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Past News Items - April 2022


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In the News

Treating chronic hypertension in early pregnancy benefits parents, babies

Ortho Molecular Products announces support for naturopathic residency consortium

FDA authorizes 1st breath test for COVID-19 infection

Quatrefolic® Increases Pregnancy Potential: New Study




Released: April 2022


Treating chronic hypertension in early pregnancy benefits parents, babies

Study shows pregnant adults less likely to experience preterm births or other serious problems with treatment .

Adults treated with medication for high blood pressure present before or during the first 20 weeks of pregnancy, defined as chronic hypertension in pregnancy, had fewer adverse pregnancy outcomes compared to adults who did not receive antihypertensive treatment, according to a study supported by the National Institutes of Health.

The study, which involved more than 2,400 pregnant adults, found that those who received medication to lower their blood pressure below 140/90 mm Hg were less likely to have a preterm birth or experience one of several severe pregnancy complications, such as preeclampsia, a condition marked by sudden high blood pressure and early signs of organ dysfunction. The hypertension treatment did not impair fetal growth.

“The impact of treating chronic hypertension during pregnancy represents a major step forward for supporting people at high risk for adverse pregnancy outcomes,” said Alan T. N. Tita, M.D., Ph.D., a principal investigator of the study and the John C. Hauth Endowed Professor of Obstetrics and Gynecology at the University of Alabama at Birmingham Marnix E. Heersink School of Medicine.

The findings from the Chronic Hypertension and Pregnancy(link is external) (CHAP) trial (NCT 02299414), currently the largest trial to study chronic hypertension in pregnancy, published simultaneously in the New England Journal of Medicine(link is external) and were presented on April 2 at the American College of Cardiology’s 71st Annual Scientific Session and Expo. The study is funded by the National Heart, Lung, and Blood Institute (NHLBI), part of NIH.

Diane Reid, M.D., a program officer in the Division of Cardiovascular Sciences at NHLBI, said early antihypertensive treatment could be significant for the thousands of U.S. adults who are at risk for preeclampsia or preterm births. Chronic hypertension in pregnancy occurs in more than 2% of people and can more than triple the risk for severe complications.

The CHAP trial enrolled pregnant people with hypertension at 61 U.S. medical centers from 2015-2021. At the start of the trial, hypertension was defined in this study as having systolic blood pressure (top number) above 140 mm Hg and diastolic blood pressure (bottom number) above 90 mm Hg. (Current guidelines define normal blood pressure for non-pregnant adults as less than 120/80 mm Hg.) Participants enrolled in the trial before 23 weeks of pregnancy. As part of the study, they were followed through delivery and for six weeks after giving birth.

Participants were randomized into one of two groups. Those in the intervention arm, 1,208 participants, received antihypertensive medication to keep their blood pressure below 140/90 mm Hg. Those in the control arm, 1,200 participants, did not receive medication to lower their blood pressure unless it rose above 160/105 mm Hg, a threshold for severe hypertension.

Researchers found that of the participants who received antihypertensive treatment, 70% experienced no major negative pregnancy outcome, while 30% experienced one of the following outcomes: preeclampsia with severe features, which usually presents after 20 weeks of pregnancy; placental abruption; preterm birth at less than 35 weeks; or fetal or neonatal death. In comparison, 37% of participants in the control arm experienced a similar negative event. In other words, the researchers said, for every 14-15 people treated for hypertension early in pregnancy, one was spared from experiencing a severe complication measured in the study.

Additionally, the birth weight of the infants did not appear to be affected by antihypertensive treatments. The birth weights of infants remained similar between groups – most had normal weights. Approximately 11.2% of babies born to participants who received medication and 10.4% of babies born to those in the control group had impaired fetal growth, which was defined as birth weight being below the 10th percentile for babies of the same gestational age.

“The study helps reassure that treating hypertension in pregnancy is safe and effective,” said Reid.

She explains the research will also help inform treatment decisions that have varied because of a shortage of evidence about the benefits of these antihypertensive medications, as well as their effects on fetal growth and development. Some medical organizations recommend the treatments; others discourage them, except in cases of severe hypertension. The authors note that this study should inform clinical practice guidelines.

The researchers also note the importance of future studies, such as those looking at long-term health outcomes of participants and their children, to further clarify the use of hypertension treatments during pregnancy.

To learn more about hypertension in pregnancy, visit https://www.nhlbi.nih.gov/health-topics/education-and-awareness/heart-truth/listen-to-your-heart/heart-health-and-pregnancy

To learn more about ways to support cardiovascular health at every age, visit https://www.nhlbi.nih.gov/health-topics/education-and-awareness/heart-truth.

Released: April 2022


Ortho Molecular Products announces support for naturopathic residency consortium

Ortho Molecular Products is proud to announce a partnership with Institute for Natural Medicine (INM) and its Residency Consortium, a premier, sustainable residency model for top naturopathic doctor (ND) graduates. The goal is to create a residency cohort model that will close the gap between medical doctor (MD) and ND post-graduate training.

The need for ND residencies is significant: Five out of every six graduates are seeking a residency, yet current residency programs lag in programmatic standardization across sites and lack systems to ensure a high level of focus and participation from residents. In addition, current residency programs do not provide business training.

“To level the playing field of post-graduate residency education, INM has designed a unique three-part-funding model to help expand primary care residency access. We partner with an academic institution, select vetted multi-practitioner naturopathic primary care clinics, and stakeholder corporations in the sector to help fund two-year primary care residencies,” explained INM president and CEO Michelle Simon, PhD, ND. “Ortho Molecular Products was one of the first companies I reached out to, recognizing a natural alignment with their mission to transform the practice of medicine. Their dedication to providing efficacious products for the supplement market and tools for providers and practices make them an ideal partner for our program.”

In addition to providing nutritional solutions and clinical resources, Ortho Molecular Products is an active supporter of community clinics operated by naturopathic medical schools, such as Southwest College of Naturopathic Medicine. The opportunity to support NDs on their post-graduate journeys to clinical practice was a natural fit for the organization.

“Naturopathic doctors are some of the highest-trained practitioners in functional integrative medicine, yet they are faced with considerable headwinds post-graduation and need more support within the medical community,” said Aaron Bartz, president of Ortho Molecular Products. “Our goal as an organization is to support NDs at every stage of their careers. We look forward to partnering with INM to prepare the next generation of naturopathic doctors to be successful in clinical practice.”

About Ortho Molecular Products

For more than three decades, Ortho Molecular Products has researched and manufactured high-quality, efficacious nutraceuticals sold exclusively to thousands of health care professionals nationwide and in Canada. Ortho Molecular Products is headquartered in the Chicagoland area, with an FDA-audited, cGMP-certified manufacturing facility in Stevens Point, WI. The commitment to efficacy, uncompromising manufacturing and legendary customer service establishes Ortho Molecular Products as a leader in the nutrition industry. To learn more, visit orthomolecularproducts.com.

About Institute for Natural Medicine

The Institute for Natural Medicine is a non-profit 501(c)(3) organization, in collaboration with the American Association of Naturopathic Physicians. The mission of the organization is to transform health care in America by increasing both public awareness of naturopathic medicine and access to naturopathic doctors for patients. To learn more, visit, naturemed.org.

Released: April 2022


FDA authorizes 1st breath test for COVID-19 infection

The Food and Drug Administration on Thursday issued an emergency use authorization for what it said is the first device that can detect COVID-19 in breath samples.

The InspectIR COVID-19 Breathalyzer is about the size of a piece of carry-on luggage, the FDA said, and can be used in doctor’s offices, hospitals and mobile testing sites. The test, which can provide results in less than three minutes, must be carried out under the supervision of a licensed healthcare provider.

Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, called the device “yet another example of the rapid innovation occurring with diagnostic tests for COVID-19.”

The FDA said the device was 91.2% accurate at identifying positive test samples and 99.3% accurate at identifying negative test samples.

“InspectIR expects to be able to produce approximately 100 instruments per week, which can each be used to evaluate approximately 160 samples per day,” the agency said. “At this level of production, testing capacity using the InspectIR COVID-19 Breathalyzer is expected to increase by approximately 64,000 samples per month.”

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Released: April 2022


Quatrefolic® Increases Pregnancy Potential: New Study

International Journal of Environmental Research and Public Health has just published a new retrospective study investigating the role of supplementation with vitamin B complex (5-methyltetrahydrofolate as Quatrefolic® from Gnosis by Lesaffre plus vitamins B12 and B6) versus folic acid (FA) on pregnancy outcomes (clinical pregnancy, pregnancy loss, and live birth) in infertile women undergoing Assisted Reproductive Technologies (ART). Results showed that the Quatrefolic® group had a higher chance of clinical pregnancy and live birth than those supplementing with FA alone.

ART represent widely used procedures for the control and treatment of infertility, despite that most procedures remain unsuccessful, and the reason for this lack of success may have a multifactorial origin. Reproductive success is highly influenced by the female pre-conceptional health, including nutrition and micronutrient levels, which may play a pivotal role in this initial phase.

According to the study, "5-Methyltetrahydrofolate and Vitamin B12 Supplementation is Associated with Clinical Pregnancy, and Live Birth in Women Undergoing Assisted Reproductive Technology" [1], the homocysteine pathway in the preconception period should be evaluated to highlight micronutrient de?ciencies and warrants optimal multivitamin supplementation. This is important for Assisted Reproduction, as FA is considered the standard supplementation for preconception care. The retrospective study aimed at investigating the role of a vitamin B complex (5-methyltetrahydrofolate, vitamin B12, vitamin B6) supplement use compared with the role of only FA supplement use, in relation to clinical pregnancy and live birth in infertile women undergoing homologous ART.

The researchers recruited 269 infertile women: 111 were supplemented daily with Quatrefolic® associated with other vitamin B and 158 with only FA. In the vitamin B complex-supplemented women, the mean number of Metaphase II oocytes and the pronuclear stage (2PN) fertilization rate score were higher than in women supplemented with FA.

The results showed a higher percentage of women in the vitamin B complex group had a clinical pregnancy and live birth in comparison to the FA group, leading the authors to conclude that “women undergoing homologous ART supplemented with 5-MTHF and vitamin B12, have a higher chance of clinical pregnancy and live birth in comparison to those supplemented with only folic acid. Further prospective studies and randomized clinical trial are needed to elucidate the effects of folate, vitamin B12, and homocysteine pathway in improving pregnancy outcomes in women after ART. If our ?ndings were con?rmed, this relatively inexpensive supplementation with vitamin B complex might be considered in clinical practice, particularly in women undergoing ART.”

“We are excited to see the increasing volume of publications related to the role of the biologically active form 5-MTHF as a better option than folic acid in fertility problems and pregnancy outcomes,” says Silvia Pisoni, global market manager of reproduction and women’s health with Gnosis by Lesaffre, noting that this study strengthens the positioning of Quatrefolic® in fertility, already shown by observational studies conducted on couples with a history fertility problem such as recurrent fetal loss, premature ovarian insufficiency, or abnormal sperm parameters.[2-5] “Quatrefolic® is proven to be a real solution with beneficial innovated features that match totally to the requirements of physicians and doctors to provide effective solutions and increase consumers’ compliance.”

References:

1 Cirillo, M.; Fucci, R.; Rubini, S.; Coccia, M.E.; Fatini, C.5-Methyltetrahydrofolate and Vitamin B12 Supplementation Is Associated with Clinical Pregnancy and Live Birth in Women Undergoing Assisted Reproductive Technology. Int. J. Environ. Res. Public Health 2021, 18, 12280. https://doi.org/10.3390/ijerph182312280

2 Servy EJ et al. J Assist Reprod Genet 2018; 35:1431–5.

3 Servy EJ, Ménézo Y. Clin Obstet Gynecol Reprod Med 2017; 3.

4 Clément A et al. J Gynecol Obstet Hum Reprod 2020; 49:101622.

5 Ménézo Y et al. Y. J Assist Reprod Genet 2021.

About Gnosis by Lesaffre

Gnosis by Lesaffre harnesses the power of microorganisms and biotransformation processes like fermentation to cultivate nutritional actives, probiotics, and nutritional and functional yeasts that benefit human health and wellbeing. The team draws on its focused research and applications capabilities to collaborate with nutraceutical and pharmaceutical brands to develop game-changing products for their customers.

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