson.

An additional author on this paper is Michelle Tangredi, PhD, a graduate of the Sackler program in neuroscience and a postdoctoral associate in Jackson’s lab.

This research was funded by grants from the National Heart, Lung, and Blood Institute and the National Institute of Neurological Disorders and Stroke (NINDS) and a training grant from the National Institute of Child Health and Human Development, all of the National Institutes of Health, and an award from the Russo Family Charitable Foundation Trust through TUSM. The Center for Neuroscience Research is funded by NINDS and Tufts University.

Ng FS, Tangredi MM, and Jackson FR. Current Biology. “Glial cells physiologically modulate clock neurons and circadian behavior in a calcium-dependent manner.” DOI 10.1016/j.cub.2011.03.027

About Tufts University School of Medicine and the Sackler School of Graduate Biomedical Sciences

Tufts University School of Medicine and the Sackler School of Graduate Biomedical Sciences at Tufts University are international leaders in innovative medical education and advanced research. The School of Medicine and the Sackler School are renowned for excellence in education in general medicine, biomedical sciences, special combined degree programs in business, health management, public health, bioengineering and international relations, as well as basic and clinical research at the cellular and molecular level. Ranked among the top in the nation, the School of Medicine is affiliated with six major teaching hospitals and more than 30 health care facilities. Tufts University School of Medicine and the Sackler School undertake research that is consistently rated among the highest in the nation for its effect on the advancement of medical science.

Do women experience more pain than men?

Mar 9 2011
Wendy Williams, associate director of the Pain Research, Education and Policy Program, responds

The answer seems to be that they do. Many studies indicate that women notice pain at lower stimulus thresholds than men, and cannot tolerate pain as long as men. Even after experiencing the same surgical procedures, women report more intense pain than men.

These differences might be related to hormone levels, specifically estrogen and related hormones. Some studies indicate a pattern of increased sensitivity to pain prior to the menstrual phase. This seems to occur across various painful conditions, ranging from irritable bowel syndrome and temporomandibular joint disorder (TMD) to headaches.

The work reinforces other findings, such as that during pregnancy, when estrogen levels are high, women experience less pain from migraines and TMD. These studies are a recent advance over traditional research, which predominantly used male mice and rats and overlooked the importance of gender.

Another theory being studied is that women experience more pain because they are genetically predisposed to be on the alert for impending danger, especially to protect their offspring. Related to that is the idea that women in our culture have more freedom to express pain than men, which might play a role in how women actually sense painful stimuli. There is also a question as to whether females express pain sooner to engage others to give support. The theory is that females utilize the social connections they have for coping in general, so expressing their distress around pain may be a way to signal others that they need support.

Regardless of the roles that hormones or sex differences may exert on the perception of pain, the social pressure to be “a nice patient” should never cause a woman to suffer in silence if she has new symptoms or if ongoing treatment for an existing problem is inadequate.